Pub Date : 2025-01-01DOI: 10.1016/j.ophtha.2024.09.010
Jay S. Pepose MD, PhD , David Wirta MD , David Evans OD , Barbara Withers PhD , Kavon Rahmani BS , Audrey Lazar BS , Drey Coleman BS , Ronil Patel MS , Reda Jaber MD , Mina Sooch MBA , Mitchell Brigell PhD , Konstantinos Charizanis PhD
Purpose
To evaluate the safety and efficacy of 0.75% phentolamine ophthalmic solution (POS), an α-adrenergic antagonist, in reversal of pharmacologically induced mydriasis.
Design
Two phase 3, multicenter, placebo-controlled, randomized, double-masked clinical trials in healthy participants.
Participants
Five hundred fifty-three healthy 12- to 80-year-old participants were randomized 1:1 (MIRA 2) and 2:1 (MIRA 3) to receive either POS or placebo eye drops in both eyes.
Methods
Participants received POS or placebo administered 1 hour after mydriasis, induced by instillation of either 2.5% phenylephrine, 1% tropicamide, or 1% hydroxyamphetamine / 0.25% tropicamide.
Main Outcome Measures
Percent of participants returning to within 0.2 mm of baseline pupil diameter in study eye 90 minutes after POS administration. Safety measures included treatment-emergent adverse events and tolerability measures, including conjunctival hyperemia.
Results
A total of 553 participants were randomized to treatment with placebo (n = 215) or POS (n = 338). A statistically significant greater percentage of participants treated with POS showed reversal of mydriasis at 90 minutes compared to placebo (MIRA 2: 48.9% vs. 6.6% [P < 0.0001]; MIRA 3: 58% vs. 6% [P < 0.0001]) and as early as 60 minutes (MIRA 2: 27.7% vs. 2.2% [P < 0.0001]; MIRA 3: 42% vs. 2% [P < 0.0001]). Between 28% and 34% of participants receiving placebo did not returned to baseline PD at 24 hours after pharmacologic dilation compared with 8% to 11% of patients treated with POS (P < 0.0001).
Conclusions
Treatment with POS reduced PD within 60 to 90 minutes, with a statistically significant time savings of 5 to 6 hours to return to baseline PD compared with placebo. One or 2 drops of POS rapidly reversed mydriasis in all participants regardless of mydriatic agent or iris color. More participants receiving POS reported a benefit in the resolution of visual symptoms caused by pharmacologically induced mydriasis compared with placebo, with statistically significant differences noted as early as 1 hour. The safety profile was favorable, with the most common adverse effects being mild transient conjunctival hyperemia (11.2%), instillation site discomfort (10.9%), and dysgeusia (3.6%).
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
{"title":"Reversal of Pharmacologically Induced Mydriasis with Phentolamine Ophthalmic Solution","authors":"Jay S. Pepose MD, PhD , David Wirta MD , David Evans OD , Barbara Withers PhD , Kavon Rahmani BS , Audrey Lazar BS , Drey Coleman BS , Ronil Patel MS , Reda Jaber MD , Mina Sooch MBA , Mitchell Brigell PhD , Konstantinos Charizanis PhD","doi":"10.1016/j.ophtha.2024.09.010","DOIUrl":"10.1016/j.ophtha.2024.09.010","url":null,"abstract":"<div><h3>Purpose</h3><div>To evaluate the safety and efficacy of 0.75% phentolamine ophthalmic solution (POS), an α-adrenergic antagonist, in reversal of pharmacologically induced mydriasis.</div></div><div><h3>Design</h3><div>Two phase 3, multicenter, placebo-controlled, randomized, double-masked clinical trials in healthy participants.</div></div><div><h3>Participants</h3><div>Five hundred fifty-three healthy 12- to 80-year-old participants were randomized 1:1 (MIRA 2) and 2:1 (MIRA 3) to receive either POS or placebo eye drops in both eyes.