Ophthalmology. Glaucoma最新文献

Purpose: To evaluate long-term systemic risks associated with neovascular glaucoma (NVG) using a large, real-world dataset from the TriNetX Research Network.

Design: Retrospective Cohort Study SUBJECTS: Adults > 40 years old with central retinal vein occlusion (CRVO) or proliferative diabetic retinopathy (PDR) were compared based on whether they did or did not subsequently develop NVG.

Methods: Patients were propensity score matched 1:1 based on demographics and comorbidities. Outcomes were assessed at 1, 5, and 10 years using hazard ratios (HRs) with 95% confidence intervals (CIs). Subgroup analysis compared outcomes in NVG+PDR versus CRVO+NVG. NVG patients were also compared to a cataract control cohort.

Main outcome measures: Risk of all-cause mortality, stroke, myocardial infarction (MI), end-stage renal disease (ESRD), and deep-vein thrombosis (DVT).

Results: Patients with PDR who developed NVG had a higher long-term risk than PDR alone, including elevated 10-year mortality (HR 1.34, 95% CI 1.14-1.57) and ESRD (HR 1.43, 95% CI 1.23-1.67). Among patients with CRVO, development of NVG increased 10-year mortality (HR 1.61, 95% CI 1.17-2.20) and stroke (HR 1.86, 95% CI 1.19-2.90), while MI and ESRD were not significantly different. DVT risk was not significantly different. Subgroup comparison showed that PDR-NVG had higher 10-year risk of mortality (HR 1.56, 95% CI 1.17-2.07), MI (HR 1.94, 95% CI 1.13-3.32), and ESRD (HR 4.04, 95% CI 2.43-6.73) compared with CRVO-NVG. Compared with cataract control at 10 years, NVG was associated with higher risks of mortality (HR 2.66, 95% CI 2.40-2.94), stroke (HR 2.17, 95% CI 1.85-2.54), MI (HR 1.89, 95% CI 1.60-2.23), and ESRD (HR 3.34, 95% CI 2.89-3.88).

Conclusions: NVG itself appears to add systemic risk beyond underlying PDR or CRVO, suggesting that the onset of NVG may represent a critical breakpoint in the spectrum of systemic vascular disease. Our results highlight the importance of coordinated ophthalmic and multispecialty care at the time of diagnosis.

Topic: Glaucoma surgical practice has changed over the past 2 decades. We investigated how the earliest stages of glaucoma surgical innovations have been conducted and reported.

Clinical relevance: Surgical innovations are crucial to improve patient care. However, developing novel techniques and devices presents unique challenges that make rigorous evaluation and reporting difficult. To support surgeons and researchers, the Idea, Development, Exploration, Assessment, Long-term follow-up (IDEAL) collaboration has issued guidelines aimed at facilitating improvements in the conduct and reporting of surgical innovations at different stages.

Methods: We have considered all glaucoma surgical innovations introduced in the past 2 decades and searched for the initial reports of each technique, targeting "first-in-human" and first case series. We have searched for human studies in PubMed Central, Scopus, Google Scholar, Clinicaltrials.gov., and grey literature was also included. We used the IDEAL collaboration stages 1 ("idea") and 2a ("development") checklists to assess the quality of reporting. Checklists include items on study design, consenting, protocol availability, ethical and regulatory approvals. The study protocol was prospectively registered at Open Science Framework.

Results: We identified 21 different techniques and devices. Among the 53 included studies, 22 were earliest reports (IDEAL stage 1) and 31 were categorized as development assessment (IDEAL stage 2a). The techniques most represented were trabecular dilatation or disrupting surgeries (25 studies), trabecular stenting (10 studies) and suprachoroidal devices (10 studies). In the IDEAL stage 1, 81.8% of studies identified the device or technique in the title or abstract or referred to the "first-in-human" experience, and 77.3% provided structured summaries, with detailed outcome measures. Technical feasibility was addressed in 63.6% of studies, however only 9% explicitly described an informed consent process, and 59% lacked references to ethical approvals. In the IDEAL stage 2a, 77% of studies included structured summaries, and 70% discussed the need for evaluation in a prospective multicenter study. Clinical outcomes, adverse events and modifications to techniques were reported in equal proportion (61.3%); furthermore, 70% discussed the feasibility of further evaluation. Nevertheless, only 13% detailed the informed consent process, and 80% omitted details of regulatory approvals. A pre-study protocol was available in only 1 study.

