Ophthalmology最新文献

Purpose: Complications associated with intravitreal anti-VEGF therapies are reported inconsistently in the literature, thus limiting an accurate evaluation and comparison of safety between studies. This study aimed to develop a standardized classification system for anti-VEGF ocular complications using the Delphi consensus process.

Design: Systematic review and Delphi consensus process.

Participants: Twenty-five international retinal specialists participated in the Delphi consensus survey.

Methods: A systematic literature search was conducted to identify complications of intravitreal anti-VEGF agent administration based on randomized controlled trials (RCTs) of anti-VEGF therapy. A comprehensive list of complications was derived from these studies, and this list was subjected to iterative Delphi consensus surveys involving international retinal specialists who voted on inclusion, exclusion, rephrasing, and addition of complications. Furthermore, surveys determined specifiers for the selected complications. This iterative process helped to refine the final classification system.

Main outcome measures: The proportion of retinal specialists who choose to include or exclude complications associated with anti-VEGF administration.

Results: After screening 18 229 articles, 130 complications were categorized from 145 included RCTs. Participant consensus via the Delphi method resulted in the inclusion of 91 complications (70%) after 3 rounds. After incorporating further modifications made based on participant suggestions, such as rewording certain phrases and combining similar terms, 24 redundant complications were removed, leaving a total of 67 complications (52%) in the final list. A total of 14 complications (11%) met exclusion thresholds and were eliminated by participants across both rounds. All other remaining complications not meeting inclusion or exclusion thresholds also were excluded from the final classification system after the Delphi process terminated. In addition, 47 of 75 proposed complication specifiers (63%) were included based on participant agreement.

Conclusions: Using the Delphi consensus process, a comprehensive, standardized classification system consisting of 67 ocular complications and 47 unique specifiers was established for intravitreal anti-VEGF agents in clinical trials. The adoption of this system in future trials could improve consistency and quality of adverse event reporting, potentially facilitating more accurate risk-benefit analyses.

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

Purpose: The Laser in Glaucoma and Ocular Hypertension Trial demonstrated the efficacy and safety of selective laser trabeculoplasty (SLT) compared with topical hypotensive medication as first-line therapy for ocular hypertension and open-angle glaucoma. This substudy explored the impact of pretreatment (baseline) intraocular pressure (IOP) on treatment response.

Design: Post hoc analysis of randomized control trial data.

Participants: A total of 1146 eyes from 662 patients were included in this analysis: 559 eyes in the SLT group and 587 in the medication group.

Methods: Intraocular pressure reduction at 8 weeks after treatment with either SLT or prostaglandin analog (PGA) eye drops was assessed at different levels of baseline IOP, and the groups were compared. Differences in absolute and percentage IOP lowering between SLT and PGA groups were tested with a linear mixed-effects model. Differences in the probability of achieving ≥ 20% IOP lowering between SLT and PGA groups, at different levels of baseline IOP, were estimated using a logistic mixed-effects model.

Main outcome measure: Intraocular pressure-lowering response to SLT versus PGA eye drops.

Results: Mean IOP was not significantly different between the groups at baseline or 8 weeks after treatment initiation. Both treatments showed greater IOP lowering at higher baseline IOP and less IOP lowering at lower baseline IOP. Selective laser trabeculoplasty tended to achieve more IOP lowering than PGA drops at higher baseline IOP. Prostaglandin analog drops performed better at lower baseline IOP, and the difference compared with SLT, in terms of percentage IOP reduction, was significant at baseline IOP of ≤ 17 mmHg. A significant difference was found in the relationship between baseline IOP and probability of ≥ 20% IOP lowering between the two treatments (P = 0.01), with SLT being more successful than PGA at baseline IOP of more than 22.5 mmHg.

Conclusions: We confirm previous reports of greater IOP lowering with higher baseline IOP for both SLT and PGA drops. In treatment-naïve eyes, at higher baseline IOP, SLT was more successful at achieving ≥ 20% IOP lowering than PGA drops. At lower baseline IOP, a statistically greater percentage, but not absolute, IOP lowering was seen with PGA drops compared with SLT, although the clinical significance of this is uncertain.

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

Purpose: To examine the performance of self-reported visual difficulty (VD) in predicting objective visual impairment (VI) in older adults and explore factors that influence discordance.

Design: Cross-sectional analysis of the National Health and Aging Trends Study (2022).

