Ophthalmology. Glaucoma最新文献

Purpose: To compare the 12-month outcomes of cataract surgery combined with iStent Inject W or Kahook Dual Blade Glide versus cataract surgery alone.

Design: Prospective, randomized controlled trial conducted at a single center in Sweden.

Participants: Adult patients with cataract and medically treated ocular hypertension or mild to advanced primary open-angle glaucoma or pseudoexfoliative glaucoma.

Methods: Patients were randomized 1:1:1 to cataract surgery with iStent Inject W (cataract-iStent group, n = 40), cataract surgery with Kahook Dual Blade Glide (cataract-KDB group, n = 40), or cataract surgery alone (cataract group, n = 40), and followed for 12 months.

Main outcome measures: The primary effectiveness end points were surgical success, defined as a reduction in intraocular pressure (IOP) of ≥ 20% and/or a reduction of ≥ 1 medication, and change in IOP and ocular hypotensive medications at 12 months. Secondary endpoints included threshold IOP levels and adverse events.

Results: At 12 months, the rate of surgical success was higher in the cataract-iStent and cataract-KDB groups compared to the cataract group (87.5% vs 52.5%, P < 0.001). Mean reduction in IOP was similar between groups (-3.0, -3.5 and -2.8 mmHg, P = 0.755), while reduction in medication was higher in the cataract-iStent and cataract-KDB groups compared to the cataract group (-0.8 and -0.9 vs -0.4, P = 0.01). The main adverse events were transient hyphema (15% in the cataract-KDB group) and IOP spikes (37.5% in the cataract group, 10% in the cataract-iStent group, and 15% in the cataract-KDB group, P = 0.006). Additional glaucoma surgery was required in 1 eye (in the cataract group) and added therapy or selective laser trabeculoplasty in 4 eyes (3 in the cataract group and 1 in the cataract-KDB group).

Conclusions: Combined cataract surgery with iStent Inject W or Kahook Dual Blade Glide achieved significantly greater surgical success compared to cataract surgery alone, and this was due to a greater reduction in number of hypotensive medications.

Purpose: To evaluate the long-term efficacy and safety profile of nonvalved glaucoma drainage devices (GDDs) in the management of refractory uveitic glaucoma.

Design: Retrospective interventional case series.

Participants: Sixty-five eyes of 51 patients.

Methods: Patients underwent Baerveldt (78.5%) or Molteno (21.5%) GDD implantation at a single tertiary center between 2000 and 2021. The mean follow-up period was 12.05 ± 4.9 years.

Main outcome measures: Primary outcome was surgical success defined by World Glaucoma Association criteria. Secondary outcomes included intraocular pressure (IOP) control, medication burden, and complications.

Results: Mean IOP decreased from 32.6 ± 8.4 mmHg preoperatively to 12.2 ± 5.2 mmHg at the last follow-up (P < 0.0001), with concurrent glaucoma medications reduction from 3.8 ± 0.8 to 0.9 ± 1.1 (P < 0.0001). At the final visit, qualified and complete success rates were 58.5% (38/65) and 33.8% (22/65), respectively. The mean survival time was 12.8 years for qualified success and 8.1 years for complete success. Failure occurred in 41.5% (27/65) of eyes, most commonly due to hypotony (13 eyes) or inadequate IOP reduction (10 eyes). Mean best-corrected visual acuity was unchanged (0.49 ± 0.53 vs 0.59 ± 0.72 logarithm of the minimum angle of resolution, P = 0.34). On multivariate analysis, Baerveldt implantation (hazard ratio [HR], 5.56; 95% confidence interval [CI], 2.20-14.09; P < 0.001) and concurrent systemic biologic therapy (HR, 28.57; 95% CI, 6.90-111.11; P < 0.001) were strong independent predictors of qualified success.

Conclusions: Nonvalved GDDs offer durable IOP control and preserved vision in uveitic glaucoma, for over a decade, with 58.5% qualified success and 41.5% failure at final follow-up (12.05 ± 4.9 years). These findings represent the longest reported outcomes for this cohort.

Financial disclosure(s): The authors have no proprietary or commercial interest in any materials discussed in this article.

