Limbal function and tear protein changes in glaucoma
Association Between Limbal Function and Tear Proteomics in Chronic Ocular Diseases: Focusing on Glaucoma
This study tests whether glaucoma and long-term glaucoma medicines change limbal stem cell–related corneal epithelial thickness and tear proteins in people with glaucoma, ocular hypertension, or healthy adults.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Hsinchu) |
| Trial ID | NCT07119580 on ClinicalTrials.gov |
What this trial studies
This is an observational study enrolling about 90 participants divided into healthy controls, newly diagnosed glaucoma/ocular hypertension (medication <3 months), long-term treated patients (medication >1 year), and unilateral cases. Investigators will measure corneal epithelial and limbal epithelial thickness as a surrogate for limbal stem cell function and collect tear fluid for proteomic analysis. The goal is to link structural changes at the limbus with specific changes in the tear proteome associated with disease and medication exposure. Standard exclusion criteria remove eyes with prior corneal/conjunctival surgery, severe ocular surface disease, or other conditions that would confound measurements.
Who should consider this trial
Good fit: Adults aged 18 or older who are healthy controls or have glaucoma/ocular hypertension, including newly diagnosed patients (meds <3 months), long-term treated patients (meds >1 year), or unilateral cases, are the intended participants.
Not a fit: Patients with prior corneal or conjunctival surgery, severe ocular surface disorders (e.g., chemical burns, Stevens-Johnson syndrome with ocular involvement), or other listed exclusion criteria are unlikely to benefit from or be eligible for this study.
Why it matters
Potential benefit: If successful, this work could identify tear-protein markers and structural signs that help clinicians detect medication-related limbal dysfunction earlier and tailor treatments to protect the ocular surface.
How similar studies have performed: Previous studies have shown tear-proteome changes in ocular surface disease and with medication exposure, but combining limbal epithelial thickness measurements with detailed tear proteomics specifically in glaucoma is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: i. Age ≥ 18 years. ii. Healthy Control Group: No diagnosis of glaucoma or ocular hypertension. iii. Glaucoma, Newly Diagnosed Group: Diagnosed with angle-closure glaucoma, open-angle glaucoma, or ocular hypertension; antiglaucoma medication usage for less than 3 months. iv. Glaucoma, Long-term Medication Group: Diagnosed with angle-closure glaucoma, open-angle glaucoma, or ocular hypertension; continuous use of intraocular pressure-lowering medications for more than 1 year. v. Glaucoma, Unilateral Group: Diagnosed with unilateral glaucoma or ocular hypertension; only one eye receiving intraocular pressure-lowering treatment. Exclusion Criteria: i. History of severe ocular trauma, chemical burns, corneal ulcers, Stevens-Johnson syndrome with ocular involvement, or ocular graft-versus-host disease. ii. History of corneal surgery, conjunctival surgery, trabeculectomy, or glaucoma drainage device implantation. iii. Presence of ocular surface irregularity or limbal dysfunction due to conditions other than glaucoma or dry eye disease.
Where this trial is running
Hsinchu
- National Taiwan University Hospital Hsinchu Branch — Hsinchu, Taiwan (Recruiting)
Study contacts
- Study coordinator: Wei-Lun Huang, MD
- Email: weilunhuang@ntu.edu.tw
- Phone: 886-3-6677600
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.