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Clinical Trials/NCT07605572
NCT07605572RecruitingNot Applicable

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

Attikon Hospital1 site in 1 country100 target enrollmentStarted: March 1, 2026Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
100
Locations
1

Study Overview

Brief Summary

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.

Detailed Description

This prospective cohort study aims to shed a light to the effects of GLP-1 RAs on Dry Eye Disease in Patients with Type 2 Diabetes Mellitus and Obesity.

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.
  • Patients who have not previously received GLP-1 receptor agonists (GLP-1 RAs).
  • Patients able to provide informed consent for participation in the study.

Exclusion Criteria

  • Pregnant or breastfeeding patients.
  • History of multiple severe hypoglycemic episodes within the past two years.
  • Active intraocular inflammation in either eye, such as infectious conjunctivitis, keratitis, scleritis, endophthalmitis, or autoimmune uveitis.
  • Patients who have undergone cataract surgery or vitrectomy within the past 6 months.
  • History of ketoacidosis or metabolic acidosis.
  • History of corneal transplantation.

Investigators

Sponsor
Attikon Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

VAIA LAMBADIARI

Vaia Lambadiari, Professor of Internal Medicine, University of Athens

University of Athens

Study Sites (1)

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