Purpose: To evaluate the 24-month safety and efficacy of phacoemulsification combined with ab interno Tanito microhook trabeculotomy (microLOT) compared with phacoemulsification alone in patients with open-angle glaucoma (OAG) and cataract.

Design: Prospective, randomized, interventional clinical trial.

Participants: Patients with mild-to-moderate OAG and visually significant cataract.

Methods: One hundred fourteen eyes of 114 patients were randomized to phacoemulsification and microLOT (Phaco-microLOT) (n = 57) or phacoemulsification alone (n = 57).

Main outcome measures: Intraocular pressure (IOP), antiglaucoma medication (AGM) burden, best-corrected visual acuity, surgical success, and complications were assessed through 24 months. Success was defined as a combination of at least 20%, 25%, or 30% reduction in IOP and an absolute IOP of less than 21, 18, or 15 mmHg, respectively (criteria 1, 2, and 3).

Results: At 24 months, 99 patients out of the original cohort of 114 patients were analyzed (group 1 = 50; group 2 = 49). The mean IOP decreased from 26.5 ± 5.2 to 15.2 ± 4.9 mmHg in the Phaco-microLOT group and from 25.3 ± 3.1 to 18.2 ± 2.8 mmHg in the phaco-alone group (P < 0.001). The percentage IOP reduction was significantly greater in group 1 (42.6% vs. 28.1%, P = 0.004). In group 1, the mean (standard deviation) AGM used preoperatively was 0.6 (0.9), which significantly decreased to 0.2 (0.4) at 24 months, whereas in group 2, it marginally increased from 1.4 (0.6) to 1.5 (0.9). Overall success (complete + qualified) in group 1 using criteria 1, 2, and 3 was 83.3%, 72.9%, and 43.8%, whereas in group 2 it was 57.8%, 40%, and 20%, respectively. The risk of failure in group 2 was 2.87 times higher. No additional complications were observed, and no interventions were required between 12 and 24 months of follow-up.

Conclusions: Phacoemulsification and microLOT achieved sustained and superior IOP and medication reduction at 24 months, with a favorable safety profile compared to the phacoemulsification alone group. These results underscore the long-term role of microLOT for OAG.

Financial disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Purpose: To evaluate the effect of oral melatonin administration in patients with advanced glaucoma on sleep-wake cycle variables recorded by actigraphy on a single night and sleep quality assessed by specific questionnaires.

Design: Prospective, randomized, parallel, crossover, double-masked therapeutic-type.

Participants: Sixty-four patients aged between 40 and 80 years, diagnosed with advanced primary open-angle glaucoma, were included.

Methods: Participants received 5 mg of melatonin or placebo daily for 30 days, 1-week washout period; all assessments were repeated after each treatment phase. Subjective sleep was evaluated using the Pittsburgh Sleep Quality Index (PSQI) and the Epworth Sleepiness Scale (ESS). Objective sleep parameters total sleep time (TST), wake after sleep onset (WASO), number of awakenings, and sleep efficiency (SE) were measured by actigraphy. Vision-related quality of life was assessed using the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25). Standardized ophthalmologic exams, visual field testing (Swedish Interactive Threshold Algorithm Standard 24-2), and OCT-based retinal nerve fiber layer analysis were also performed.

Main outcome measures: The primary outcomes were PSQI and actigraphy-measured SE. The secondary outcomes included TST, WASO, number of awakenings, ESS, and NEI VFQ-25 scores.

Results: All 64 participants completed the study. No significant differences were found between melatonin and placebo for any sleep or quality of life outcomes. However, both groups showed improvements over time: PSQI scores decreased (-1.36 points; P < 0.001) and NEI VFQ-25 scores increased (+3.09 points; P < 0.001), indicating a temporal effect. Poor sleep quality (PSQI > 5) and reduced SE were associated with worse objective sleep parameters and lower vision-related quality of life. No carryover or sequence effects were observed, and melatonin did not significantly impact actigraphy measures such as TST, WASO, or number of awakenings.

Conclusions: Melatonin supplementation did not significantly improve sleep quality compared to a placebo in patients with advanced glaucoma, based on both subjective and objective measures. The improvements observed in the sleep questionnaires during the treatment phases suggest that patient perception may play a significant role in sleep-related outcomes, underscoring the importance of considering placebo effects in clinical trials.

