Meibomian Gland Changes in Ocular Prosthesis Users

NCT07621952 | Completed

• 1 other identifier: FCV-MGL-2023-01
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This observational cross-sectional study aims to evaluate meibomian gland loss and dry eye symptoms in patients using unilateral ocular prostheses. The study compares the prosthetic eye with the contralateral healthy eye using the DEQ-5 questionnaire and meibography obtained with the Oculus Keratograph 5M. Additional ocular surface parameters, including conjunctival hyperemia and tear meniscus height, are also evaluated. The objective is to determine whether ocular prosthesis wear is associated with morphological changes in the meibomian glands and increased dry eye symptoms.

Conditions

Anophthalmic Socket Syndrome; Ocular Prostheses; Dry Eye; Meibomian Gland Dysfunction (Disorder)

Keywords

dry eye; Ocular Prostheses; tear film; Meibography; Meibomian Gland Dysfunction; Anophthalmic Socket

Outcome Measures

Primary Outcomes (1)

• Meibomian Gland Loss

  Meibomian gland loss in the upper eyelid assessed by meibography using the Oculus Keratograph 5M and compared between prosthetic eyes and contralateral healthy eyes.

  At baseline

Secondary Outcomes (2)

• Dry Eye Symptoms

  At baseline

• Conjunctival Hyperemia

  At baseline

Study Arms (2)

Prosthetic Eye

Eyes with ocular prostheses in patients with unilateral anophthalmic socket. Meibomian gland morphology, dry eye symptoms, conjunctival hyperemia, and tear meniscus height were evaluated.

Diagnostic Test: Oculus Keratograph 5M

Healthy Contralateral Eye

Contralateral healthy eyes of the same patients used as controls for comparison of ocular surface and meibomian gland findings.

Diagnostic Test: Oculus Keratograph 5M

Interventions

Oculus Keratograph 5M DIAGNOSTIC_TEST

Dry Eye Questionnaire-5 used to assess dry eye symptoms in prosthetic and healthy eyes.

Healthy Contralateral Eye; Prosthetic Eye

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with unilateral ocular prostheses evaluated at the Oculoplastic Department of the Instituto de Oftalmología Fundación Conde de Valenciana, Mexico City, Mexico. Participants had a history of enucleation or evisceration and at least 6 months of ocular prosthesis use.

You may qualify if:

• Adults aged 18 years or older
• History of unilateral enucleation or evisceration
• Use of an ocular prosthesis for at least 6 months
• No use of topical ophthalmic medications within 1 month prior to evaluation
• Ability to complete ocular surface evaluation and questionnaires

You may not qualify if:

• Presence of orbital cavity infection
• Bilateral ocular prosthesis users
• Presence of ectropion or entropion
• Autoimmune diseases associated with ocular surface alterations

Sponsors & Collaborators

• Instituto de Oftalmología Fundación Conde de Valenciana: lead

Study Sites (1)

✔ Instituto de Oftalmología Fundación Conde de Valenciana IAP

Mexico City, 06800, Mexico

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Eyelid Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2026
• First Posted: June 2, 2026
• Study Start: August 18, 2023
• Primary Completion: July 25, 2024
• Study Completion: July 26, 2024
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)