Ophthalmology最新文献

Purpose: To evaluate long-term safety and performance of EYEMATE-SC sensor system, a suprachoroidal implantable diagnostic medical device designed for measuring intraocular pressure (IOP) in patients with glaucoma and offers direct digitized intraocular pressure (IOP) readings in mmHg.

Design: This study is part of the prospective, open-label, multicenter interventional EYEMATE-SC trial.

Subjects, participants and/or controls: Twenty-two eyes of 22 patients with open-angle glaucoma who received the implant in conjunction with non-penetrating glaucoma surgery (NPGS) were in included in the study.

Methods: This 3-years follow-up study analyzed long-term safety of the EYEMATE-SC suprachoroidal sensor system (Implandata, Hannover, Germany). The telemetric sensor system includes an implantable IOP sensor and a hand-held reading device.

Main outcome measures: All patients underwent 5 follow-up visits over a 24-month follow-up, from month 12 to month 36 after implantation. Each visit consisted of a comprehensive examination including IOP measurement with the EYEMATE-SC system and Goldmann applanation tonometry (GAT). The agreement between GAT and the EYEMATE-SC was analyzed using Bland-Altman analysis. Adverse events (AEs) and device-related adverse effects (ADEs) were recorded at all follow-up visits.

Results: Of 24 eligible patients of the EYEMATE-SC trial, 22 patients (mean age 65.0±10.6 years, 54.5% female) were enrolled. The overall mean follow-up was 2.7 ± 0.6 years (range 1.0 to 3.4 years). Limits of agreement between GAT and EYEMATE-SC IOP were -6.2 to 5.7 mmHg (mean absolute difference of 2.3 mmHg), with greatest concordance at 12 (concordance correlation coefficient (rccc) =0.802, N=22) and 18 months (rccc=0.854, N=19). A difference of less than 5 mmHg was recorded in more than 85% of the 86 paired measurements. No serious AEs and ADEs were recorded. Most common AEs were raised IOP in 5 patients, reduced visual acuity in 3 patients, and cataract in 3 patients.

Conclusions: This study demonstrates the long-term safety of the EYEMATE-SC system. No serious AEs related to the EYEMATE-SC were observed. The agreement between the EYEMATE-SC and GAT were within the standard range of IOP measuring methods set by regulatory agencies. The EYEMATE-SC system is well-tolerated and accurate for self- measurement of IOP throughout the day.

Objective: To determine how the rates of diabetic retinal disease (DRD) and its vision-threatening components (VTDR), diabetic macular edema (DME), and proliferative diabetic retinopathy (PDR) among patients with diabetes mellitus (DM) have changed over the past 20 years.

Design: Retrospective cohort study.

Subjects: All individuals in a US administrative medical claims database comprised of patients insured by commercial and Medicare Advantage insurance plans from 2000-2022 with DM and at least one full calendar year of data. Cohorts of patients with DM were created using ICD codes to determine the yearly prevalence and incidence of DRD, VTDR DME, and PDR.

Methods: Logistic and Poisson regression models were used to create prevalence and incidence estimates, respectively.

Main outcome measure: The main outcomes were the unadjusted prevalence and incidence of DRD, DME, and PDR.

Results: Among patients with DM, the prevalence of DRD initially decreased from 2001 (13.6%) to 2007 (10.9%) but then increased every year through 2021 (20.8%)(adjusted test for trend[aTT] p<0.001). DRD incidence varied considerably, ranging from 17.7 cases/1000 patient-years in 2013 to its highest of 32.2 in 2022 (aTT p<0.001). The prevalence of VTDR and DME trended similarly, with increases from 2007 (VTDR:5.2%; DME:3.2%) through 2016 (VTDR:7.5%; DME:5.4%) followed by decreases each year through 2021 (VTDR:6.9%; DME:4.9%)(aTT p<0.001). The VTDR and DME incidence rates also tracked similarly, with multi-year peaks in 2009 (VTDR:12.4; DME:8.6) and general decreases through 2022 (VTDR:6.1; DME:5.0)(aTT p<0.001 for both VTDR and DME). PDR prevalence varied between 3.2% and 4.0% throughout the 20-year observation, measuring 3.5% in 2021(aTT p<0.001). PDR incidence varied from 8.3 in 2002 to 7.0 in 2008, then decreased every year to 2.6 in 2022 (aTT p<0.001).

Conclusions and relevance: DRD Prevalence (through 2007) and incidence (through 2014) initially decreased, but the rate of each has since doubled. Despite increases in DRD, incidence rates of VTDR, DME, and PDR have dramatically improved over the past 20 years.

Purpose: Glucagon-like peptide-1 receptor agonists (GLP-1RAs) have risen exponentially in usage and have been shown to exert neuroprotective and anti-inflammatory effects across multiple organ systems. This study investigates whether GLP-1RAs influence the risk for age-related ocular diseases.

