Pub Date : 2025-01-29DOI: 10.1097/IJG.0000000000002543
Brian A Francis, Vanessa Vera, Joshua Kim, Mahdi M Basha, Bryant Lum, Douglas Grayson, Steven Vold, Mini Balaram, Susan Simonyi, Husam Ansari, Natasha Nayak Kolomeyer
Prcis: In the real-world, retrospective, EXPAND study of consecutive adults with glaucoma, ab-externo gel stent implantation effectively lowered intraocular pressure (34%) and the medication burden (61%), with transient/self-resolving hypotony as the most frequent adverse event (28%).
Purpose: To assess effectiveness and safety of ab-externo gel stent (GS) implantation in glaucoma.
Methods: Multicenter, real-world, retrospective study. Consecutive adults with glaucoma and ab-externo GS implantation (with/without phacoemulsification or open/closed conjunctiva) ≥12 months before study entry. Data were extracted between the baseline/preoperative and last follow-up visit or date of secondary surgical intervention (SSI). Primary effectiveness endpoint: proportion of primary eyes (first eye in bilaterally implanted patients) at Month 12 (M12) achieving ≥20% intraocular pressure (IOP) reduction from baseline without medication increase, clinical hypotony, vision loss to counting fingers, or SSI. Secondary effectiveness endpoints included complete success (IOP ≤18 mmHg and ≥20% IOP reduction from medicated baseline without medication, clinical hypotony, or SSI); qualified success (same but without medication increase); and needling rate. Key safety endpoints (all eyes): intraoperative complications, postoperative adverse events (AEs), and SSIs.
Results: The safety population included 466 eyes; 80.7% received the GS alone and 85.0% were implanted with closed conjunctiva. At M12, 39.1% of all primary eyes (N=413) and 54.9% of primary eyes with IOP and medication data at baseline and M12 (N=213) achieved the primary endpoint. At M12 among all primary eyes, the complete success, qualified success, and needling rates were 33.5%, 56.5%, and 28.6%. Most eyes (97.9%) had no intraoperative complications. The most frequent postoperative AE was transient/self-resolving hypotony (IOP<6 mmHg; 28.1%). Sixty-nine (14.8%) eyes required an SSI.
Conclusions: Ab-externo GS placement effectively lowered IOP and the medication count without unexpected complications/AEs, expanding implantation options based on patients' needs and surgeons' preferences.
{"title":"One-Year Real-World Outcomes of Ab-Externo Gel Stent Placement From the EXPAND Study.","authors":"Brian A Francis, Vanessa Vera, Joshua Kim, Mahdi M Basha, Bryant Lum, Douglas Grayson, Steven Vold, Mini Balaram, Susan Simonyi, Husam Ansari, Natasha Nayak Kolomeyer","doi":"10.1097/IJG.0000000000002543","DOIUrl":"https://doi.org/10.1097/IJG.0000000000002543","url":null,"abstract":"<p><strong>Prcis: </strong>In the real-world, retrospective, EXPAND study of consecutive adults with glaucoma, ab-externo gel stent implantation effectively lowered intraocular pressure (34%) and the medication burden (61%), with transient/self-resolving hypotony as the most frequent adverse event (28%).</p><p><strong>Purpose: </strong>To assess effectiveness and safety of ab-externo gel stent (GS) implantation in glaucoma.</p><p><strong>Methods: </strong>Multicenter, real-world, retrospective study. Consecutive adults with glaucoma and ab-externo GS implantation (with/without phacoemulsification or open/closed conjunctiva) ≥12 months before study entry. Data were extracted between the baseline/preoperative and last follow-up visit or date of secondary surgical intervention (SSI). Primary effectiveness endpoint: proportion of primary eyes (first eye in bilaterally implanted patients) at Month 12 (M12) achieving ≥20% intraocular pressure (IOP) reduction from baseline without medication increase, clinical hypotony, vision loss to counting fingers, or SSI. Secondary effectiveness endpoints included complete success (IOP ≤18 mmHg and ≥20% IOP reduction from medicated baseline without medication, clinical hypotony, or SSI); qualified success (same but without medication increase); and needling rate. Key safety endpoints (all eyes): intraoperative complications, postoperative adverse events (AEs), and SSIs.</p><p><strong>Results: </strong>The safety population included 466 eyes; 80.7% received the GS alone and 85.0% were implanted with closed conjunctiva. At M12, 39.1% of all primary eyes (N=413) and 54.9% of primary eyes with IOP and medication data at baseline and M12 (N=213) achieved the primary endpoint. At M12 among all primary eyes, the complete success, qualified success, and needling rates were 33.5%, 56.5%, and 28.6%. Most eyes (97.9%) had no intraoperative complications. The most frequent postoperative AE was transient/self-resolving hypotony (IOP<6 mmHg; 28.1%). Sixty-nine (14.8%) eyes required an SSI.</p><p><strong>Conclusions: </strong>Ab-externo GS placement effectively lowered IOP and the medication count without unexpected complications/AEs, expanding implantation options based on patients' needs and surgeons' preferences.</p>","PeriodicalId":15938,"journal":{"name":"Journal of Glaucoma","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143059279","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Prcis: Cognitive impairment in multiple domains was observed in primary open angle glaucoma patients as compared to age and gender matched healthy controls.
Objective: Evaluation of cognitive impairment in individuals with Primary Open Angle Glaucoma (POAG).
Methods: In this case-control study, individuals with POAG (cases, n=70) were compared with age- and sex-matched healthy individuals (controls, n=70) using detailed ophthalmological evaluation, cognitive assessment and serum cortisol level. A multitude of tests were employed to comprehensively assess various domains of cognitive function: Addenbrooke Cognitive Examination (ACE-III; attention/orientation, memory, language, verbal fluency, and visuospatial skills), Post Graduate Institute Memory Scale (PGIMS; verbal and non verbal memory), Wisconsin Card Sorting Test (WCST; nonverbal executive functions), Go No-Go task (GNG; inhibitory control), and Trail Making Test (TMT; attention and working memory).
Results: Intraocular pressure and cup disc ratio were significantly higher (P <0.001) while retinal nerve fibre layer (RNFL) thickness and mean deviation were significantly lower in cases as compared to controls. Cases had significantly lower scores on ACE-III and PGIMS (P<0.001) and longer test completion time in TMT-A (P=0.001). The performance of cases was also significantly worse on most parameters of the WCST and GNG tasks. Serum cortisol level was significantly higher in cases (11.75±7.41 mcg/dl) compared to controls (7.93±2.39 mcg/dl; P=0.02). A significant correlation was observed between serum cortisol level and WCST correct response (P=0.04), WCST error response (P=0.002) and total time taken in TMT-A (P=0.03).Visual field mean deviation also exhibited a significant correlation with serum cortisol level (P<0.001) and total time taken on WCST (P=0.03) and TMT-A (P=0.03).