Conclusion: Critical aspects of study design and reporting were frequently missing in early-phase surgical studies of glaucoma. The IDEAL framework offers a structured approach to bridge these gaps and improve the quality of glaucoma surgical innovation reporting.

Purpose: To identify clinical and demographic predictors of intraocular pressure (IOP)-lowering success following goniotomy in a large, real-world cohort using the American Academy of Ophthalmology IRIS® Registry (Intelligent Research in Sight).

Design: Retrospective clinical cohort study.

Participants: Adults who underwent goniotomy between 2013 and 2022 in the IRIS Registry (n = 48,098).

Methods: Multivariable logistic regression and Cox proportional hazards models were used to evaluate predictors of short-term surgical success (defined as ≥20% IOP reduction without medication data) and long-term failure. Kaplan-Meier analysis assessed cumulative success rates. Mean IOP over 36 months were compared across glaucoma subtypes and disease severity.

Main outcome measures: Predictors of short-term success and long-term failure; changes in mean IOP over 36 months.

Results: Among 48,098 eyes, 52% achieved short-term success by 6 months. Mean IOP decreased from baseline 16.8mmHg to 15.06mmHg (10.4% decrease) after phaco-goniotomy (n=31,861) and from 21.28mmHg to 15.26mmHg (28.3% decrease) after standalone goniotomy (n=3,776) 36 months post-operatively. Higher baseline IOP, older age, male sex, severe glaucoma, concurrent cataract surgery, pseudoexfoliation glaucoma (PXG), and low-tension glaucoma (LTG) were independently associated with higher odds of short-term success and lower risk of long-term failure (all P < 0.05). Postoperative pilocarpine use (assumed to be applicable to the surgical eye) conferred greater odds of short-term success and greater odds of long-term failure.

Conclusions: In this large national cohort, several demographic and clinical factors-including higher baseline IOP, more severe glaucoma, PXG and LTG diagnoses-were predictive of goniotomy success. These findings suggest that goniotomy may benefit patient groups not traditionally prioritized for minimally invasive glaucoma surgery.

Purpose: To compare the 12-month effectiveness and safety of 63-μm gelatin microstent (Xen63) with 45-μm gelatin microstent (Xen45) implantation.

Design: Multicenter, retrospective cohort study.

Subjects: Two hundred eyes of 200 patients (100 in each 63-μm and 45-μm gelatin microstent group), with or without phacoemulsification.

Methods: Consecutive patients undergoing 63-μm microstent implantation at 6 centers across 4 countries (Canada, Italy, Austria, Belgium), were compared to matched controls who underwent 45-μm microstent implantation.

Outcome measures: Primary outcome measure was the probability of complete surgical success at 1 year, defined as 1) no two consecutive IOP >14 mmHg or < 6 mmHg with two lines of vision loss; and (2) ≥20% reduction from decision IOP, without glaucoma medications or reoperations. Qualified success allowed glaucoma medications and laser trabeculoplasty. Secondary outcomes included surgical success with upper IOP cut-offs of 17mmHg and 21mmHg, postoperative IOP and medications course, complications, interventions and reoperations.

Results: Complete success favored 63-μm microstent (56.9% vs 43.9%, P=0.017), using IOP cut-off of 14mmHg. 45-μm microstent was associated with increased hazard of surgical failure compared to 63-μm microstent (HR 1.9; 95% CI 1.2-3.0). Complete success using IOP cut-offs of 17 and 21mmHg, in the 63 vs 45-μm group was 60.1% vs 53.9% (P=0.156), and 60.1% vs 55.0% (P=0.243). Qualified success wasn't significantly different between the two groups using any IOP threshold (P>0.05). At 12 months, 63-μm group had significantly lower IOP (mean 14.6±7.6 vs 15.8±6.1 mmHg, P=0.021) and medication count (0.6±1.1 vs 1.1±1.5, P=0.024) compared to 45-μm group. Postoperative needling was performed in 16.0% and 18.0% of 63-μm and 45-μm microstent implanted eyes, respectively. Incidence of early postoperative choroidal effusion was higher in 63-μm group (25.0% vs 6.0%, P<0.001). Interventions (62.0% vs 59.0%) and reoperations (21.0% vs 15.0%) were comparable between the two groups (P>0.050).