</div></div><div><h3>Methods</h3><div>Participants received POS or placebo administered 1 hour after mydriasis, induced by instillation of either 2.5% phenylephrine, 1% tropicamide, or 1% hydroxyamphetamine / 0.25% tropicamide.</div></div><div><h3>Main Outcome Measures</h3><div>Percent of participants returning to within 0.2 mm of baseline pupil diameter in study eye 90 minutes after POS administration. Safety measures included treatment-emergent adverse events and tolerability measures, including conjunctival hyperemia.</div></div><div><h3>Results</h3><div>A total of 553 participants were randomized to treatment with placebo (n = 215) or POS (n = 338). A statistically significant greater percentage of participants treated with POS showed reversal of mydriasis at 90 minutes compared to placebo (MIRA 2: 48.9% vs. 6.6% [<em>P</em> < 0.0001]; MIRA 3: 58% vs. 6% [<em>P</em> < 0.0001]) and as early as 60 minutes (MIRA 2: 27.7% vs. 2.2% [<em>P <</em> 0.0001]; MIRA 3: 42% vs. 2% [<em>P</em> < 0.0001]). Between 28% and 34% of participants receiving placebo did not returned to baseline PD at 24 hours after pharmacologic dilation compared with 8% to 11% of patients treated with POS (<em>P</em> < 0.0001).</div></div><div><h3>Conclusions</h3><div>Treatment with POS reduced PD within 60 to 90 minutes, with a statistically significant time savings of 5 to 6 hours to return to baseline PD compared with placebo. One or 2 drops of POS rapidly reversed mydriasis in all participants regardless of mydriatic agent or iris color. More participants receiving POS reported a benefit in the resolution of visual symptoms caused by pharmacologically induced mydriasis compared with placebo, with statistically significant differences noted as early as 1 hour. The safety profile was favorable, with the most common adverse effects being mild transient conjunctival hyperemia (11.2%), instillation site discomfort (10.9%), and dysgeusia (3.6%).</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":19533,"journal":{"name":"Ophthalmology","volume":"132 1","pages":"Pages 79-91"},"PeriodicalIF":13.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142292785","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01DOI: 10.1016/j.ophtha.2024.07.008
Jee Myung Yang MD, PhD , Se Yong Jung MD , Min Seo Kim MD , Seung Won Lee MD, PhD , Dong Keon Yon MD , Jae Il Shin MD, PhD , Joo Yong Lee MD, PhD
<div><h3>Purpose</h3><div>To analyze cardiovascular and cerebrovascular adverse drug reactions (ADRs) after intravitreal anti–VEGF (aflibercept, bevacizumab, brolucizumab, and ranibizumab) treatment.</div></div><div><h3>Participants</h3><div>VigiBase, a World Health Organization (WHO) global safety report database.</div></div><div><h3>Design</h3><div>Pharmacovigilance study.</div></div><div><h3>Methods</h3><div>The individual case safety reports (ICSRs) of cardiovascular and cerebrovascular ADRs after intravitreal anti-VEGF treatment were compared with those reported in the full database. From 2004 to 2023, there were 23 129 ADRs after intravitreal anti-VEGF therapy and 25 015 132 ADRs associated with any drug (full database).</div></div><div><h3>Main Outcome Measures</h3><div>The reporting odds ratio (ROR) and information components (ICs) were calculated, and the 95% lower credibility interval end point of the information component (IC<sub>025</sub>) was used for disproportionate Bayesian reporting. Inter-drug comparisons were performed using the ratio of odds ratio (rOR).