Design: Retrospective cohort study.

Subjects and participants: This study utilized an electronic health records platform of patients in the United States. Patients older than 60 years of age with at least five years of ophthalmology follow-up and medication prescription documentation were included. Patients were categorized into five medication groups: GLP-1RAs, metformin, insulin, statins, or aspirin users. Cohorts were propensity-matched on demographics and chronic health conditions using a greedy matching algorithm.

Main outcome measures: Outcomes of cataract, ocular hypertension, primary open angle glaucoma, non-exudative AMD, and exudative AMD were compared five years following initial medication prescription. We then examined earlier timepoints within the five-year period. Significance was defined as p<0.05 and HR threshold > 1.1 or < 0.9 to improve signal to noise ratio.

Results: Of the 9,669 patients taking GLP-1RAs, 84.4 percent were diabetic with an average BMI of 36.2. Propensity matched cohorts demonstrated GLP-1RAs were associated with reduced hazard of non-exudative AMD compared to metformin (HR 0.68, 95%CI: 0.56-0.84), insulin (HR 0.72, 95%CI: 0.58-0.89), and statins (HR 0.7, 95%CI: 0.57-0.87). These findings were validated compared to aspirin and in an independent older cohort of patients. This significant reduction appeared after three years compared to metformin (HR 0.69, 95%CI: 0.52-0.91), insulin (HR 0.66, 95%CI: 0.5-0.87), and statins (HR 0.67, 95%CI: 0.51-0.88). Time course results were validated using independent cohorts of propensity matched patients taking medications for three years. Notably, GLP-1RAs also significantly reduced the risk of exudative AMD (HR 0.7, 95%CI: 0.58-0.84) and POAG (HR 0.58, 95% CI 0.45-0.76) compared to insulin after three years. Usage of GLP-1RAs showed no persistent significant impact on the risk of cataract formation nor ocular hypertension after five years compared other medications.

Conclusions: This study suggests GLP-1RAs may reduce the risk of multiple age-related ocular diseases and suggests the need for future prospective studies to validate these findings.

Objective: Amblyopia is characterized by decreased visual acuity due to abnormal visual experience during development. It affects approximately three percent of the population and is associated with abnormal development of the visual cortex. Despite treatment, many patients have residual visual acuity deficits. This study aimed to explore the genetic contributions to amblyopia.

Design: Case-control.

Participants: The All of Us Research Program includes genotypic and phenotypic data from a diverse population of adults (age ≥ 18 years) across the United States. 764 subjects with amblyopia (based on ICD and SNOMED codes) and 122,305 controls with no record of amblyopia and whole genome sequencing were compared. Only participants of European genetic ancestry were included due to small numbers of affected participants in other ancestral groups.

Methods: Genome wide association study (GWAS) of common variants (minor allele frequency >1%) and rare variant association study (RVAS) at the gene level for amblyopia of participants in the All of Us Research Program.

Main outcome measures: Individual single-nucleotide polymorphisms (SNPs) significantly associated with amblyopia and genes with significant burden of rare variants in amblyopia RESULTS: The GWAS revealed 4 loci that approached statistical significance defined as p = 5e-8: rs56105618, rs1349660, rs7958343, and rs138693522. Each of the variants is an expression quantitative trait locus (eQTL) for a gene expressed in the brain or related to neural development. RVAS revealed 15 genes with a statistically significant (p-value = 5e-05) different burden of variants: DCP1B, OR12D2, PCDHA4, ALKBH8, NMUR2, OR52P1P, NEU1, CACNB2, PSMA7, LRR1, ZNF831, FSIP2, ZNF654, CES5A, and MPV17, several of which have known roles in neurodevelopment.

Conclusions: The identification of genes linked to amblyopia with roles in neurodevelopment suggests that the neurodevelopmental changes in amblyopia are not only secondary to abnormal visual experience but may result from the interaction of primary neurodevelopmental deficits with abnormal experience. This potentially explains why some children develop amblyopia and others do not with the same ocular risk factors, may explain differences in treatment outcomes, and suggests new avenues for amblyopia treatment.

Purpose: To describe the longitudinal changes in peripapillary retinal nerve fiber layer (pRNFL) and macular ganglion cell-inner plexiform layer (mGC-IPL) thicknesses in highly myopic eyes with and without glaucoma, and to investigate the effects of high myopia (HM) on the sectoral patterns of pRNFL and mGC-IPL thinning.

Design: Longitudinal cohort study.

Participants: A total of 243 eyes from 243 individuals with 3-year follow-up were included in this study: 109 eyes in the HM group, 64 eyes in the open-angle glaucoma (OAG) group and 70 eyes in the highly myopic glaucoma (HMG) group. Based on visual field assessment, 19 OAG eyes and 21 HMG eyes were determined to be progressive.