Conclusion: Individuals with POAG exhibited higher cognitive impairment and raised serum cortisol levels than age-matched healthy controls. Early recognition and management of cognitive impairment are pivotal for enhancing the quality of life and implementing comprehensive glaucoma care.
{"title":"Cognitive Impairment in Primary Open Angle Glaucoma: A Case Control Study.","authors":"Muskan Garg, Neha Midha, Rohit Verma, Vivek Gupta, Dewang Angmo, Thirumurthy Velpandian, Prafulla Kumar Maharana, Sujata Satapathy, Namrata Sharma, Tanuj Dada","doi":"10.1097/IJG.0000000000002544","DOIUrl":"https://doi.org/10.1097/IJG.0000000000002544","url":null,"abstract":"<p><strong>Prcis: </strong>Cognitive impairment in multiple domains was observed in primary open angle glaucoma patients as compared to age and gender matched healthy controls.</p><p><strong>Objective: </strong>Evaluation of cognitive impairment in individuals with Primary Open Angle Glaucoma (POAG).</p><p><strong>Methods: </strong>In this case-control study, individuals with POAG (cases, n=70) were compared with age- and sex-matched healthy individuals (controls, n=70) using detailed ophthalmological evaluation, cognitive assessment and serum cortisol level. A multitude of tests were employed to comprehensively assess various domains of cognitive function: Addenbrooke Cognitive Examination (ACE-III; attention/orientation, memory, language, verbal fluency, and visuospatial skills), Post Graduate Institute Memory Scale (PGIMS; verbal and non verbal memory), Wisconsin Card Sorting Test (WCST; nonverbal executive functions), Go No-Go task (GNG; inhibitory control), and Trail Making Test (TMT; attention and working memory).</p><p><strong>Results: </strong>Intraocular pressure and cup disc ratio were significantly higher (P <0.001) while retinal nerve fibre layer (RNFL) thickness and mean deviation were significantly lower in cases as compared to controls. Cases had significantly lower scores on ACE-III and PGIMS (P<0.001) and longer test completion time in TMT-A (P=0.001). The performance of cases was also significantly worse on most parameters of the WCST and GNG tasks. Serum cortisol level was significantly higher in cases (11.75±7.41 mcg/dl) compared to controls (7.93±2.39 mcg/dl; P=0.02). A significant correlation was observed between serum cortisol level and WCST correct response (P=0.04), WCST error response (P=0.002) and total time taken in TMT-A (P=0.03).Visual field mean deviation also exhibited a significant correlation with serum cortisol level (P<0.001) and total time taken on WCST (P=0.03) and TMT-A (P=0.03).</p><p><strong>Conclusion: </strong>Individuals with POAG exhibited higher cognitive impairment and raised serum cortisol levels than age-matched healthy controls. Early recognition and management of cognitive impairment are pivotal for enhancing the quality of life and implementing comprehensive glaucoma care.</p>","PeriodicalId":15938,"journal":{"name":"Journal of Glaucoma","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2025-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143059269","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-23DOI: 10.1097/IJG.0000000000002540
Abdelrahman M Tawfik, Rawan A Kasem, Zeyad M Wesh, Sara M Abo Daif, Abdulla Aly Elmansoury, Raouf Korish, Mohammad Bazzazeh, Kai-Yang Chen, Alaa Ramadan, Almoatazbellah A Attalla, Nada M GabAllah
Precis: Glaucoma surgery impacts corneal graft survival differently by procedure type, with GDDs being most effective at reducing intraocular pressure. However, graft survival rates are comparable across trabeculectomy, CPC, and GDDs. Trabeculectomy improves visual acuity best but often requires additional interventions.
Purpose: To investigate the impact of different glaucoma procedures on corneal graft survival and corneal endothelium health.
Methods: We searched PubMed, Cochrane Library, Scopus, and Web of Science, to identify eligible studies. Studies were included based on predetermined criteria. The primary outcome was corneal graft survival, and secondary outcomes included intraocular pressure (IOP) control, visual acuity, antiglaucoma medications, additional glaucoma surgery, and postoperative complications. Meta-analyses were conducted using random-effects models, and heterogeneity was assessed using the (I2) test.
Results: Our results included 27 studies involving 905 patients were analyzed. However, there were no randomized comparative studies. The overall proportion of corneal graft survival at last follow-up was 66.4%, with the three subgroups of trabeculectomy, cyclophotocoagulation (CPC), and Glaucoma drainage devices (GDD) showing similar survival rates of 66.6%, 64.8%, and 65.6%, respectively. Short term graft survival (6 months) was similar across groups, however 2-year survival favoured trabeculectomy. GDDs were the most effective in reducing IOP with an average reduction of 21.4 mmHg compared to 18.9 mmHg for trabeculectomy and 14.8 mmHg for CPC. CPC yielded the best improvement in visual acuity reported as BCVA. GDD required the fewest postoperative antiglaucoma medications. Trabeculectomy had the highest proportion of patients needing additional surgery for glaucoma. The most common complications were hypotony, uveitis and tube obstruction.
Conclusion: There were no significant differences in corneal graft survival rates among various glaucoma surgical techniques, but these findings must be interpreted with caution due to the limitations of primary research. GDDs effectively reduced IOP and minimized the need for antiglaucoma medications. Trabeculectomy may be associated with the greatest visual acuity improvement but may carry a higher likelihood of requiring further glaucoma surgery.