</div></div><div><h3>Results</h3><div>Compared with the full database, anti-VEGFs were associated with an increased reporting of myocardial infarction (IC<sub>025</sub> 0.75; ROR: 1.78 [95% CI, 1.70–1.86]), angina pectoris (IC<sub>025</sub> 0.53; ROR: 1.61 [95% CI, 1.47–1.77]), arrhythmias including atrial fibrillation, atrial flutter, ventricular fibrillation, supraventricular tachycardia (all IC<sub>025</sub> > 0, ROR>1), hypertension (IC<sub>025</sub> 2.22; ROR: 4.91 [95% CI, 4.82–5.01]), and hypertensive crisis (IC<sub>025</sub> 1.97; ROR: 4.49 [95% CI, 4.07–4.97]). Moreover, anti-VEGFs were associated with a higher reporting of cerebrovascular ADRs such as cerebral infarction (IC<sub>025</sub> 4.34; ROR: 23.19 [95% CI, 22.10–24.34]), carotid artery stenosis (IC<sub>025</sub> 1.85; ROR: 5.24 [95% CI, 3.98–6.89]), cerebral hemorrhage (IC<sub>025</sub> 2.29; ROR: 5.38 [95% CI, 5.03–5.76]), and subarachnoid hemorrhage (IC<sub>025</sub> 1.98; ROR: 4.81 [95% CI, 4.14–5.6]). Inter-drug comparison indicated that compared with ranibizumab, patients receiving aflibercept showed overall under-reporting of cardiovascular and cerebrovascular ADRs such as myocardial infarction (rOR 0.55 [95% CI, 0.49–0.52]), atrial fibrillation (rOR 0.28 [95% CI, 0.23–0.35]), cerebrovascular accident (rOR, 0.15 [95% CI, 0.14–0.17]), and cerebral hemorrhage (rOR, 0.51 [95% CI, 0.40–0.65]).</div></div><div><h3>Conclusions</h3><div>In this pharmacovigilance case-noncase study, there was significantly increased reporting of cardiovascular and cerebrovascular ADRs after intravitreal anti-VEGF treatment. Although ranibizumab may exhibit superior systemic safety regarding its biological characteristics, it is crucial not to overlook the occurrence of cardiovascular and cerebrovascular ADRs considering its higher reporting rate than bevacizumab or aflibercept.</div></div><div><h3>Financial Disclosure(s)</
目的:分析玻璃体内抗血管内皮生长因子(VEGF;aflibercept、贝伐单抗、brolucizumab和ranibizumab)治疗后的心脑血管不良事件(ADRs):世界卫生组织(WHO)全球安全报告数据库 VigiBase 设计:药物警戒研究 方法:将玻璃体内抗血管内皮生长因子治疗后心脑血管 ADR 的单个病例安全报告(ICSR)与完整数据库中的报告进行比较。从 2004 年到 2023 年,玻璃体内抗 VEGF 治疗后的 ADR 为 23,129 例,与任何药物相关的 ADR 为 25,015,132 例(完整数据库):计算报告几率(ROR)和信息成分(IC),并使用信息成分的 95% 可信区间下限(IC025)进行贝叶斯不对称报告。使用奇异比(rOR)进行药物间比较:77])、心律失常,包括心房颤动、心房扑动、心室颤动、室上性心动过速(IC025 均>0,ROR>1)、高血压(IC025 2.22;ROR:4.91 [95% CI 4.82-5.01])和高血压危象(IC025 1.97;ROR:4.49 [95% CI 4.07-4.97])。此外,抗血管内皮生长因子与较高的脑血管 ADR 相关,如脑梗塞(IC025 4.34;ROR:23.19 [95% CI 22.10-24.34])、颈动脉狭窄(IC025 1.85;ROR:5.24 [95% CI 3.98-6.89])、脑出血(IC025 2.29;ROR:5.38 [95% CI 5.03-5.76])和蛛网膜下腔出血(IC025 1.98;ROR:4.81 [95% CI 4.14-5.6])。药物间比较显示,与雷尼珠单抗相比,使用阿夫利百普的患者在心肌梗死等心脑血管 ADRs 方面总体报告不足(rOR 0.55 [95% CI 0.49-0.52])、心房颤动(rOR 0.28 [95% CI 0.23-0.35])、脑血管意外(rOR,0.15 [95% CI 0.14-0.17])和脑出血(rOR,0.51 [95% CI 0.40-0.65]):在这项药物警戒病例-非病例研究中,发现玻璃体内抗血管内皮生长因子治疗后心血管和脑血管不良反应的报告显著增加。虽然雷尼珠单抗的生物特性可能显示出更高的全身安全性,但考虑到其报告率高于贝伐珠单抗或阿弗利贝赛普,因此不应忽视心脑血管不良反应的发生。
{"title":"Cardiovascular and Cerebrovascular Adverse Events Associated with Intravitreal Anti-VEGF Monoclonal Antibodies","authors":"Jee Myung Yang MD, PhD , Se Yong Jung MD , Min Seo Kim MD , Seung Won Lee MD, PhD , Dong Keon Yon MD , Jae Il Shin MD, PhD , Joo Yong Lee MD, PhD","doi":"10.1016/j.ophtha.2024.07.008","DOIUrl":"10.1016/j.ophtha.2024.07.008","url":null,"abstract":"<div><h3>Purpose</h3><div>To analyze cardiovascular and cerebrovascular adverse drug reactions (ADRs) after intravitreal anti–VEGF (aflibercept, bevacizumab, brolucizumab, and ranibizumab) treatment.</div></div><div><h3>Participants</h3><div>VigiBase, a World Health Organization (WHO) global safety report database.