Financial disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Purpose: To compare the outcomes of primary combined trabeculotomy with trabeculectomy (CTT) in children diagnosed with early-onset glaucoma associated with phacomatosis pigmentovascularis (PPV) and Sturge-Weber syndrome (SWS).

Design: Retrospective cohort study.

Participants: Forty-seven eyes (47 children) with SWS and 48 eyes (31 children) with PPV, who underwent primary CTT with a minimum follow-up of 1 year between 1996 and 2020 were included.

Methods: Preoperative and postoperative data were collected. Surgical success rates were estimated using Kaplan-Meier survival analysis, whereas comparisons between the groups were performed using mixed-effects Weibull proportional hazards models accounting for intrapatient correlation in bilateral cases. Risk factors for failure were assessed with multivariable models incorporating the same adjustment.

Main outcome measures: Intraocular pressure (IOP) control, complete and qualified success, need for additional medications, postoperative complications in 2 groups.

Results: Preoperative ocular characteristics were comparable between the groups, except that PPV cases were more often bilateral. Neurological abnormalities, including epilepsy (P < 0.001) and central nervous system anomalies (P = 0.04), were more common in PPV. The median follow-up was 7 years in the PPV group and 6.5 years in the SWS group. At the final follow-up period, the IOP reduced significantly in both groups when compared with the preoperative values (P < 0.001). Complete success was higher in the the SWS group (60%) than in PPV (40%), though not statistically significant (P = 0.15). Qualified success was similar in both groups (P = 0.79). However, the PPV group required significantly more glaucoma medications (P = 0.03) to maintain the IOP. Older age at the time of surgery (P < 0.001), and higher grade of corneal haze at baseline (P = 0.03) were associated with failure (according to complete success criteria) in the PPV group. Although the overall rate of postoperative complications was similar (P = 0.98), sight-threatening complications were more frequent in the PPV group.

Conclusions: Primary CTT achieved good long-term IOP control in both the PPV and SWS groups. The PPV group exhibited a higher prevalence of neurological and systemic associations and a greater need for postoperative medications, indicating a more complex disease course. Early surgical intervention and close postoperative monitoring are essential to achieving optimal outcomes in these challenging phakomatoses.

Financial disclosure(s): The authors have no proprietary or commercial interest in any materials discussed in this article.

Purpose: To compare efficacy and safety outcomes of phacoemulsification combined with either iStent inject W or OMNI surgical system with different degrees of gonioscopy-assisted transluminal trabeculotomy (GATT) in patients with glaucoma.

Design: Single-center, retrospective, nonrandomized comparative cohort study.

Subjects: Consecutive cases that underwent phacoemulsification combined with either iStent inject W or OMNI surgical system with at least 12-month follow-up.

Methods: Single-center retrospective comparative cohort study comparing outcomes between 3 groups: phacoemulsification with iStent inject W (phaco-iStent) or OMNI with either 90° to 180° (phaco-OG [OMNI and GATT]180) or >180° to 360° (phaco-OG360) of GATT.

Main outcome measures: Success at 12 months is defined as medication-free with either a 20% intraocular pressure (IOP) reduction or IOP ≤18 mmHg. Primary outcomes were IOP and the number of glaucoma medications. Secondary outcomes included complications and the need for further glaucoma surgery.

Results: A total of 294 eyes (phaco-iStent, 135; phaco-OG180, 39; phaco-OG360, 120) of 250 patients were included with similar baseline IOP (18 mmHg, P = 0.91) and medications (2.04 vs. 1.67 vs. 2.01, P = 0.22) across groups. Significant reductions in IOP and number of glaucoma medications were observed across all 3 groups (P < 0.0014), although no significant differences were found between procedures for any outcome measure. Success rates were 25.2%, 38.5%, and 32.5%, whereas medication-free rates were 28.1%, 38.5%, and 35.0% for the phaco-iStent, phaco-OG180, and phaco-OG360 groups, respectively, without significant differences. Phaco-OG360 achieved significantly higher rates of medication-free IOP reductions of ≥30% compared with phaco-iStent (P = 0.013) in exploratory analysis. Complications were more frequent in the phaco-OG180 and phaco-OG360 groups compared with the phaco-iStent group, with higher rates of microhyphema (5.1% and 10.8% vs. 0.7%) and layered hyphema (12.8% and 4.2% vs. 0.7%), respectively. One eye in the phaco-OG360 group underwent a trabeculectomy at 6 months.