摘要:青光眼手术对角膜移植存活的影响因手术类型不同而不同,GDDs在降低眼压方面最有效。然而,在小梁切除术、CPC和GDDs中,移植物存活率是相当的。小梁切除术改善视力最好,但往往需要额外的干预。目的:探讨不同青光眼手术方式对移植角膜存活及角膜内皮健康的影响。方法:我们检索PubMed、Cochrane Library、Scopus和Web of Science,以确定符合条件的研究。研究是根据预先确定的标准纳入的。主要结果是角膜移植存活,次要结果包括眼压(IOP)控制、视力、抗青光眼药物、额外的青光眼手术和术后并发症。采用随机效应模型进行meta分析,采用(I2)检验评估异质性。结果:我们的结果包括27项研究,涉及905例患者。然而,没有随机比较研究。最后一次随访时角膜移植整体成活率为66.4%,其中小梁切除术、光凝术(CPC)和青光眼引流术(GDD)三个亚组的成活率相似,分别为66.6%、64.8%和65.6%。短期移植物生存(6个月)各组相似,但2年生存有利于小梁切除术。GDDs在降低IOP方面最有效,平均降低21.4 mmHg,而小梁切除术平均降低18.9 mmHg, CPC平均降低14.8 mmHg。CPC的视力改善效果最好,报告为BCVA。GDD术后所需抗青光眼药物最少。青光眼患者需要额外手术的比例最高的是小梁切除术。最常见的并发症是低眼压、葡萄膜炎和输卵管阻塞。结论:不同青光眼手术技术角膜移植存活率无显著差异,但由于初步研究的局限性,必须谨慎解读这些发现。GDDs有效地降低了IOP,减少了对抗青光眼药物的需求。小梁切除术可能与最大的视力改善相关,但可能需要进一步青光眼手术的可能性更高。
{"title":"Impact of Glaucoma Surgery on Corneal Graft Survival After Keratoplasty: A Systematic Review and Meta-Analysis.","authors":"Abdelrahman M Tawfik, Rawan A Kasem, Zeyad M Wesh, Sara M Abo Daif, Abdulla Aly Elmansoury, Raouf Korish, Mohammad Bazzazeh, Kai-Yang Chen, Alaa Ramadan, Almoatazbellah A Attalla, Nada M GabAllah","doi":"10.1097/IJG.0000000000002540","DOIUrl":"https://doi.org/10.1097/IJG.0000000000002540","url":null,"abstract":"<p><strong>Precis: </strong>Glaucoma surgery impacts corneal graft survival differently by procedure type, with GDDs being most effective at reducing intraocular pressure. However, graft survival rates are comparable across trabeculectomy, CPC, and GDDs. Trabeculectomy improves visual acuity best but often requires additional interventions.</p><p><strong>Purpose: </strong>To investigate the impact of different glaucoma procedures on corneal graft survival and corneal endothelium health.</p><p><strong>Methods: </strong>We searched PubMed, Cochrane Library, Scopus, and Web of Science, to identify eligible studies. Studies were included based on predetermined criteria. The primary outcome was corneal graft survival, and secondary outcomes included intraocular pressure (IOP) control, visual acuity, antiglaucoma medications, additional glaucoma surgery, and postoperative complications. Meta-analyses were conducted using random-effects models, and heterogeneity was assessed using the (I2) test.</p><p><strong>Results: </strong>Our results included 27 studies involving 905 patients were analyzed. However, there were no randomized comparative studies. The overall proportion of corneal graft survival at last follow-up was 66.4%, with the three subgroups of trabeculectomy, cyclophotocoagulation (CPC), and Glaucoma drainage devices (GDD) showing similar survival rates of 66.6%, 64.8%, and 65.6%, respectively. Short term graft survival (6 months) was similar across groups, however 2-year survival favoured trabeculectomy. GDDs were the most effective in reducing IOP with an average reduction of 21.4 mmHg compared to 18.9 mmHg for trabeculectomy and 14.8 mmHg for CPC. CPC yielded the best improvement in visual acuity reported as BCVA. GDD required the fewest postoperative antiglaucoma medications. Trabeculectomy had the highest proportion of patients needing additional surgery for glaucoma. The most common complications were hypotony, uveitis and tube obstruction.</p><p><strong>Conclusion: </strong>There were no significant differences in corneal graft survival rates among various glaucoma surgical techniques, but these findings must be interpreted with caution due to the limitations of primary research. GDDs effectively reduced IOP and minimized the need for antiglaucoma medications. Trabeculectomy may be associated with the greatest visual acuity improvement but may carry a higher likelihood of requiring further glaucoma surgery.</p>","PeriodicalId":15938,"journal":{"name":"Journal of Glaucoma","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143006680","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-23DOI: 10.1097/IJG.0000000000002541
Rodanthi Christina Bartzoulianou, Anne L Coleman, M Roy Wilson, Alon Harris, Konstantinos I Bougioukas, Theofanis Pappas, Dimitrios A Giannoulis, Fei Yu, Anastasia Raptou, Grigoria Tzoanou, Fotis Topouzis
Prcis: In 801 participants, corneal hysteresis (CH) was positively associated with female gender and central corneal thickness, and negatively with age and axial length. Diabetes showed no significant association with CH in the adjusted models.
Purpose: To provide values of corneal hysteresis (CH) in an elderly, healthy Greek population and to investigate its association with demographic, ocular, and systemic factors.
Methods: Cross-sectional population-based study. Out of 1,092 participants in the incidence cohort of the Thessaloniki Eye Study (TES) who were re-examined between 2013 and 2015, there were 801 eligible subjects in this study according to pre-specified criteria. All subjects underwent an interview and a comprehensive clinical examination. Demographic data and medical and ophthalmic, family, and smoking histories were recorded. CH was evaluated with Ocular Response Analyzer (ORA).
Results: The mean age of study subjects was 79.7±3.9 years and 345 out of 801 participants (43.1%) were female. The mean CH among all subjects was 10.1±1.5 mmHg. After adjusting for age, gender, central corneal thickness (CCT), axial length (AL), and diabetes, CH was positively associated with female gender (β=0.446; P<0.0001) and CCT (β=0.017; P<0.0001), and negatively associated with age (β=-0.024; P=0.038) and AL (β=-0.181; P<0.0001). There was no association between CH and diabetes (β=0.186; P=0.10). In a supplementary multivariable analysis of a smaller sample size, where we included corneal curvature (CC) as an additional covariate, no association was found between CH and CC (β=-0.235; P=0.26) or age (β=-0.023; P=0.09).
Conclusion: This study outlined variations in CH among a Greek population. CH decreased with advancing age while women had greater CH compared to men. In addition, eyes with thinner corneas and longer AL had lower CH values. No significant associations were found between CH and CC or the presence of diabetes.