</div></div><div><h3>Design</h3><div>Pharmacovigilance study.</div></div><div><h3>Methods</h3><div>The individual case safety reports (ICSRs) of cardiovascular and cerebrovascular ADRs after intravitreal anti-VEGF treatment were compared with those reported in the full database. From 2004 to 2023, there were 23 129 ADRs after intravitreal anti-VEGF therapy and 25 015 132 ADRs associated with any drug (full database).</div></div><div><h3>Main Outcome Measures</h3><div>The reporting odds ratio (ROR) and information components (ICs) were calculated, and the 95% lower credibility interval end point of the information component (IC<sub>025</sub>) was used for disproportionate Bayesian reporting. Inter-drug comparisons were performed using the ratio of odds ratio (rOR).</div></div><div><h3>Results</h3><div>Compared with the full database, anti-VEGFs were associated with an increased reporting of myocardial infarction (IC<sub>025</sub> 0.75; ROR: 1.78 [95% CI, 1.70–1.86]), angina pectoris (IC<sub>025</sub> 0.53; ROR: 1.61 [95% CI, 1.47–1.77]), arrhythmias including atrial fibrillation, atrial flutter, ventricular fibrillation, supraventricular tachycardia (all IC<sub>025</sub> > 0, ROR>1), hypertension (IC<sub>025</sub> 2.22; ROR: 4.91 [95% CI, 4.82–5.01]), and hypertensive crisis (IC<sub>025</sub> 1.97; ROR: 4.49 [95% CI, 4.07–4.97]). Moreover, anti-VEGFs were associated with a higher reporting of cerebrovascular ADRs such as cerebral infarction (IC<sub>025</sub> 4.34; ROR: 23.19 [95% CI, 22.10–24.34]), carotid artery stenosis (IC<sub>025</sub> 1.85; ROR: 5.24 [95% CI, 3.98–6.89]), cerebral hemorrhage (IC<sub>025</sub> 2.29; ROR: 5.38 [95% CI, 5.03–5.76]), and subarachnoid hemorrhage (IC<sub>025</sub> 1.98; ROR: 4.81 [95% CI, 4.14–5.6]). Inter-drug comparison indicated that compared with ranibizumab, patients receiving aflibercept showed overall under-reporting of cardiovascular and cerebrovascular ADRs such as myocardial infarction (rOR 0.55 [95% CI, 0.49–0.52]), atrial fibrillation (rOR 0.28 [95% CI, 0.23–0.35]), cerebrovascular accident (rOR, 0.15 [95% CI, 0.14–0.17]), and cerebral hemorrhage (rOR, 0.51 [95% CI, 0.40–0.65]).</div></div><div><h3>Conclusions</h3><div>In this pharmacovigilance case-noncase study, there was significantly increased reporting of cardiovascular and cerebrovascular ADRs after intravitreal anti-VEGF treatment. Although ranibizumab may exhibit superior systemic safety regarding its biological characteristics, it is crucial not to overlook the occurrence of cardiovascular and cerebrovascular ADRs considering its higher reporting rate than bevacizumab or aflibercept.</div></div><div><h3>Financial Disclosure(s)</","PeriodicalId":19533,"journal":{"name":"Ophthalmology","volume":"132 1","pages":"Pages 62-78"},"PeriodicalIF":13.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141616948","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01DOI: 10.1016/j.ophtha.2024.07.018
Shoaib Ugradar MD , Emanuil Parunakian BS , Emil Malkhasyan BS , Carolina A. Chiou MD , Hannah L. Walsh BS , Joseph Tolentino BS , Sara T. Wester MD , Suzanne K. Freitag MD , Raymond S. Douglas MD, PhD
Purpose
To determine the rate of re-treatment in patients who receive a full course of teprotumumab therapy for thyroid eye disease (TED) and drivers of re-treatment.
Design
Multicenter retrospective study.
Participants
All patients who received a full course of treatment and had available data at 1 year after initial treatment were included.
