Impact of GLP-1 Receptor Agonists on Dry Eye Disease in Patients With Type 2 Diabetes Mellitus and Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Dry Eye Disease (DED), Diabete Mellitus, GLP-1, Ocular Surface. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Changes in Ocular Parameters [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 outcome measures (2)
- Change in Tear Film Break-Up Time (BUT) [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.]
- Change in Tear Meniscus Height (TMH) [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.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Greece · 1 center
- 2nd Department of Internal Medicine, Research Institute and Diabetes Center, National and — Athens
Publications
- Yamanishi R, Sawada N, Hanyuda A, Uchino M, Kawashima M, Yuki K, Tsubota K, Kato T, Saito I, Arima K, Mizukami S, Tanno K, Sakata K, Yamagishi K, Iso H, Yasuda N, Shimazu T, Yamaji T, Goto A, Inoue M, Iwasaki M, Tsugane S; JPHC-NEXT Group. Relation Between Body Mass Index and Dry Eye Disease: The Japan Public Health Center-Based Prospective Study for the Next Generation. Eye Contact Lens. 2021 Aug PMID 34310488
Identifiers
NCT: NCT07605572 · 193-16/02/2026