{"title":"Factors Associated with Corneal Hysteresis in an Elderly White Population: The Thessaloniki Eye Study.","authors":"Rodanthi Christina Bartzoulianou, Anne L Coleman, M Roy Wilson, Alon Harris, Konstantinos I Bougioukas, Theofanis Pappas, Dimitrios A Giannoulis, Fei Yu, Anastasia Raptou, Grigoria Tzoanou, Fotis Topouzis","doi":"10.1097/IJG.0000000000002541","DOIUrl":"https://doi.org/10.1097/IJG.0000000000002541","url":null,"abstract":"<p><strong>Prcis: </strong>In 801 participants, corneal hysteresis (CH) was positively associated with female gender and central corneal thickness, and negatively with age and axial length. Diabetes showed no significant association with CH in the adjusted models.</p><p><strong>Purpose: </strong>To provide values of corneal hysteresis (CH) in an elderly, healthy Greek population and to investigate its association with demographic, ocular, and systemic factors.</p><p><strong>Methods: </strong>Cross-sectional population-based study. Out of 1,092 participants in the incidence cohort of the Thessaloniki Eye Study (TES) who were re-examined between 2013 and 2015, there were 801 eligible subjects in this study according to pre-specified criteria. All subjects underwent an interview and a comprehensive clinical examination. Demographic data and medical and ophthalmic, family, and smoking histories were recorded. CH was evaluated with Ocular Response Analyzer (ORA).</p><p><strong>Results: </strong>The mean age of study subjects was 79.7±3.9 years and 345 out of 801 participants (43.1%) were female. The mean CH among all subjects was 10.1±1.5 mmHg. After adjusting for age, gender, central corneal thickness (CCT), axial length (AL), and diabetes, CH was positively associated with female gender (β=0.446; P<0.0001) and CCT (β=0.017; P<0.0001), and negatively associated with age (β=-0.024; P=0.038) and AL (β=-0.181; P<0.0001). There was no association between CH and diabetes (β=0.186; P=0.10). In a supplementary multivariable analysis of a smaller sample size, where we included corneal curvature (CC) as an additional covariate, no association was found between CH and CC (β=-0.235; P=0.26) or age (β=-0.023; P=0.09).</p><p><strong>Conclusion: </strong>This study outlined variations in CH among a Greek population. CH decreased with advancing age while women had greater CH compared to men. In addition, eyes with thinner corneas and longer AL had lower CH values. No significant associations were found between CH and CC or the presence of diabetes.</p>","PeriodicalId":15938,"journal":{"name":"Journal of Glaucoma","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143006637","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-23DOI: 10.1097/IJG.0000000000002539
Bryan Chin Hou Ang, Bjorn Kaijun Betzler, Sheng Yang Lim
Purpose: Trabecular micro-bypass devices (TBDs) such as the iStent series (Glaukos Corporation, Laguna Hills, CA), are effective in reducing intraocular pressure (IOP). However, precise placement of TBDs is crucial in achieving surgical efficacy, as device malpositioning may lead to suboptimal IOP reduction. We demonstrate two novel intra-operative signs to aid confirmation of accurate iStent placement, without reliance on imaging technologies.
Methods: Surgical technique report with video accompaniment.
Surgical technique: Two intra-operative clinical signs which confirm optimal iStent placement are described: (1) Luminal Blood Reflux - achieved by gently decompressing the anterior chamber, with or without flushing of the stent lumen with balanced salt solution (BSS), thereby confirming stent positioning in the Schlemm's Canal (SC). (2) Schlemm's Bidirectional Fluid Wave (SBFW) - observable when flushing with BSS, suggesting fluid movement in the canal segments adjacent to the iStent device, thereby confirming stent patency and positioning in the SC.
Conclusion: The identified signs are useful, feasible and reproducible indicators of accurate iStent placement. Future studies may evaluate the application of these confirmatory manoeuvres in diverse clinical contexts and further establish correlation with clinical outcomes.
{"title":"Schlemm's Bidirectional Fluid Wave and Luminal Blood Reflux as Novel Intra-Operative Signs Confirming Optimal Placement of the iStent.","authors":"Bryan Chin Hou Ang, Bjorn Kaijun Betzler, Sheng Yang Lim","doi":"10.1097/IJG.0000000000002539","DOIUrl":"https://doi.org/10.1097/IJG.0000000000002539","url":null,"abstract":"<p><strong>Purpose: </strong>Trabecular micro-bypass devices (TBDs) such as the iStent series (Glaukos Corporation, Laguna Hills, CA), are effective in reducing intraocular pressure (IOP). However, precise placement of TBDs is crucial in achieving surgical efficacy, as device malpositioning may lead to suboptimal IOP reduction. We demonstrate two novel intra-operative signs to aid confirmation of accurate iStent placement, without reliance on imaging technologies.</p><p><strong>Methods: </strong>Surgical technique report with video accompaniment.</p><p><strong>Surgical technique: </strong>Two intra-operative clinical signs which confirm optimal iStent placement are described: (1) Luminal Blood Reflux - achieved by gently decompressing the anterior chamber, with or without flushing of the stent lumen with balanced salt solution (BSS), thereby confirming stent positioning in the Schlemm's Canal (SC). (2) Schlemm's Bidirectional Fluid Wave (SBFW) - observable when flushing with BSS, suggesting fluid movement in the canal segments adjacent to the iStent device, thereby confirming stent patency and positioning in the SC.</p><p><strong>Conclusion: </strong>The identified signs are useful, feasible and reproducible indicators of accurate iStent placement. Future studies may evaluate the application of these confirmatory manoeuvres in diverse clinical contexts and further establish correlation with clinical outcomes.</p>","PeriodicalId":15938,"journal":{"name":"Journal of Glaucoma","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143006683","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-21DOI: 10.1097/IJG.0000000000002538
Tiki Ewing, Natalia Correa, Sharon Armarnik, Christopher J Lyons
Precis: Goniotomy is effective in managing intraocular pressure in childhood glaucoma secondary to uveitis with cumulative probability of success 0.94 after 1 year and 0.77 after 5 years.
Objective: To evaluate the long-term success of goniotomy for childhood glaucoma secondary to chronic uveitis.
Methods: Retrospective chart review of all children treated with goniotomy for this indication from 2001 to 2023. Post operative success was defined as IOP ≥ 6 and ≤ 21 mmHg after 1 or 2 goniotomies, without the need for further surgical intervention or sight-threatening complication.
Results: 31 eyes of 21 patients were included. Mean age at first goniotomy was 10.3 years (range 6.6- 15.7 years) with uveitis diagnosed on average 4.7 years earlier. Mean pre-operative IOP was 28.8 mmHg, on a median of 4 topical agents. Mean follow-up post-goniotomy was 6.8 years (Median 5.7 years) and average post operative IOP at 1, 5 and 8 years post-operatively was 15.9, 15.2 and 15.6 mmHg respectively. At most recent follow-up, 24 eyes (77.4%) were a surgical success. Of these, 5 (21%) needed a second goniotomy to achieve this, and 5 (21%) needed anti-glaucoma drops to maintain IOP ≤21 mmHg (two of these were cases who also underwent a second goniotomy). There were no major complications including loss of inflammatory control.
Conclusion: We confirm that this quick, safe, conjunctival sparing primary approach is safe and effective in this context, and early success rates are usually maintained in the long-term. If stable inflammatory control can be achieved pre-operatively, we recommend it as first line treatment for children with childhood glaucoma secondary to uveitis.