Methods
Charts were reviewed for the following information: age, sex, months since diagnosis of TED, smoking status, and prior treatments. Further, the clinical activity score (CAS), proptosis, and the Gorman diplopia score were reviewed at baseline, at the end of the first course, and at baseline for the second course in those who received it. A logistic regression model was created to review the drivers of re-treatment.
Main Outcome Measures
Rate of re-treatment and the drivers of re-treatment.
Results
One hundred nineteen patients were included from 3 centers across the United States. The overall re-treatment rate was 24% (29/119). No difference was found among the 3 sites (P = 0.6). In univariable analyses, at baseline, no difference was found in proptosis (P = 0.07), diplopia score (P = 0.4), or duration of TED (P = 0.4) between patients who were re-treated and those not re-treated. From the re-treated group, 82% showed a significant proptosis response (≥ 2-mm reduction from baseline) after the initial course, whereas 68% of patients who were not re-treated showed a clinically significant proptosis response (P = 0.16). The mean ± standard deviation difference between the end of the first treatment and at baseline before the second treatment (in those who received it) was 2 ± 2 for CAS, 2 ± 4 mm for proptosis, and 1 ± 1 for diplopia score. Age was the only significant driver of re-treatment (P < 0.05). Re-treated patients were 7 years older than patients who were not re-treated (60 years vs. 53 years; P < 0.05).
Conclusions
In patients receiving a full course of teprotumumab therapy, the rate of re-treatment was 24%. Age was the only driver of re-treatment.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
{"title":"The Rate of Re-treatment in Patients Treated with Teprotumumab","authors":"Shoaib Ugradar MD , Emanuil Parunakian BS , Emil Malkhasyan BS , Carolina A. Chiou MD , Hannah L. Walsh BS , Joseph Tolentino BS , Sara T. Wester MD , Suzanne K. Freitag MD , Raymond S. Douglas MD, PhD","doi":"10.1016/j.ophtha.2024.07.018","DOIUrl":"10.1016/j.ophtha.2024.07.018","url":null,"abstract":"<div><h3>Purpose</h3><div>To determine the rate of re-treatment in patients who receive a full course of teprotumumab therapy for thyroid eye disease (TED) and drivers of re-treatment.</div></div><div><h3>Design</h3><div>Multicenter retrospective study.</div></div><div><h3>Participants</h3><div>All patients who received a full course of treatment and had available data at 1 year after initial treatment were included.</div></div><div><h3>Methods</h3><div>Charts were reviewed for the following information: age, sex, months since diagnosis of TED, smoking status, and prior treatments. Further, the clinical activity score (CAS), proptosis, and the Gorman diplopia score were reviewed at baseline, at the end of the first course, and at baseline for the second course in those who received it. A logistic regression model was created to review the drivers of re-treatment.</div></div><div><h3>Main Outcome Measures</h3><div>Rate of re-treatment and the drivers of re-treatment.</div></div><div><h3>Results</h3><div>One hundred nineteen patients were included from 3 centers across the United States. The overall re-treatment rate was 24% (29/119). No difference was found among the 3 sites (<em>P</em> = 0.6). In univariable analyses, at baseline, no difference was found in proptosis (<em>P</em> = 0.07), diplopia score (<em>P</em> = 0.4), or duration of TED (<em>P</em> = 0.4) between patients who were re-treated and those not re-treated. From the re-treated group, 82% showed a significant proptosis response (≥ 2-mm reduction from baseline) after the initial course, whereas 68% of patients who were not re-treated showed a clinically significant proptosis response (<em>P</em> = 0.16). The mean ± standard deviation difference between the end of the first treatment and at baseline before the second treatment (in those who received it) was 2 ± 2 for CAS, 2 ± 4 mm for proptosis, and 1 ± 1 for diplopia score. Age was the only significant driver of re-treatment (<em>P</em> < 0.05). Re-treated patients were 7 years older than patients who were not re-treated (60 years vs. 53 years; <em>P</em> < 0.05).</div></div><div><h3>Conclusions</h3><div>In patients receiving a full course of teprotumumab therapy, the rate of re-treatment was 24%. Age was the only driver of re-treatment.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":19533,"journal":{"name":"Ophthalmology","volume":"132 1","pages":"Pages 92-97"},"PeriodicalIF":13.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141734751","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01DOI: 10.1016/j.ophtha.2024.07.026
Richard Donkor MSc, PhD, Alessandro A. Jammal MD, PhD, David S. Greenfield MD
Purpose
To examine the relationship between systemic arterial blood pressure (BP) and the rate of change in standard automated perimetry (SAP) in eyes with glaucoma and suspected glaucoma.
