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

Обзор

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.

Первичные конечные точки

• Limbal epithelial thickness [Срок оценки: Upon enrollment and at 6 months after enrollment (for newly diagnosed patients)]

Вторичные конечные точки (2)

• Corneal central epithelial thickness [Срок оценки: Upon enrollment and at 6 months after enrollment (for newly diagnosed patients)]
• Proteomic findings of tear samples [Срок оценки: Upon enrollment and at 6 months after enrollment (for newly diagnosed patients)]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Тайвань · 1 центр

• National Taiwan University Hospital Hsinchu Branch — Hsinchu

Идентификаторы

NCT: NCT07119580 · 202407137RINB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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