{"title":"Goniotomy for Childhood Glaucoma Secondary to Uveitis: Long-term Outcomes.","authors":"Tiki Ewing, Natalia Correa, Sharon Armarnik, Christopher J Lyons","doi":"10.1097/IJG.0000000000002538","DOIUrl":"https://doi.org/10.1097/IJG.0000000000002538","url":null,"abstract":"<p><strong>Precis: </strong>Goniotomy is effective in managing intraocular pressure in childhood glaucoma secondary to uveitis with cumulative probability of success 0.94 after 1 year and 0.77 after 5 years.</p><p><strong>Objective: </strong>To evaluate the long-term success of goniotomy for childhood glaucoma secondary to chronic uveitis.</p><p><strong>Methods: </strong>Retrospective chart review of all children treated with goniotomy for this indication from 2001 to 2023. Post operative success was defined as IOP ≥ 6 and ≤ 21 mmHg after 1 or 2 goniotomies, without the need for further surgical intervention or sight-threatening complication.</p><p><strong>Results: </strong>31 eyes of 21 patients were included. Mean age at first goniotomy was 10.3 years (range 6.6- 15.7 years) with uveitis diagnosed on average 4.7 years earlier. Mean pre-operative IOP was 28.8 mmHg, on a median of 4 topical agents. Mean follow-up post-goniotomy was 6.8 years (Median 5.7 years) and average post operative IOP at 1, 5 and 8 years post-operatively was 15.9, 15.2 and 15.6 mmHg respectively. At most recent follow-up, 24 eyes (77.4%) were a surgical success. Of these, 5 (21%) needed a second goniotomy to achieve this, and 5 (21%) needed anti-glaucoma drops to maintain IOP ≤21 mmHg (two of these were cases who also underwent a second goniotomy). There were no major complications including loss of inflammatory control.</p><p><strong>Conclusion: </strong>We confirm that this quick, safe, conjunctival sparing primary approach is safe and effective in this context, and early success rates are usually maintained in the long-term. If stable inflammatory control can be achieved pre-operatively, we recommend it as first line treatment for children with childhood glaucoma secondary to uveitis.</p>","PeriodicalId":15938,"journal":{"name":"Journal of Glaucoma","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2025-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143006667","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-16DOI: 10.1097/IJG.0000000000002537
Tanuj Dada, Ashi Gupta, Nitika Beri, Alex S Huang, Namrata Sharma, Dewang Angmo, Prafulla K Maharana, Amar Pujari
Prcis: Trabecular cutting minimally invasive glaucoma surgery like bent ab interno needle goniectomy (BANG) when performed in baseline aqueous angiography identified low aqueous humor outflow regions, results in greater success of intraocular pressure reduction.
Purpose: To study the efficacy of Bent Ab Interno Needle Goniectomy (BANG) in high versus low aqueous humor outflow (AHO) regions as determined by Aqueous Angiography(AA) in patients with primary open angle glaucoma (POAG).
Methods: A prospective, single-centre, pilot, randomized control trial recruited 30 eyes of 30 patients of POAG and visually significant cataract (45-80 y) and were randomised into two groups ("A": BANG performed in the high-flow regions and "B": BANG performed in the low-flow regions) of 15 each. AA was performed using indocyanine green dye (0.1%) to identify baseline high- and low-flow regions of the AHO pathways followed by BANG in these respective regions as per randomisation. Preoperative and postoperative data on IOP, number of antiglaucoma medications (AGMs) and any complications were noted over 6 months. Overall success was defined as achieving an IOP ≤15 mm Hg and ≥6 mm Hg at 6 months of follow-up with AGMs (qualified success) or without AGMs (complete success).
Results: AA revealed high-flow regions of AHO pathways in the nasal quadrant and low-flow regions of AHO pathways in the temporal quadrant in all 30 patients. Both groups had comparable demographic composition [group A age: 65.3±6.48 y and male: female (14:1) and group B age: 64.6±7.08 y and male: female (13:2)]. The mean preoperative IOPs [group A (17.27±3.43 mm Hg); group B (17.60±5.42 mm Hg)] (P=0.842) and mean postoperative IOP at 6 months [group A (15.6±4.98 mm Hg); group B (13.13±2.29 mm Hg)] (P=0.09) were similar. However, lower qualified success was seen in group A (40.00%) compared to group B (86.67%; P=0.021). Survival in Kaplan-Meier analysis was higher in group B (P=0.021). Complications were comparable in both groups.
Conclusion: Short-term results of BANG in low-flow AHO regions show enhanced success compared to those in high-flow AHO regions. This study suggests that trabecular cutting minimally invasive glaucoma surgeries (like BANG) may be performed in baseline low-flow AHO regions (temporal quadrant) instead of the high-flow AHO (nasal quadrant) regions.
应用:小梁切割微创青光眼手术,如弯腹针间角骨切除术(BANG),当基线水血管造影确定低房水流出区时,可以更成功地降低眼压。目的:探讨经水血管造影(AA)测定原发性开角型青光眼(POAG)患者房水高流出区与低流出区房水高流出区之间的差异,探讨弯针式骨切除术(BANG)的疗效。方法:一项前瞻性、单中心、先导、随机对照试验,招募30例POAG合并显著性白内障(45-80岁)患者的30只眼,随机分为两组(A组:在高流区行BANG, B组:在低流区行BANG),每组15只。使用吲哚菁绿染料(0.1%)进行AA,以确定who途径的基线高流量和低流量区域,然后根据随机化在这些相应区域进行BANG。术前和术后6个月的IOP数据、抗青光眼药物(AGMs)数量和任何并发症记录。总体成功被定义为在随访6个月时,有agm(合格成功)或无agm(完全成功)的IOP≤15mm Hg和≥6mm Hg。结果:在所有30例患者中,AA均显示鼻象限的ho通路高流区和颞象限的ho通路低流区。两组人口构成具有可比性[A组年龄:65.3±6.48岁,男女比(14:1);B组年龄:64.6±7.08岁,男女比(13:2)]。A组术前平均IOPs(17.27±3.43 mm Hg);B组(17.60±5.42 mm Hg) (P=0.842),术后6个月平均IOP [A组(15.6±4.98 mm Hg)];B组(13.13±2.29 mm Hg)差异无统计学意义(P=0.09)。但A组的合格率(40.00%)低于B组(86.67%);P = 0.021)。Kaplan-Meier分析显示B组生存率较高(P=0.021)。两组并发症具有可比性。结论:与高流量地区相比,低流量地区BANG的短期结果显示出更高的成功率。本研究表明,小梁切割微创青光眼手术(如BANG)可以在基线低流量的who区域(颞象限)进行,而不是在高流量的who区域(鼻象限)进行。
