Association Between Limbal Function and Tear Proteomics in Chronic Ocular Diseases: Focusing on Glaucoma

NCT ID: NCT07119580

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-08
• Study Completion Date: 2026-12-31

Brief Summary

Background Intact corneal epithelium is important for the defense on the ocular surface, and the function of limbal stem cells is crucial to maintain its integrity. Certain chronic eye diseases, such as glaucoma, require long-term medication use. However, glaucoma patients often exhibit corneal punctate erosions and ocular surface inflammation. In cases where medication has been used for an extended period, patients may even show symptoms similar to limbal stem cell deficiency. Understanding how glaucoma medications affect the function of corneal limbal stem cells is a critical clinical issue.

Objectives To evaluate the effect of glaucoma and anti-glaucoma agents on corneal epithelial and limbal epithelial thickness as a surrogate of limbal stem cell function, and to understand the association between tear fluid proteome and limbal function in glaucoma patients.

Methods We planned to include 90 subjects with glaucoma, and analyze the absolute thickness and variation of corneal epithelium and limbal epithelium. Tear fluid samples will be collected and proteomic analysis will be performed to elucidate the association between protein.

Anticipated Results To elucidate the impact of different types and cumulative doses of glaucoma medications on the thickness of the corneal epithelium and limbal epithelium, and to understand the relationship between limbal function and tear proteomics in glaucoma patients. The expected results may help develop early detection methods for changes in corneal and limbal epithelial function and provide valuable insights for future research on drug design and the protection of limbal stem cells.

Conditions

Glaucoma; Ocular Hypertension; Limbal Stem Cell Deficiency

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy control

Healthy control, without diagnosis of glaucoma.

No interventions assigned to this group

Glaucoma, newly diagnosed

Glaucoma patients who received topical antiglaucoma medications for less than 3 months.

No interventions assigned to this group

Glaucoma, long-term medication use

Glaucoma patients, received topical antiglaucoma medications for 1 year or longer.

No interventions assigned to this group

Glaucoma, unilateral

Patients with unilateral glaucoma or ocular hypertension and received treatment only in the diseased eye.

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

National Taiwan University Clinical Trial Center

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Taiwan University Hospital Hsinchu Branch

Hsinchu, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Wei-Lun Huang, MD

Role: CONTACT

weilunhuang@ntu.edu.tw

886-3-6677600 ext. 532267

Facility Contacts

Wei-Lun Huang, MD

Role: primary

weilunhuang@ntu.edu.tw

+886-3-6677600 ext. 532267

Other Identifiers

202407137RINB

Identifier Type: -

Identifier Source: org_study_id