Impact of GLP-1 Receptor Agonists on Dry Eye Disease in Patients With Type 2 Diabetes Mellitus and Obesity
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAttikon Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
The diagnosis of diabetes mellitus will be established according to the diagnostic criteria defined by the European Association for the Study of Diabetes (EASD), the American Diabetes Association (ADA), and the European Association for the Study of Obesity (EASO). Male and/or female patients attending the regular outpatient ophthalmology clinics, with stable refraction over the past two years, without pathological corneal findings (including corneal ulcer, keratoconus, corneal dystrophies, corneal trauma/abrasions), no history of corneal infections during the last 2 years, and no history of refractive surgery will be included. To ensure the objectivity of the results, the assessment of dry eye disease parameters will be performed by an ophthalmologist blinded to the patient's study group allocation (single-blinded design), thereby minimizing the possibility of observer bias during data collection.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 2 trial groupsGroup A: Group A
Group B: Group B
Trial outcomes
Primary outcomes
1
Changes in Ocular Parameters
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.
Time frame
All 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.Secondary outcomes
1
Change in Tear Film Break-Up Time (BUT)
Change in Tear Film Break-Up Time (BUT): Assessment of changes from baseline in tear film break-up time (BUT), measured in seconds (s), as an indicator of tear film stability and ocular surface function.
Time frame
All 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.2
Change in Tear Meniscus Height (TMH)
Change in Tear Meniscus Height (TMH): Assessment of changes from baseline in tear meniscus height (TMH), measured in millimeters (mm), as an indicator of tear volume and ocular surface function.
Time frame
All 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.Sponsors and contacts
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Attikon Hospital
Lead sponsor
University of Athens
Sponsor institution
Source ClinicalTrials.gov