Design
Prospective cohort study.
Participants
One hundred twenty-four eyes (91 eyes with glaucoma, 33 eyes with suspected glaucoma) of 64 patients (mean age, 68.4 ± 7.6 years) followed up at the Bascom Palmer Eye Institute, Palm Beach Gardens, Florida.
Methods
Participants underwent ophthalmic examination, BP measurement, and SAP at 4-month intervals. At the baseline visit, 24-hour ambulatory blood pressure monitoring (ABPM) was acquired. Linear mixed models (adjusted for inclusion of both eyes, age, sex, race, intraocular pressure, baseline severity, and central corneal thickness) were used to investigate the effect of BP on the rates of SAP mean deviation (MD) change over time.
Main Outcome Measures
Effect of baseline 24-hour and follow-up mean arterial pressure (MAP), systolic BP (SBP), and diastolic BP on change in SAP MD.
Results
Eyes underwent an average of 8.9 ± 1.5 SAP examinations over 28.3 ± 6.0 months of follow-up. The median rate of MD change was 0.14 dB/year (range, –1.21 to 0.96 dB/year) with 9 eyes (7%) showing moderate to fast progression (MD change, ≤ –0.50 dB/year). Each 10 mmHg lower in 24-hour average MAP and SBP were associated with –0.171 dB/year (P = 0.045) and –0.137 dB/year (P = 0.023) faster rates of MD loss. Lower mean SBP during follow-up was associated significantly (P = 0.003) with MD progression.
Conclusions
Lower baseline 24-hour ABPM measurements, as well as low SBP during follow-up, were associated significantly with faster rates of glaucomatous SAP progression and may be used as a predictor of risk of glaucomatous progression.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
{"title":"Relationship between Blood Pressure and Rates of Glaucomatous Visual Field Progression","authors":"Richard Donkor MSc, PhD, Alessandro A. Jammal MD, PhD, David S. Greenfield MD","doi":"10.1016/j.ophtha.2024.07.026","DOIUrl":"10.1016/j.ophtha.2024.07.026","url":null,"abstract":"<div><h3>Purpose</h3><div>To examine the relationship between systemic arterial blood pressure (BP) and the rate of change in standard automated perimetry (SAP) in eyes with glaucoma and suspected glaucoma.</div></div><div><h3>Design</h3><div>Prospective cohort study.</div></div><div><h3>Participants</h3><div>One hundred twenty-four eyes (91 eyes with glaucoma, 33 eyes with suspected glaucoma) of 64 patients (mean age, 68.4 ± 7.6 years) followed up at the Bascom Palmer Eye Institute, Palm Beach Gardens, Florida.</div></div><div><h3>Methods</h3><div>Participants underwent ophthalmic examination, BP measurement, and SAP at 4-month intervals. At the baseline visit, 24-hour ambulatory blood pressure monitoring (ABPM) was acquired. Linear mixed models (adjusted for inclusion of both eyes, age, sex, race, intraocular pressure, baseline severity, and central corneal thickness) were used to investigate the effect of BP on the rates of SAP mean deviation (MD) change over time.</div></div><div><h3>Main Outcome Measures</h3><div>Effect of baseline 24-hour and follow-up mean arterial pressure (MAP), systolic BP (SBP), and diastolic BP on change in SAP MD.</div></div><div><h3>Results</h3><div>Eyes underwent an average of 8.9 ± 1.5 SAP examinations over 28.3 ± 6.0 months of follow-up. The median rate of MD change was 0.14 dB/year (range, –1.21 to 0.96 dB/year) with 9 eyes (7%) showing moderate to fast progression (MD change, ≤ –0.50 dB/year). Each 10 mmHg lower in 24-hour average MAP and SBP were associated with –0.171 dB/year (<em>P</em> = 0.045) and –0.137 dB/year (<em>P</em> = 0.023) faster rates of MD loss. Lower mean SBP during follow-up was associated significantly (<em>P</em> = 0.003) with MD progression.</div></div><div><h3>Conclusions</h3><div>Lower baseline 24-hour ABPM measurements, as well as low SBP during follow-up, were associated significantly with faster rates of glaucomatous SAP progression and may be used as a predictor of risk of glaucomatous progression.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":19533,"journal":{"name":"Ophthalmology","volume":"132 1","pages":"Pages 30-38"},"PeriodicalIF":13.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141902523","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01DOI: 10.1016/j.ophtha.2024.07.021
Abdelhalim A. Awidi MD , Fasika A. Woreta MD, MPH , Ahmed Sabit MS , Haihong Hu MS , Niteesh Potu MS , Eva Devience MD , Jiangxia Wang MA, MS , Suma Vupputuri PhD, MPH
Purpose
To compare the associations of race, ethnicity, and socioeconomic status (SES) with visual impairment (VI) before surgical removal of cataracts across 2 health systems in the United States Mid-Atlantic region.
