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

NCT07119580 | Recruiting

• 1 other identifier: 202407137RINB
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

Corneal epithelium; Limbal stem cells; Glaucoma; Tear fluid; Proteome

Outcome Measures

Primary Outcomes (1)

• Limbal epithelial thickness

  Limbal epithelial thickness obtained from AS-OCT

  Upon enrollment and at 6 months after enrollment (for newly diagnosed patients)

Secondary Outcomes (2)

• Corneal central epithelial thickness

  Upon enrollment and at 6 months after enrollment (for newly diagnosed patients)

• Proteomic findings of tear samples

  Upon enrollment and at 6 months after enrollment (for newly diagnosed patients)

Study Arms (4)

Healthy control

Healthy control, without diagnosis of glaucoma.

Glaucoma, newly diagnosed

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

Glaucoma, long-term medication use

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

Glaucoma, unilateral

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Glaucoma patients in outpatient clinic setting.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital Hsinchu Branch

Hsinchu, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tear fluid samples

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension; Limbal Stem Cell Deficiency

Condition Hierarchy (Ancestors)

Eye Diseases; Corneal Diseases

Central Study Contacts

Wei-Lun Huang, MD

CONTACT

886-3-6677600; weilunhuang@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 13, 2025
• Study Start: July 8, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 13, 2025

Record last verified: 2024-08

Locations

TW (1)