Conclusions: All procedures significantly reduced IOP and medication burden, with no significant difference in overall success rates. Phaco-iStent has a better safety profile, although phaco-OMNI may provide higher rates of medication-free IOP reduction. Outcomes between 180° and 360° of GATT were similar, suggesting limited additional benefit from extending trabeculotomy. These findings may help guide decision-making in combined phacoemulsification and canal-based minimally invasive glaucoma surgery.

Financial disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Purpose: In a study using US nationwide claims data from 2008 to 2017, the median time between visual field tests for patients with glaucoma was once every 1.59 years (interquartile range: 1.14-3.03 years). This is less frequent than the American Academy of Ophthalmology (AAO)-recommended minimum annual screening. We conducted simulation modeling using clinical data to determine how long it would take to identify trend-based glaucoma visual field progression at this testing frequency and compare it to AAO-recommended annual screening.

Design: Simulation modeling using retrospective clinical data.

Subjects: Patients with glaucoma in the Duke Glaucoma Registry (DGR).

Methods: To determine how long it would take to identify glaucoma progression at testing frequencies in this insured US nationwide population, we conducted simulation modeling using clinical visual field data from the DGR. Models were created to evaluate the time it would take to identify progression for patients with testing frequency at the 25th, 50th, and 75th percentiles in the previously published US nationwide claims data and at the AAO-recommended minimum annual screening. The simulations assumed baseline mean deviation (MD) of -5, -10, or -15 decibels (dB) and a true rate of progression of -0.5 or -1.0 dB/year. Progression was defined as having a negative MD slope estimate with a P value <0.05. We simulated 1000 sequences of visual fields for each test group.

Main outcome measures: Time to detect glaucoma progression RESULTS: Across the testing scenarios, the time to detect progression in 80% of eyes ranged from 15.2 to 24.3 years for patients receiving visual field testing at the 25th percentile (3.03 years between tests), 9.6 to 17.5 years for patients receiving visual field testing at the 50th percentile (1.59 years between tests), 8.0 to 14.9 years for patients receiving visual field testing at the 75th percentile (1.14 years between tests), and 7.1 to 14.1 years for patients receiving annual testing.

Conclusions: These results suggest that either visual field testing needs to be done more frequently or other methods of identification of progressive glaucoma vision loss need to be developed. Clinical decision support systems could help tailor the frequency of visual field testing to the needs of individual patients.

Financial disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Objective: We sought to identify areas of consensus and nonconsensus in the ophthalmic screening, diagnosis, and management of Sturge-Weber syndrome (SWS).

Design: Modified Delphi methodology.

Participants: North American glaucoma experts with prior experience managing glaucoma in patients with Sturge-Weber syndrome.

Methods: A modified Delphi process was used as a systematic and structured communication technique, consisting of 2 rounds of electronic questionnaires to a wider group, followed by an in-person meeting of selected experts. Questions that did not reach agreement were reformulated in each round, with the aim of reaching consensus. The University of Rochester Research Subject Review Board noted that this study was exempt from IRB approval. This study adhered to the Declaration of Helsinki.

Main outcome measures: Consensus was defined as agreement among at least 85% of participants for the electronic questionnaires or a minimum of 70% during the in-person meeting.

Results: Among other recommendations, the panel concluded that all patients with a facial port wine birthmark should be assessed for glaucoma within a month of birth, with shorter screening intervals thereafter in patients with bilateral eyelid involvement, choroidal hemangioma, and signs of elevated episcleral venous pressure. There was no consensus on timing of follow-up visits. In children aged ≥4 years with signs of glaucoma, medical intervention is the initial consideration. In children aged <4 years, the primary intervention is likely to be surgical, with some form of goniosurgery as the first-choice procedure.

Conclusions: Consensus for screening, diagnosis, and management in patients with SWS is designed to hopefully improve clinical practice and patient outcomes. Questions where consensus was not reached may highlight variations in practice, conflicting evidence, or areas that might benefit from further research and investigation.

Financial disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.