Design
Multi-institutional cross-sectional study.
Participants
Patients ≥ 65 years of age who underwent cataract surgery at Johns Hopkins Hospital (JHH) and Kaiser Permanente (KP) between January 1, 2017, and December 31, 2019.
Methods
Covariates included patient age, sex, smoking status, surgery laterality, Charlson comorbidity index, and ocular comorbidities. Multivariable generalized estimating equation models were used to examine the association of race, ethnicity, and area deprivation index (ADI) with visual acuity.
Main Outcome Measures
Visual acuity before cataract surgery was assessed using logarithm of minimum angle of resolution values. Race, ethnicity, and ADI were the main exposures of interest.
Results
At JHH, 11 509 patients (17 731 eyes) were included, whereas KP included 7143 patients (10 542 eyes). After adjusting for covariates, Black patients (β = 0.49), Asian patients (β = 0.83), and Hispanic patients (β = 0.95) were more likely to have worse visual acuity at JHH (P < 0.001 for all) compared with White patients. Similarly, at KP, Black patients (β = 0.56), Asian patients (β = 0.70), and Hispanic patients (β = 0.89) were more likely to have worse visual acuity (P < 0.001 for all) compared with White patients. Compared with those living in the least disadvantaged neighborhoods at JHH, higher ADI quartiles (more deprived) were more likely to have worse visual acuity (β = 0.27 [P < 0.001] for quartile 2; β = 0.40 [P = 0.001] for quartile 3; β = 0.95 [P < 0.001] for quartile 4). No significant association was found between ADI and VI at KP.
Conclusions
Among older adults, non-White race or ethnicity was associated independently with VI secondary to cataracts in 2 large health systems in the United States Mid-Atlantic region, after adjustment for ADI. Area deprivation also was associated with VI but only in the JHH system. Our study suggests that non-White patients and those with lower SES are at greater risk of VI secondary to cataracts possibly because of social, structural, and institutional barriers.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
目的:比较美国大西洋中部地区两个大型医疗系统中种族/民族和社会经济地位(SES)与白内障手术切除前视力损伤(VI)的关系:设计:多机构横断面数据研究:2017年1月1日至2019年12月31日期间在约翰霍普金斯医院(JHH)和凯撒医疗集团(KP)接受白内障手术的65岁及以上患者:协变量包括患者年龄、性别、吸烟状况、手术侧位、Charlson合并症指数(CCI)和眼部合并症。采用多变量广义估计方程模型研究种族/民族和地区贫困指数(ADI)与视力的关系:白内障手术前的视力使用最小分辨角度对数(logMAR)进行评估。种族/民族和 ADI 是主要的研究对象:JHH共纳入11509名患者(17731只眼),而KP共纳入7143名患者(10542只眼)。调整协变量后,与白人患者相比,黑人患者(β,0.49)、亚裔患者(β,0.83)和西班牙裔患者(β,0.95)在 JHH 更有可能因白内障而导致视力下降(P < 0.001)。同样,与白人患者相比,黑人患者(β,0.56)、亚裔患者(β,0.70)和西班牙裔患者(β,0.89)的视力更差(P < 0.001)。与居住在 JHH 最贫困社区(ADI 四分位数 [Q] 1)的患者相比,ADI 四分位数越高(越贫困)的患者视力越差(β,0.27;Q2,P = 0.001;β,0.40;Q3,P = 0.001;β,0.95;Q4,P < 0.001)。在 KP 发现,ADI 与继发于白内障的 VI 之间没有明显关联:结论:在美国大西洋中部地区的两个大型医疗系统中,在调整 ADI 后,老年人中的非白人种族/族裔与继发性白内障 VI 有独立关联。地区贫困也与白内障相关,但仅限于 JHH 系统。我们的研究表明,非白人患者和社会经济地位较低的患者因白内障而继发视力丧失的风险更大,这可能是由于社会、结构和体制障碍造成的。
