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Search / Trial NCT06218992

Corneal and Tear Film Changes in Chinese Patients With Type 2 Diabetes

Launched by HE EYE HOSPITAL · Jan 22, 2024

Trial Information

Current as of November 13, 2025

Recruiting

Keywords

Dry Eye Tear Film

ClinConnect Summary

This clinical trial is studying how diabetes affects the eyes, specifically looking at changes in the cornea (the clear front part of the eye) and tear film in Chinese patients with Type 2 Diabetes. The researchers want to understand how diabetes may cause problems like dry eye disease, which can make your eyes feel uncomfortable or irritated. To do this, they will compare 200 patients with Type 2 Diabetes who have dry eyes to 200 people of the same age and gender who do not have diabetes.

To participate in this study, you need to be at least 18 years old and diagnosed with dry eye disease based on specific criteria, like answering certain questions about your eye comfort and having particular test results. However, if you have an active eye infection, have had recent eye surgery, or wear contact lenses regularly, you may not be eligible to join. Participants can expect to undergo eye examinations and tests to assess their eye health. This study is currently recruiting participants, and your involvement could help improve understanding of how diabetes impacts eye health.

Gender

ALL

Eligibility 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.

About He Eye Hospital

The Eye Hospital is a leading clinical research institution dedicated to advancing the field of ophthalmology through innovative clinical trials and cutting-edge research. With a commitment to improving patient outcomes and enhancing vision health, the hospital collaborates with renowned experts and utilizes state-of-the-art technology to explore new therapies and treatment modalities. By prioritizing patient care and safety, The Eye Hospital plays a pivotal role in translating scientific discoveries into effective clinical practices, thereby contributing significantly to the global understanding of eye diseases and their management.

Locations

Shenyang, Liaoning, China

Patients applied

0 patients applied

Trial Officials

Guanghao Qin

Study Chair

He Eye Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported