Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) in Non-Diabetic Obese Patients Using Glucagon-Like Peptide-1 Receptor Agonists: A Retrospective Real-World Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Occurrence of NAION
Study Overview
Brief Summary
Non-arteritic anterior ischemic optic neuropathy (NAION) is one of the most common causes of sudden, painless, usually unilateral vision loss in adults over 50 years of age, and no proven effective treatment exists. Glucagon-like peptide-1 receptor agonists (GLP-1 RA), such as semaglutide and tirzepatide, are widely used for type 2 diabetes and obesity. Since 2023, case series, cohort studies and regulatory reviews have raised the possibility of an association between semaglutide and NAION, but published evidence is conflicting, and data in non-diabetic obese patients are limited.
This retrospective, single-center, descriptive real-world study will review the existing records of non-diabetic obese adults (BMI > 30) who used a GLP-1 RA and attended the ophthalmology outpatient clinic between January 2025 and February 2026 with at least two eye examinations. The aim is to describe the occurrence and time-related change of NAION and related ophthalmic findings in this population.
Detailed Description
Background and rationale: NAION results from impaired perfusion of the optic nerve head, and risk is increased by type 2 diabetes, hypertension, sleep apnea and a small optic disc ("disc at risk"). Proposed mechanisms linking GLP-1 RA to NAION include rapid glycemic and weight change affecting optic nerve perfusion autoregulation, direct effects through GLP-1 receptors present in the retinal ganglion cell layer, and nocturnal hypotension. Studies that examine GLP-1 RA use and NAION together in non-diabetic obese patients were not identified in the literature review by the investigators.
Design: Retrospective descriptive study. Data will be collected by the investigators from the hospital information system; no new examination, parameter or intervention will be requested from patients. Data collection is planned from 30 May 2026 to 30 November 2026, after ethics committee and hospital approval.
Data collected: Age, education level, smoking, alcohol use, weight, height and BMI; ophthalmic findings including Snellen visual acuity, biomicroscopic anterior segment examination, intraocular pressure, fundus examination, direct/indirect light reflex, and retinal nerve fiber layer thickness measured by OCT. Data are recorded on a Descriptive Information Form developed by the investigators.
Sample size: Because no sampling will be performed, all patients meeting the criteria will be included. A power analysis using proportions of 0.38 and 0.09 from previous studies (95% confidence, alpha 0.05, 80% power) gave a required sample of 28 participants.
Statistical analysis: IBM SPSS 26.0. Descriptive statistics (number, percentage, mean, standard deviation); normality by Shapiro-Wilk test, skewness and kurtosis; t-test and/or Mann-Whitney U for two-group comparisons; ANOVA and/or Kruskal-Wallis H for three or more groups; correlation and/or chi-square analysis for associations. Significance level p < 0.05 with 95% confidence interval.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 years or older
- •Diagnosis of obesity (body mass index > 30)
- •No hearing, speech or cognitive impairment
- •Not receiving treatment for major depressive disorder and not using antidepressant medication
- •At least two eye examinations with measurements on record
- •Verbal agreement to participate
Exclusion Criteria
- •Diagnosis of diabetes
- •Diagnosis of hypertension
- •Previous optic neuritis or similar eye disease
- •Optic disc drusen, optic disc anomaly, glaucoma or other disease involving the optic nerve
- •High hyperopia or small, crowded optic disc
- •Not meeting the inclusion criteria or not willing to participate
Arms & Interventions
GLP-1 RA users (non-diabetic, obese)
Adults aged 18 or older with BMI > 30 and no diabetes diagnosis, who used a GLP-1 receptor agonist and had at least two ophthalmic examinations with measurements at the clinic between January 2025 and February 2026.
Intervention: GLP-1 Receptor Agonist Therapy (Drug)
Outcomes
Primary Outcomes
Occurrence of NAION
Time Frame: Baseline (GLP-1 RA initiation) to final recorded eye examination, up to 14 months
Number and percentage of participants with a NAION diagnosis recorded in the ophthalmic examination records.
Secondary Outcomes
- • Change in visual acuity (Snellen chart) between the first and last recorded examination(Baseline (GLP-1 RA initiation) to final recorded eye examination, up to 14 months)
Investigators
GÜLDEN ANATACA
MsD,RN
Istanbul Saglik Bilimleri University