{"title":"Aqueous Angiography Guided Bent Ab Interno Needle Goniectomy in High versus Low Aqueous Humor Outflow Regions in POAG: A Pilot RCT.","authors":"Tanuj Dada, Ashi Gupta, Nitika Beri, Alex S Huang, Namrata Sharma, Dewang Angmo, Prafulla K Maharana, Amar Pujari","doi":"10.1097/IJG.0000000000002537","DOIUrl":"10.1097/IJG.0000000000002537","url":null,"abstract":"<p><strong>Prcis: </strong>Trabecular cutting minimally invasive glaucoma surgery like bent ab interno needle goniectomy (BANG) when performed in baseline aqueous angiography identified low aqueous humor outflow regions, results in greater success of intraocular pressure reduction.</p><p><strong>Purpose: </strong>To study the efficacy of Bent Ab Interno Needle Goniectomy (BANG) in high versus low aqueous humor outflow (AHO) regions as determined by Aqueous Angiography(AA) in patients with primary open angle glaucoma (POAG).</p><p><strong>Methods: </strong>A prospective, single-centre, pilot, randomized control trial recruited 30 eyes of 30 patients of POAG and visually significant cataract (45-80 y) and were randomised into two groups (\"A\": BANG performed in the high-flow regions and \"B\": BANG performed in the low-flow regions) of 15 each. AA was performed using indocyanine green dye (0.1%) to identify baseline high- and low-flow regions of the AHO pathways followed by BANG in these respective regions as per randomisation. Preoperative and postoperative data on IOP, number of antiglaucoma medications (AGMs) and any complications were noted over 6 months. Overall success was defined as achieving an IOP ≤15 mm Hg and ≥6 mm Hg at 6 months of follow-up with AGMs (qualified success) or without AGMs (complete success).</p><p><strong>Results: </strong>AA revealed high-flow regions of AHO pathways in the nasal quadrant and low-flow regions of AHO pathways in the temporal quadrant in all 30 patients. Both groups had comparable demographic composition [group A age: 65.3±6.48 y and male: female (14:1) and group B age: 64.6±7.08 y and male: female (13:2)]. The mean preoperative IOPs [group A (17.27±3.43 mm Hg); group B (17.60±5.42 mm Hg)] (P=0.842) and mean postoperative IOP at 6 months [group A (15.6±4.98 mm Hg); group B (13.13±2.29 mm Hg)] (P=0.09) were similar. However, lower qualified success was seen in group A (40.00%) compared to group B (86.67%; P=0.021). Survival in Kaplan-Meier analysis was higher in group B (P=0.021). Complications were comparable in both groups.</p><p><strong>Conclusion: </strong>Short-term results of BANG in low-flow AHO regions show enhanced success compared to those in high-flow AHO regions. This study suggests that trabecular cutting minimally invasive glaucoma surgeries (like BANG) may be performed in baseline low-flow AHO regions (temporal quadrant) instead of the high-flow AHO (nasal quadrant) regions.</p>","PeriodicalId":15938,"journal":{"name":"Journal of Glaucoma","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2025-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143006556","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-16DOI: 10.1097/IJG.0000000000002535
Karl Mercieca, Matthew Azzopardi, Neeru A Vallabh, Cristina Cristian, Verena Prokosch, Vincent Dubois, Christopher Hemmerdinger, Stefano De Cillà, Divya Mathews, Andre Mermoud, Matthias C Grieshaber, Gordana Sunaric Mégevand, Nitin Anand, Alessandro Rabiolo
Prcis: Deep sclerectomy (DS) and canaloplasty provide better intraocular pressure (IOP) control than viscocanalostomy. DS required less glaucoma medications but more interventions to reach target IOP.
Purpose: To compare real-world outcomes of three non-penetrating glaucoma surgery (NPGS) techniques.
Methods: Retrospective, cohort study of consecutive patients undergoing canaloplasty (CP), deep sclerectomy (DS), and viscocanalostomy (VC), across nine European glaucoma units. Four intraocular pressure (IOP) criteria were used to define success at 2-year follow-up: (A)IOP≤21 mmHg and ≥20% reduction; (B)IOP≤18 mmHg and ≥20% reduction; (C)IOP≤15 mmHg and ≥25% reduction; (D)IOP≤12 mmHg and ≥30% reduction. Secondary outcomes included IOP control, BCVA, number of medications over time, risk factors for failure, complications, and post-operative interventions. Success was distinguished as qualified or complete, if reached with or without antiglaucoma medications, respectively.
Results: 600 eyes (545 patients) undergoing standalone CP (201 eyes), DS (200 eyes), and VC (199 eyes) were included. Qualified success rates of CP, DS, and VP at 24 months were, respectively: (Criterion A) 85.1%, 67.6% and 64.6%; (Criterion B) 85.1%, 66.1% and 58.6%; (Criterion C) 76.6%, 55.5% and 39.0%; (Criterion D) 27.7%, 28.5% and 22.1%. Success rates were significantly different across the three techniques (P=0.04 or below), except for complete success according to criterion A (P=0.07). Mean IOP(±SD) reduced from 25.2(±6.9), 20.5(±6.7), and 22.7(±7.2)mmHg pre-operatively to 13.1(±3.1), 12.9(±4.5), and 14.7(±4.6)mmHg at post-operative year 2 in the CP, DS, and VC groups respectively (P<0.001 between pre-operative and post-operative time points for all groups).
Conclusions: All three NPGS provide sustained IOP reduction, but DS and CP provide better success rates and IOP control. Success rates were low for the most stringent cut-offs, suggesting that other techniques such as trabeculectomy may be indicated when a very low target IOP is demanded.