Methods: Mean and sectoral pRNFL and mGC-IPL thicknesses were obtained using swept-source optical coherence tomography. A linear mixed-effects model was used to compare the thinning rates and percentages between groups.

Main outcome measures: Mean and sectoral thinning rates and percentages of pRNFL and mGC-IPL in HM, OAG, and HMG eyes.

Results: The mean age of the participants was 37.2 ± 11.2 years, and the mean follow-up duration was 3.2 ± 0.3 years. The mean pRNFL thickness changed at rates of -0.44, -0.63 and -1.17 μm/year in the HM, OAG, and HMG group, respectively (P < 0.001), while the mean mGC-IPL thickness changed at rates of -0.10, -0.32 and -0.41 μm/year in the three groups, respectively (P < 0.001). Temporal pRNFL thinning was faster in HMG compared to OAG (-1.24 μm/year vs -0.45 μm/year, P = 0.002). The mGC-IPL thinning rate in each sector was not significantly different between HMG and OAG group (all Ps > 0.05). In contrast to OAG, HMG eyes showed greater percentage thinning rates of pRNFL in the inferior and temporal sectors, with a greater mGC-IPL thinning in the inferonasal sector.

Conclusions: The patterns of pRNFL and mGC-IPL thinning differ between HMG and OAG. In particular, faster temporal pRNFL thinning may serve as a distinguishing feature for identifying glaucoma in HM eyes. These findings may also enhance the understanding of the mechanisms of damage in HMG.

Objective: To investigate barriers to healthcare access and utilization among patients with noninfectious uveitis (NIU) across different racial and ethnic groups.

Design: Retrospective cross-sectional study.

Subjects: Participants diagnosed with chronic NIU in the nationwide All of Us Research Program.

Methods: We analyzed healthcare access and utilization (HCA&U) and social determinants of health (SDoH) surveys. Racial and ethnic groups were defined as non-Hispanic White, non-Hispanic Black, Hispanic, and 'Other'. Multivariable logistic regression models adjusted for age, sex, education, insurance type, and income were used to assess disparities.

Main outcome measures: Financial and non-financial disparities in healthcare access among racial and ethnic groups.

Results: Of 2,452 NIU patients, 810 (33%) responded to the HCA&U survey and 607 (24.7%) to the SDoH survey. Non-Hispanic Black participants reported significantly more experiences of being treated with less courtesy (adjusted odds ratio 2.6, 95% confidence interval [1.4- 5], p=0.003) and respect (2.6 [1.4- 4.8], p=0.003), as well as receiving poorer services (3.6 [1.9- 6.9], p<0.001) compared to Non-Hispanic White participants. Individuals categorized as 'Other' minorities were more likely to delay seeking medical care due to out-of-pocket costs (3.4 [1.6- 7.1], p=0.001) and concerns over medical bills (2 [1.05- 3.8], p=0.04). Additionally, they experienced significant delays in care due to living in rural areas with limited access to healthcare providers (7.1 [1.4-35.6], p=0.02).

Conclusions: Racial and ethnic minorities with NIU face significant barriers to healthcare utilization and quality, underscoring the need for targeted interventions to address disparities and improve health equity in uveitis management.

Purpose: To identify baseline clinical predictors of visual outcomes six months after acute optic neuritis using data from our completed clinical neuroprotection trial (TONE study).

Design: Secondary analysis of data from the TONE study cohort (NCT01962571).

Subjects: Total of 103 patients presenting within 10 days of a first episode of acute unilateral optic neuritis as a clinically isolated syndrome with baseline high contrast visual acuity (HCVA) < 20/40 Snellen (logMAR 0.3). Patients were recruited from 12 German university hospitals between November 25^th, 2014, and October 9th, 2017.

Methods: We selected potential predictors based on literature research and experience, then computed initial linear regression models that each included one predictor together with the baseline value of the outcome of interest. We used a forward-selection approach to build a multiple regression model for each outcome. Since the trial medication of the TONE study (erythropoietin) had no effect on the visual system, we used pooled (treatment-agnostic) data for all analyses.

Main outcome measures: Independent predictors of HCVA, low contrast letter acuity, visual-evoked potentials (VEP) P100 peak times, macular ganglion cell and inner plexiform layer thickness, and peripapillary retinal nerve fiber layer thickness at six months.

Results: On multiple regression, the most consistent predictors were higher baseline HCVA, which was associated with better outcomes across all measures except VEP conduction time; male sex, which predicted worse outcomes for all measures except HCVA; and older age, which was linked to poorer functional outcomes.

Conclusions: Patients who are older, male, and present with worse initial visual function may be at risk for worse clinical outcomes in acute optic neuritis. This knowledge may inform individual patient counselling, facilitate patient selection for time-sensitive and invasive immunomodulatory treatments, and can be used to ensure balanced risk characteristics in clinical neuroprotection trials.