Clinical trial

Impact of GLP-1 Receptor Agonists on Dry Eye Disease in Patients With Type 2 Diabetes Mellitus and Obesity

Recruiting now · Not applicable · 1 countries · Registry ID NCT07605572

Recruiting nowNot applicableObservational

What this study is about

Diabetes mellitus (DM), prediabetes, and obesity are emerging as major global public health problems, with their epidemic spread continuously increasing over the past decades. The occurrence of diabetic retinopathy, cataract, glaucoma, and ocular surface disease in patients with diabetes mellitus has been extensively investigated in several studies. However, mild ocular surface disorders, such as dry eye disease, have often been overlooked, with a previous study showing that 51.3% of diabetes-related dry eye disease cases remained underdiagnosed. Among systemic diseases, diabetes mellitus and obesity have been associated with an increased risk of developing dry eye disease. Chronic hyperglycemia in diabetes leads to microvascular damage, including corneal neuropathy and reduced tear production, conditions that can disrupt ocular surface health, while systemic inflammation and meibomian gland dysfunction also contribute to this process. However, the effect of newer classes of antidiabetic medications, including glucagon-like peptide-1 receptor agonists (GLP-1 RAs), on ocular surface health remains insufficiently understood. The aim of this prospective cohort study is to evaluate the effects of GLP-1 receptor agonists on dry eye disease in patients with type 2 diabetes mellitus and obesity through the assessment of ocular surface parameters, such as tear film break-up time, Schirmer test results, as well as potential changes in corneal topography.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionDry Eye Disease (DED), Diabete Mellitus, GLP-1, Ocular Surface, Diabetes Type 2, Cornea

Full registry criteria

Inclusion Criteria: 1. Age ≥18 years. 2. Patients who have not previously received GLP-1 receptor agonists (GLP-1 RAs). 3. Patients able to provide informed consent for participation in the study. Exclusion Criteria: 1. Pregnant or breastfeeding patients. 2. History of multiple severe hypoglycemic episodes within the past two years. 3. Active intraocular inflammation in either eye, such as infectious conjunctivitis, keratitis, scleritis, endophthalmitis, or autoimmune uveitis. 4. Patients who have undergone cataract surgery or vitrectomy within the past 6 months. 5. History of ketoacidosis or metabolic acidosis. 6. History of corneal transplantation.

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

Changes in Ocular ParametersAll ophthalmological will be assessed at two time points: t0: Baseline assessment, before initiation of GLP-1 RA or GLP-1 RA/GIP therapy. t1: Follow-up assessment, 6-months after the intervention period, to evaluate changes ocular surface.

Change in Best-Corrected Visual Acuity (BCVA): Assessment of changes in best-corrected visual acuity (BCVA) using standardized Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity charts.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

2nd Department of Internal Medicine, Research Institute and Diabetes Center, National and Kapodistrian University of Athens, Athens, GRC.🇬🇷 Athens, Greece

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Vaia LambadiariContact

Email · Call (0030)2105832015