Methods: Participants reporting blindness or difficulties with distance or near vision were characterized as having VD. Presenting binocular distance visual acuity (VA), near VA, and contrast sensitivity (CS) were assessed. Objective VI was defined as having VI in distance VA (worse than 20/40), near VA (worse than 20/40), or CS (worse than 1.55 logCS). Receiver operating characteristic analysis was used to compare performance of VD in predicting VI. To investigate factors that influence discordance, we limited our sample to adults with VI and used a multivariable logistic regression model to identify factors associated with not reporting VD. Similar analyses were performed to explore factors associated with reporting VD in adults without VI.

Main outcome measures: Discordance factors.

Results: Four thousand nine hundred ninety-nine adults were included in the 2022 cohort. Visual difficulty achieved an area under the curve (AUC) of 56.0 (95% confidence interval [CI], 55.2-56.9) in predicting VI, with a sensitivity of 15.8 (95% CI, 14.2-17.5) and specificity of 96.3 (95% CI, 95.5-96.9). Characteristics associated with not reporting VD in adults with VI included female gender (odds ratio [OR], 0.64 [95% CI, 0.42-0.99]), Hispanic ethnicity (OR, 0.49 [95% CI, 0.31-0.78), higher income (≥75 000, OR, 1.99 [95% CI, 1.14-3.45]), ≥4 comorbidities (OR, 0.46 [95% CI, 0.29-0.72]), and depressive symptoms (OR, 0.49 [95% CI, 0.25-0.93]). Factors associated with self-reporting VD in the absence of VI included Hispanic ethnicity (OR, 2.11 [95% CI, 1.15-3.86]), higher income (≥$75 000, OR, 0.27 [95% CI, 0.12-0.63]), and anxiety symptoms (OR, 3.05 [95% CI, 1.56-5.97]).

Conclusions: Self-reported VD is a distinct measure assessing disability and has limited ability in predicting objective VI. Caution is advised when using self-reported VD as a surrogate measure for objective VI in epidemiological studies, although it may still be an effective way to capture risk of current or future disability.

Financial disclosure(s): Proprietary or commercial disclosure may be found after the references.

Purpose: To investigate the incidence and outcomes of retinal tear (RT) and retinal detachment (RD) after cataract extraction in patients with a history of previous phakic RT.

Design: Retrospective case series.

Participants: Patients with phakic eyes with RT that were treated successfully with laser photocoagulation or cryotherapy and subsequently underwent cataract surgery.

Methods: A retrospective review of data between April 1, 2012, and May 31, 2023, was performed. Exclusions included prior vitreoretinal surgery before cataract removal and follow-up of less than 6 months after cataract surgery.

Main outcome measures: The incidence of RTs and RDs after cataract surgery, along with visual and anatomic outcomes.

Results: Of 12 109 phakic eyes treated for RTs, 1039 eyes (8.6%) underwent cataract surgery. After exclusions, 713 eyes of 660 patients were studied. The mean ± standard deviation follow-up period after cataract surgery was 34.8 ± 24.6 months, with a median of 239 and 246 days to a new RT or RD development, respectively. The overall incidence of RT and RD diagnosis after cataract surgery was 7.3% (52/713; 2.9% and 4.3%, respectively), with a 1-year incidence of 5.6% (2.2% and 3.4%, respectively). Multivariable regression analysis identified a higher risk of RT and RD among younger individuals (odds ratio [OR], 1.034; P = 0.028), male patients (OR, 2.058; P = 0.022), and those with a shorter interval between laser treatment and cataract surgery (OR, 1.001; P = 0.011). Single-surgery anatomic success for the RD repair was achieved in 25 eyes (80.6%) at 3 months, with a 100% final reattachment rate. The median final visual acuity was 0.10 logarithm of the minimum angle of resolution (logMAR; Snellen equivalent, 20/25) for RT, showing no significant change from after cataract surgery, and 0.18 logMAR (Snellen equivalent, 20/30) for RD, a significant worsening from after cataract surgery.

Conclusions: One year after cataract surgery, the rate of diagnosed RT and RD in patients with previously treated RTs was relatively high, occurring in nearly 1 in 18 eyes. Higher risk was noted among younger individuals, male patients, and patients with a shorter interval between initial treatment for RT and cataract surgery. Retinal detachment repair achieved good anatomic results, but vision declined.

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

Purpose: To validate the ability of theranostic imaging biomarkers in assessing corneal cross-linking (CXL) efficacy in flattening the maximum keratometry (K_max) index.