{"title":"The Effect of Racial, Ethnic, and Socioeconomic Differences on Visual Impairment before Cataract Surgery","authors":"Abdelhalim A. Awidi MD , Fasika A. Woreta MD, MPH , Ahmed Sabit MS , Haihong Hu MS , Niteesh Potu MS , Eva Devience MD , Jiangxia Wang MA, MS , Suma Vupputuri PhD, MPH","doi":"10.1016/j.ophtha.2024.07.021","DOIUrl":"10.1016/j.ophtha.2024.07.021","url":null,"abstract":"<div><h3>Purpose</h3><div>To compare the associations of race, ethnicity, and socioeconomic status (SES) with visual impairment (VI) before surgical removal of cataracts across 2 health systems in the United States Mid-Atlantic region.</div></div><div><h3>Design</h3><div>Multi-institutional cross-sectional study.</div></div><div><h3>Participants</h3><div>Patients ≥ 65 years of age who underwent cataract surgery at Johns Hopkins Hospital (JHH) and Kaiser Permanente (KP) between January 1, 2017, and December 31, 2019.</div></div><div><h3>Methods</h3><div>Covariates included patient age, sex, smoking status, surgery laterality, Charlson comorbidity index, and ocular comorbidities. Multivariable generalized estimating equation models were used to examine the association of race, ethnicity, and area deprivation index (ADI) with visual acuity.</div></div><div><h3>Main Outcome Measures</h3><div>Visual acuity before cataract surgery was assessed using logarithm of minimum angle of resolution values. Race, ethnicity, and ADI were the main exposures of interest.</div></div><div><h3>Results</h3><div>At JHH, 11 509 patients (17 731 eyes) were included, whereas KP included 7143 patients (10 542 eyes). After adjusting for covariates, Black patients (β = 0.49), Asian patients (β = 0.83), and Hispanic patients (β = 0.95) were more likely to have worse visual acuity at JHH (<em>P</em> < 0.001 for all) compared with White patients. Similarly, at KP, Black patients (β = 0.56), Asian patients (β = 0.70), and Hispanic patients (β = 0.89) were more likely to have worse visual acuity (<em>P</em> < 0.001 for all) compared with White patients. Compared with those living in the least disadvantaged neighborhoods at JHH, higher ADI quartiles (more deprived) were more likely to have worse visual acuity (β = 0.27 [<em>P</em> < 0.001] for quartile 2; β = 0.40 [<em>P</em> = 0.001] for quartile 3; β = 0.95 [<em>P</em> < 0.001] for quartile 4). No significant association was found between ADI and VI at KP.</div></div><div><h3>Conclusions</h3><div>Among older adults, non-White race or ethnicity was associated independently with VI secondary to cataracts in 2 large health systems in the United States Mid-Atlantic region, after adjustment for ADI. Area deprivation also was associated with VI but only in the JHH system. Our study suggests that non-White patients and those with lower SES are at greater risk of VI secondary to cataracts possibly because of social, structural, and institutional barriers.</div></div><div><h3>Financial Disclosure(s)</h3><div>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</div></div>","PeriodicalId":19533,"journal":{"name":"Ophthalmology","volume":"132 1","pages":"Pages 98-107"},"PeriodicalIF":13.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141734750","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-01-01DOI: 10.1016/j.ophtha.2024.09.018
Yating Zhou MD, Fei Xue MD
{"title":"Re: Potter et al.: Concordance between self-reported visual difficulty and objective visual impairment: The National Health and Aging Trends Study (Ophthalmology. 2024;131:1447-1456)","authors":"Yating Zhou MD, Fei Xue MD","doi":"10.1016/j.ophtha.2024.09.018","DOIUrl":"10.1016/j.ophtha.2024.09.018","url":null,"abstract":"","PeriodicalId":19533,"journal":{"name":"Ophthalmology","volume":"132 1","pages":"Pages e4-e5"},"PeriodicalIF":13.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142505262","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}