Conclusions: The 63-μm gelatin microstent demonstrated superior IOP lowering effectiveness compared to its 45-μm variant in patients requiring more robust IOP targets. The 63-μm gelatin microstent implanted eyes required less medications to achieve their target, but experienced a higher incidence of early postoperative hypotony-related complications such as choroidal detachment, majority of which were transient.

Purpose: Acute angle closure (AAC) is a sight-threatening ophthalmic emergency. However, it remains uncertain whether the incidence of AAC-related blindness has declined in recent years. This study aimed to provide a contemporary analysis of the rate, clinical characteristics, and management outcomes of AAC-related blindness in China.

Design: Multicentric, retrospective observational study.

Subjects: Data of consecutive AAC cases were collected from 23 hospitals throughout China during three distinct periods: September 7, 2020, to January 6, 2021; September 7, 2021, to January 6, 2022; and September 7, 2022, to January 6, 2023.

Methods: Clinical data were retrospectively gathered through a standardized chart review. Generalized Estimating Equations was employed to compare biometric parameters, corrected distance visual acuity (CDVA), uncorrected distance visual acuity (UDVA), and blindness rates before and after treatment.

Main outcome measures: The primary outcome was the rate of blindness, determined by CDVA and UDVA, both before and after treatment. Secondary outcomes included the time from symptom onset to treatment and its effect on blindness rates, along with the effectiveness of laser and surgical interventions in reducing these rates.

Results: Among the 2626 consecutive AAC patients included in the study (76.0% female; mean age 66.8±9.2 years), only 34.3% sought treatment within 72 hours of symptom onset. At presentation, blindness rates were 28.6% for CDVA and 42.4% for UDVA. After intervention, these rates significantly decreased to 16.4% for CDVA (p<0.001) and 20.1% for UDVA (p<0.001). Both laser and surgical treatments significantly improved mean LogMAR visual acuity with CDVA improving from 0.42 to 0.29 for laser treatment and from 0.88 to 0.65 for surgery.

Conclusions: Active treatment significantly reduced the AAC-related blindness rate from 28.6% at presentation to 16.4% after intervention. However, the persistently high rate of blindness was strongly associated with delayed medical presentation, underscoring an urgent need for initiatives that improve early access to care.

Purpose: to compare the statistical power of structural and visual field (VF) outcomes for randomised clinical trials (RCTs) in glaucoma.

Design: analysis of retrospectively collected data.

Participants: Eighty-two glaucoma patients were recruited to a test-retest study, during which up to ten 24-2 SITA Standard VF and circumpapillary retinal nerve fibre layer (cpRNFL) Spectralis OCT scans were collected in separate sessions over 3 months.

Methods: Eyes with at least three sessions with a reliable VF (false positives < 15%) and cpRNFL scan (quality index ≥ 25 dB) were selected (127 eyes, 68 patients) to model the test-retest variability and the structural floor effect. These estimates were combined with a published realistic structure-function progression model from the United Kingdom Glaucoma Treatment Study to simulate longitudinal RCTs (30% neuroprotective effect). Simulations only included data from eyes with early to moderate VF loss (Mean Deviation, MD, ≥-10 dB, 107 eyes, 65 patients). Simulations were repeated 5000 times to estimate sample size requirements to detect a significant difference (p < 0.05) in the rate of change of MD and average cpRNFL thickness, estimated with a linear mixed effect model. We also tested the power of a significant outcome with either metric (p < 0.025). A supplementary analysis was performed including eyes with early VF loss only (MD ≥-6 dB).

Main outcome measures: sample size at 80% power for the linear rate of MD, cpRNFL and their combination.

Results: at 80% power, the required sample size (patients [95%-Confidence Interval]) was 38% smaller for the MD rate (292 [300, 283]) than the cpRNFL rate (470 [481, 459]). The sample size for the combined outcome was only marginally smaller than the MD alone (275 [283, 268]). The supplementary analysis on eyes with early VF loss showed similar results.