Design: Prospective, randomized, multicenter, masked clinical trial (ClinicalTrails.gov identifier, NCT05457647).

Participants: Fifty patients with progressive keratoconus.

Intervention: Participants were stratified to undergo epithelium-off (25 eyes) and epithelium-on (25 eyes) CXL protocols using an ultraviolet A (UV-A) medical device with theranostic software. The device controlled UV-A light both for performing CXL and assessing the corneal riboflavin concentration (riboflavin score) and treatment effect (theranostic score). A 0.22% riboflavin formulation was applied onto the cornea for 15 minutes and 20 minutes in epithelium-off and epithelium-on protocols, respectively. All eyes underwent 9 minutes of UV-A irradiance at 10 mW/cm².

Main outcome measures: The primary outcome measure was validation of the combined use of theranostic imaging biomarkers through measurement of their accuracy (proportion of correctly classified eyes) and precision (positive predictive value) to classify eyes correctly and predict a K_max flattening at 1 year after CXL. Other outcome measures included change in K_max, endothelial cell density, uncorrected and corrected distance visual acuity, manifest spherical equivalent refraction and central corneal thickness 1 year after CXL.

Results: Accuracy and precision of the theranostic imaging biomarkers in predicting eyes that had >0.1 diopter (D) of K_max flattening at 1 year were 91% and 95%, respectively. The K_max value significantly flattened by a median of -1.3 D (IQR, -2.11 to -0.49 D; P < 0.001); both the uncorrected and corrected distance visual acuity improved by a median of -0.1 logarithm of the minimum angle of resolution (logMAR; IQR, -0.3 to 0.0 logMAR [P < 0.001] and -0.2 to 0.0 logMAR [P < 0.001], respectively). No significant changes in endothelial cell density (P = 0.33) or central corneal thickness (P = 0.07) were noted 1 year after surgery.

Conclusions: The study demonstrated the efficacy of integrating theranostics in a UV-A medical device for the precise and predictive treatment of keratoconus with epithelium-off and epithelium-on CXL protocols. Concentration of riboflavin and its UV-A light mediated photoactivation in the cornea are the primary factors determining CXL efficacy.

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 safety and tolerability of a single intravitreal injection of JNJ-81201887 (JNJ-1887) in patients with geographic atrophy (GA) secondary to advanced dry age-related macular degeneration (AMD).

Design: Phase 1, open-label, single-center, first-in-human clinical study.

Participants: Adult patients (≥50 years of age) with GA secondary to AMD in the study-treated eye (treated eye) with Snellen best-corrected visual acuity of 20/200 or worse in the treated eye (20/80 or worse after the first 3 patients), a total GA lesion size between 5 and 20 mm² (2-8 disc area), and best-corrected visual acuity of 20/800 or better in fellow, nontreated eye were included.

Methods: Patients (n = 17) were enrolled sequentially into low-dose (3.56 × 10¹⁰ viral genome/eye; n = 3), intermediate-dose (1.07 × 10¹¹ viral genome/eye; n = 3), and high-dose (3.56 × 10¹¹ viral genome/eye; n = 11) cohorts without steroid prophylaxis and assessed for safety and tolerability over 24 months.

Main outcome measures: Safety and tolerability outcomes included assessment of ocular and nonocular treatment-emergent adverse events (AEs) over 24 months. Secondary outcomes included GA lesion size and growth rate.

Results: Baseline patient characteristics were consistent with the disease under study, and all enrolled patients demonstrated foveal center-involved GA. JNJ-81201887 was well-tolerated across all cohorts, with no dose-limiting AEs. No serious or systemic AEs related to study intervention occurred. Overall, 5 of 17 patients (29%) experienced 5 events of mild ocular inflammation related to study treatment; examination findings in all resolved, and AEs resolved in 4 of 5 patients after topical steroids or observation. One unresolved vitritis event, managed with observation, occurred in a patient with an unrelated fatal AE. No endophthalmitis or new-onset choroidal neovascularization was reported. Geographic atrophy lesion growth rate was similar among all cohorts over 24 months. For treated eyes in the high-dose cohort, GA lesion growth rate showed continued decline through 24 months, with a reduction in mean square root lesion growth from 0.211 mm at months 0 through 6 to 0.056 mm at months 18 through 24.

Conclusions: All 3 studied doses of JNJ-1887 showed a manageable safety profile through 24 months of follow-up. Further investigation of JNJ-1887 for the treatment of GA is warranted.

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