{"title":"Comparison of Outcomes of Deep Sclerectomy, Canaloplasty, and Viscocanaloplasty: A Multi-Centred Study.","authors":"Karl Mercieca, Matthew Azzopardi, Neeru A Vallabh, Cristina Cristian, Verena Prokosch, Vincent Dubois, Christopher Hemmerdinger, Stefano De Cillà, Divya Mathews, Andre Mermoud, Matthias C Grieshaber, Gordana Sunaric Mégevand, Nitin Anand, Alessandro Rabiolo","doi":"10.1097/IJG.0000000000002535","DOIUrl":"https://doi.org/10.1097/IJG.0000000000002535","url":null,"abstract":"<p><strong>Prcis: </strong>Deep sclerectomy (DS) and canaloplasty provide better intraocular pressure (IOP) control than viscocanalostomy. DS required less glaucoma medications but more interventions to reach target IOP.</p><p><strong>Purpose: </strong>To compare real-world outcomes of three non-penetrating glaucoma surgery (NPGS) techniques.</p><p><strong>Methods: </strong>Retrospective, cohort study of consecutive patients undergoing canaloplasty (CP), deep sclerectomy (DS), and viscocanalostomy (VC), across nine European glaucoma units. Four intraocular pressure (IOP) criteria were used to define success at 2-year follow-up: (A)IOP≤21 mmHg and ≥20% reduction; (B)IOP≤18 mmHg and ≥20% reduction; (C)IOP≤15 mmHg and ≥25% reduction; (D)IOP≤12 mmHg and ≥30% reduction. Secondary outcomes included IOP control, BCVA, number of medications over time, risk factors for failure, complications, and post-operative interventions. Success was distinguished as qualified or complete, if reached with or without antiglaucoma medications, respectively.</p><p><strong>Results: </strong>600 eyes (545 patients) undergoing standalone CP (201 eyes), DS (200 eyes), and VC (199 eyes) were included. Qualified success rates of CP, DS, and VP at 24 months were, respectively: (Criterion A) 85.1%, 67.6% and 64.6%; (Criterion B) 85.1%, 66.1% and 58.6%; (Criterion C) 76.6%, 55.5% and 39.0%; (Criterion D) 27.7%, 28.5% and 22.1%. Success rates were significantly different across the three techniques (P=0.04 or below), except for complete success according to criterion A (P=0.07). Mean IOP(±SD) reduced from 25.2(±6.9), 20.5(±6.7), and 22.7(±7.2)mmHg pre-operatively to 13.1(±3.1), 12.9(±4.5), and 14.7(±4.6)mmHg at post-operative year 2 in the CP, DS, and VC groups respectively (P<0.001 between pre-operative and post-operative time points for all groups).</p><p><strong>Conclusions: </strong>All three NPGS provide sustained IOP reduction, but DS and CP provide better success rates and IOP control. Success rates were low for the most stringent cut-offs, suggesting that other techniques such as trabeculectomy may be indicated when a very low target IOP is demanded.</p>","PeriodicalId":15938,"journal":{"name":"Journal of Glaucoma","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2025-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143006565","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Prcis: Preservative-free omidenepag isopropyl (OMDI) 0.002% ophthalmic solution and OMDI 0.002% ophthalmic solution preserved with benzalkonium chloride were bioequivalent in lowering intraocular pressure after 4 weeks' treatment in patients with primary open-angle glaucoma or ocular hypertension.
Purpose: Preservatives in ophthalmic solutions for lowering intraocular pressure (IOP) are associated with ocular surface disease. The DAISY study evaluated the bioequivalence of preservative-free omidenepag isopropyl (OMDI) 0.002% ophthalmic solution (DE-117B), with OMDI 0.002% preserved with benzalkonium chloride (BAK).
Methods: DAISY was a phase 3, randomized, evaluator-masked, crossover study conducted in Japan. Patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT) were randomized 1:1 to DE-117B or OMDI 0.002% for 4 weeks (period 1) then crossed over for 4 weeks (period 2). A 4-week washout preceded both periods. The primary efficacy endpoint was mean diurnal (MD) IOP at Week 4 (combined periods 1 and 2). Bioequivalence between DE-117B and OMDI was defined as 95% confidence interval (CI) between -1.5 and 1.5 for least-squares (LS) mean between-group difference in MD IOP. Adverse events were monitored.
Results: Of 74 patients enrolled, 38 were randomized to DE-117B then OMDI, and 36 were randomized to OMDI then DE-117B. DE-117B and OMDI demonstrated bioequivalence at Week 4 (MD IOP±standard deviation in summary statistics: 17.76±2.05 mm Hg [DE-117B] vs. 17.71±2.01 mm Hg [OMDI]; LS mean±standard error between-group difference in linear mixed effects model: -0.02±0.18 mm Hg [95% CI -0.38 to 0.35]). DE-117B versus OMDI was associated with numerically lower overall ocular discomfort.
Conclusions: Preservative-free DE-117B and BAK-containing OMDI were bioequivalent in lowering IOP after 4 weeks' treatment in Japanese patients with POAG or OHT. DE-117B was well tolerated with a similar safety profile to OMDI.
结果:无防腐剂的omidenepag异丙基(OMDI) 0.002%眼液与用苯扎氯铵保存的OMDI 0.002%眼液在治疗4周后降低原发性开角型青光眼或高眼压患者的眼压具有生物等效性。目的:降低眼压(IOP)的眼液中的防腐剂与眼表疾病有关。DAISY研究评估了不含防腐剂的omidenepag异丙基(OMDI) 0.002%眼科溶液(DE-117B)与0.002%的OMDI用苯扎氯铵(BAK)保存的生物等效性。方法:DAISY是一项在日本进行的3期、随机、评估者屏蔽、交叉研究。原发性开角型青光眼(POAG)或高眼压(OHT)患者以1:1的比例随机分配到DE-117B或0.002%的OMDI组,为期4周(第一阶段),然后交叉4周(第二阶段)。在这两个阶段之前进行为期4周的洗脱。主要疗效终点是第4周(联合第1和第2期)的平均每日(MD) IOP。DE-117B和OMDI之间的生物等效性定义为最小二乘(LS)组间平均MD IOP差异的95%置信区间(CI)在-1.5和1.5之间。监测不良事件。结果:74例入组患者中,38例随机接受DE-117B后再接受OMDI治疗,36例随机接受OMDI后再接受DE-117B治疗。DE-117B和OMDI在第4周表现出生物等效性(MD IOP±汇总统计标准差:17.76±2.05 mm Hg [DE-117B] vs. 17.71±2.01 mm Hg [OMDI];线性混合效应模型的LS平均值±标准误差组间差异:-0.02±0.18 mm Hg [95% CI -0.38 ~ 0.35])。DE-117B与OMDI相比,整体眼部不适程度较低。结论:在日本POAG或OHT患者治疗4周后,无防腐剂DE-117B和含bak的OMDI在降低IOP方面具有生物等效性。DE-117B耐受性良好,安全性与OMDI相似。
{"title":"Bioequivalence of Preservative-free and Preserved Omidenepag Isopropyl (OMDI) 0.002% Ophthalmic Solutions in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: Results from the Phase 3 DAISY Study.","authors":"Makoto Aihara, Fenghe Lu, Toshihiro Ikeda, Noriko Odani-Kawabata","doi":"10.1097/IJG.0000000000002533","DOIUrl":"10.1097/IJG.0000000000002533","url":null,"abstract":"<p><strong>Prcis: </strong>Preservative-free omidenepag isopropyl (OMDI) 0.002% ophthalmic solution and OMDI 0.002% ophthalmic solution preserved with benzalkonium chloride were bioequivalent in lowering intraocular pressure after 4 weeks' treatment in patients with primary open-angle glaucoma or ocular hypertension.</p><p><strong>Purpose: </strong>Preservatives in ophthalmic solutions for lowering intraocular pressure (IOP) are associated with ocular surface disease. The DAISY study evaluated the bioequivalence of preservative-free omidenepag isopropyl (OMDI) 0.002% ophthalmic solution (DE-117B), with OMDI 0.002% preserved with benzalkonium chloride (BAK).</p><p><strong>Methods: </strong>DAISY was a phase 3, randomized, evaluator-masked, crossover study conducted in Japan. Patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT) were randomized 1:1 to DE-117B or OMDI 0.002% for 4 weeks (period 1) then crossed over for 4 weeks (period 2). A 4-week washout preceded both periods. The primary efficacy endpoint was mean diurnal (MD) IOP at Week 4 (combined periods 1 and 2). Bioequivalence between DE-117B and OMDI was defined as 95% confidence interval (CI) between -1.5 and 1.5 for least-squares (LS) mean between-group difference in MD IOP. Adverse events were monitored.</p><p><strong>Results: </strong>Of 74 patients enrolled, 38 were randomized to DE-117B then OMDI, and 36 were randomized to OMDI then DE-117B. DE-117B and OMDI demonstrated bioequivalence at Week 4 (MD IOP±standard deviation in summary statistics: 17.76±2.05 mm Hg [DE-117B] vs. 17.71±2.01 mm Hg [OMDI]; LS mean±standard error between-group difference in linear mixed effects model: -0.02±0.18 mm Hg [95% CI -0.38 to 0.35]). DE-117B versus OMDI was associated with numerically lower overall ocular discomfort.</p><p><strong>Conclusions: </strong>Preservative-free DE-117B and BAK-containing OMDI were bioequivalent in lowering IOP after 4 weeks' treatment in Japanese patients with POAG or OHT. DE-117B was well tolerated with a similar safety profile to OMDI.</p>","PeriodicalId":15938,"journal":{"name":"Journal of Glaucoma","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142921877","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-03DOI: 10.1097/IJG.0000000000002534
Mohamed M Khodeiry, Ramsey Yusuf, Christopher A Dorizas, Abdelrahman M Elhusseiny, Mohamed S Sayed, Merry Ruan, Richard K Lee
Purpose: To evaluate the outcomes of slow-coagulation transscleral cyclophotocoagulation (SC-TSCPC) in pseudoexfoliation glaucoma (PXG).