Conclusions: Using realistic modelling of structure-function progression and test-retest data, MD progression showed higher statistical power cpRFNL as an outcome measure for clinical trials.

Purpose: To evaluate the predictive ability of baseline wide-field optical coherence tomography (OCT)-based risk scores for the development of perimetric glaucoma in glaucoma suspect eyes.

Design: Prospective cohort study.

Participants: 257 glaucoma suspect eyes with normal visual fields (VF) at baseline from 180 patients.

Methods: Baseline macular and peripapillary inner retinal layer thickness measurements were obtained using swept-source OCT wide-field scans (12mmx9mm) that included both the optic disc and macula. Three OCT-based risk scores were calculated for each eye using measurement segments and grids from the OCT reports. Glaucoma progression was defined as the development of repeatable abnormal VF results. Marginal Cox proportional hazards model was applied to evaluate baseline predictors, including risk scores and individual OCT thickness metrics, with adjustment for confounding factors.

Main outcome measure: Time-dependent receiver operating characteristic (ROC) curves and decision curve analysis (DCA) evaluated model performance and clinical utility.

Results: The mean follow-up time for glaucoma suspects was 2.8 years. During this period, 80 suspect eyes progressed to perimetric glaucoma. Circumpapillary retinal nerve fiber layer (cpRNFL) thickness, ganglion cell complex (GCC) thickness, ganglion cell-inner plexiform layer (GCIPL) thickness, mean deviation (MD), and the 3 OCT-based risk scores were predictors of progression in univariable models, showing significant hazard ratios (HRs), whereas only the OCT-based risk scores remained statistically significant in multivariable models. Each 10-point increase in OCT-based risk scores across the 3 models corresponded to a 1.15 to 1.21-fold increase in risk. The risk scores demonstrated higher area under ROCs, compared to individual OCT parameters, across all time points. DCA showed that individual OCT parameters offered no greater net benefit than treating all patients regardless of risk, whereas the Fukai risk scores consistently yielded higher net benefit.

Conclusions: Baseline OCT-based risk scores from a single wide scan, incorporating both peripapillary RNFL and macular thickness measurements, are associated with the subsequent development of perimetric glaucoma development in glaucoma suspect eyes, offering valuable insights for risk stratification in a single integrated metric and may aid in early intervention and clinical management in glaucoma suspects.

Objective or purpose: To determine whether self-reported visual challenges in low lighting are associated with binocular severity of 24-2 visual field loss in people with glaucoma.

Design: Cross-sectional study PARTICIPANTS: Data from 128 participants with primary open-angle glaucoma (POAG) enrolled in the longitudinal cohort "Individualised Perimetry Progression Observations in Glaucoma Study" at Lions Eye Institute, Perth, Australia, were analysed.

Methods: Monocular visual fields were merged to form an integrated visual field (IVF) using the "best location method". Visual field locations were divided into four regions: central, peripheral, superior, and inferior. The Low Luminance Questionnaire (LLQ) and Glaucoma Quality of Life-15 (GQL-15) were self-administered electronically. The associations between questionnaire scores and visual field indices were assessed using linear regression, considering covariates of age, gender, lens status and best eye visual acuity. Correlations between the composite and subscales of LLQ and GQL-15 were calculated.

Main outcome measures: Association between self-reported difficulties under low luminance and binocularly integrated visual fields RESULTS: VF indices were associated with log-transformed composite LLQ scores. Piecewise linear regression identified breakpoints at 21.7dB (95%CI: 18.1 to 25.3 dB) and -6.3 dB (95%CI:-2.7 to -9.9dB), for global integrated VF mean sensitivity and TD, respectively. Inferior IVF defects were associated with difficulties at low light levels, especially with driving, adjusting for age, gender, lens status and better eye VA. The composite and subscales of the LLQ and GQL-15 were moderately correlated.

Conclusion: Self-reported difficulties at low light levels were partially explained by binocularly integrated visual field status in people with glaucoma. The LLQ identifies difficulties at low light levels, which are not captured by the standard clinical tests.

Standard methods of tonometry are limited by corneal factors. We present an innovative and readily available method of intracameral IOP measurement using an arterial line pressure transducer and discuss how it affected management of our patient and future applications.