Investigating eye and tear film changes in Chinese patients with Type 2 diabetes
Corneal and Tear Film Changes in Chinese Patients With Type 2 Diabetes: a Cross-sectional Controlled Study
This study is testing how Type 2 diabetes affects eye health and tear production in patients compared to people without diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | He Eye Hospital Academic / other |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT06218992 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the clinical and inflammatory changes in the ocular surface of insulin-independent Type 2 diabetic patients. It will recruit 200 diabetic patients and 200 age- and sex-matched controls without diabetes to assess the impact of diabetes on dry eye disease (DED). The study will evaluate various parameters such as tear film stability, corneal thickness, and nerve integrity, which are crucial for understanding the ocular surface health in this population. The findings could provide insights into the mechanisms of ocular surface damage associated with diabetes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with dry eye disease and Type 2 diabetes.
Not a fit: Patients with active ocular infections, a history of ocular surgeries, or other ocular diseases that could affect the corneal or tear film may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of dry eye disease in diabetic patients.
How similar studies have performed: Previous studies have indicated associations between diabetes and ocular surface dysfunction, but this specific investigation in the Chinese population is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants are diagnosed with dry eye according to the TFOS DEWS II diagnostic criteria: (a) OSDI questionnaire ≥13, (b) Non-invasive tear breakup time (NITBUT) \<10 s, (c) ocular surface staining \>5 corneal spots, greater than nine conjunctival spots (The presence of two or more criteria was used to establish a positive DE diagnosis). * Age ≥ 18 Exclusion Criteria: * Active ocular infection, such as infectious, viral, chlamydial, or immunologic conjunctivitis * A history of ocular surgery that might affect the corneal or tear film, such as corneal refractive surgery, keratoplasty, cataract surgery, or ocular laser surgery * Long-term contact lens wear * Other ocular diseases being treated might affect the corneal or tear film: such as glaucoma, dacryocystitis, uveitis, and pterygium.
Where this trial is running
Shenyang, Liaoning
- He Eye Hospital — Shenyang, Liaoning, China (Recruiting)
Study contacts
- Study coordinator: Guanghao Qin
- Email: qinguanghao@hsyk.com.cn
- Phone: +8618842664420
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.