Methods: A single-center, retrospective non-comparative study including consecutive patients with medically uncontrolled PXG who underwent SC-TSCPC (1250-milliwatt power and 4-second duration). The primary outcome measure was surgical success (defined as intraocular pressure (IOP) between 6 - 21 mmHg with ≥20% reduction compared to baseline and no need for further glaucoma surgeries or development of vision-threatening complications). Success was considered qualified when achieved with additional glaucoma medications and complete when achieved without additional glaucoma medications. The secondary outcomes included IOP, glaucoma medication numbers, visual acuity, and postoperative complications at 1 and 2 years after laser treatment.
Results: This study included 48 eyes of 48 patients. The median age of study participants was 87.5 years, with a median follow-up duration of 24.0 months. The qualified success for a single SC-TCPC treatment at 1 and 2 years was 58.3% and 47.9%, respectively. Cumulative qualified success (>1 SC-TSCPC) was 64.6% at 1 year and 56.2% at 2 years. Complete surgical success after a single SC-TSCPC was 45.8% at 1 year and 33.3% at 2 years, increased to 50.0% at 1 year and 39.6% at 2 years after >1 SC-TSCPC. After SC-TSCPC treatment, the mean IOP decreased from 29.2±10.3 mmHg on 3.7±1.0 medications pre-treatment to 14.3±6.43 mmHg on 2.6±1.3 medications at the final follow-up visit (P<0.001). Seven eyes (14.6%) had SC-TSCPC retreatment, and two eyes (4.2%) required incisional glaucoma surgeries. Reported postoperative complications included: decreased visual acuity in 9 (18.8%) eyes, iridocyclitis in 5 (10.4%) eyes, hyphema in 5 (10.4%) eyes, cystoid macular edema in 2 (4.2%) eyes, and transient hypotony in 2 (4.2%) eyes.
Conclusions: SC-TSCPC is an effective, relatively safe, and repeatable surgical treatment option in PXG. Further prospective investigations are suggested to confirm these findings.
{"title":"Slow-Coagulation Transscleral Cyclophotocoagulation in Pseudoexfoliation Glaucoma.","authors":"Mohamed M Khodeiry, Ramsey Yusuf, Christopher A Dorizas, Abdelrahman M Elhusseiny, Mohamed S Sayed, Merry Ruan, Richard K Lee","doi":"10.1097/IJG.0000000000002534","DOIUrl":"https://doi.org/10.1097/IJG.0000000000002534","url":null,"abstract":"<p><strong>Purpose: </strong>To evaluate the outcomes of slow-coagulation transscleral cyclophotocoagulation (SC-TSCPC) in pseudoexfoliation glaucoma (PXG).</p><p><strong>Methods: </strong>A single-center, retrospective non-comparative study including consecutive patients with medically uncontrolled PXG who underwent SC-TSCPC (1250-milliwatt power and 4-second duration). The primary outcome measure was surgical success (defined as intraocular pressure (IOP) between 6 - 21 mmHg with ≥20% reduction compared to baseline and no need for further glaucoma surgeries or development of vision-threatening complications). Success was considered qualified when achieved with additional glaucoma medications and complete when achieved without additional glaucoma medications. The secondary outcomes included IOP, glaucoma medication numbers, visual acuity, and postoperative complications at 1 and 2 years after laser treatment.</p><p><strong>Results: </strong>This study included 48 eyes of 48 patients. The median age of study participants was 87.5 years, with a median follow-up duration of 24.0 months. The qualified success for a single SC-TCPC treatment at 1 and 2 years was 58.3% and 47.9%, respectively. Cumulative qualified success (>1 SC-TSCPC) was 64.6% at 1 year and 56.2% at 2 years. Complete surgical success after a single SC-TSCPC was 45.8% at 1 year and 33.3% at 2 years, increased to 50.0% at 1 year and 39.6% at 2 years after >1 SC-TSCPC. After SC-TSCPC treatment, the mean IOP decreased from 29.2±10.3 mmHg on 3.7±1.0 medications pre-treatment to 14.3±6.43 mmHg on 2.6±1.3 medications at the final follow-up visit (P<0.001). Seven eyes (14.6%) had SC-TSCPC retreatment, and two eyes (4.2%) required incisional glaucoma surgeries. Reported postoperative complications included: decreased visual acuity in 9 (18.8%) eyes, iridocyclitis in 5 (10.4%) eyes, hyphema in 5 (10.4%) eyes, cystoid macular edema in 2 (4.2%) eyes, and transient hypotony in 2 (4.2%) eyes.</p><p><strong>Conclusions: </strong>SC-TSCPC is an effective, relatively safe, and repeatable surgical treatment option in PXG. Further prospective investigations are suggested to confirm these findings.</p>","PeriodicalId":15938,"journal":{"name":"Journal of Glaucoma","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142921892","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}