Meibomian Gland Changes in Ocular Prosthesis Users (MGPRO)

Evaluation of Meibomian Gland Loss and Dry Eye Symptoms in Ocular Prosthesis Users

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye; Anophthalmic Socket Syndrome; Ocular Prostheses; Meibomian Gland Dysfunction (Disorder)
• Intervention / Treatment: Diagnostic test: Oculus Keratograph 5M

Detailed Description

Loss of the eyeball and subsequent use of ocular prostheses have been associated with symptoms such as dryness, irritation, mucoid discharge, conjunctival hyperemia, and ocular discomfort. Meibomian gland dysfunction has been proposed as one of the mechanisms contributing to evaporative dry eye in anophthalmic socket patients. Chronic mechanical friction between the prosthesis and the tarsal conjunctiva, inflammation, and alterations of the ocular surface may induce glandular obstruction and atrophy.

This observational cross-sectional study evaluates morphological changes of the meibomian glands and dry eye symptoms in patients using unilateral ocular prostheses treated at the Oculoplastic Department of the Instituto de Oftalmología Fundación Conde de Valenciana, Mexico City, Mexico.

Adult patients with a history of enucleation or evisceration and at least 6 months of ocular prosthesis use are included. Each participant serves as their own control by comparing the prosthetic eye with the contralateral healthy eye.

Dry eye symptoms are assessed using the Dry Eye Questionnaire-5 (DEQ-5). Meibomian gland morphology, conjunctival hyperemia, and tear meniscus height are evaluated using the Oculus Keratograph 5M.

The primary objective is to determine the association between ocular prosthesis wear and meibomian gland loss. Secondary objectives include evaluating the association between prosthesis use and dry eye symptoms, conjunctival hyperemia, and tear meniscus alterations. The study also explores possible associations between prosthesis cleaning habits, duration of prosthesis use, and ocular surface findings.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico, 06800
    • ✔ Instituto de Oftalmología Fundación Conde de Valenciana IAP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Dry Eye Questionnaire-5 used to assess dry eye symptoms in prosthetic and healthy eyes.
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; Dry Eye Questionnaire-5 used to assess dry eye symptoms in prosthetic and healthy eyes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dry Eye Symptoms	Dry eye symptoms assessed using the Dry Eye Questionnaire-5 (DEQ-5) and compared between prosthetic eyes and contralateral healthy eyes.	At baseline
Conjunctival Hyperemia	Conjunctival hyperemia assessed using the Jenvis grading scale with the Oculus Keratograph 5M and compared between prosthetic eyes and contralateral healthy eyes.	At baseline

Collaborators and Investigators

• Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2023
• Primary Completion (Actual): July 25, 2024
• Study Completion (Actual): July 26, 2024

Study Registration Dates

• First Submitted: May 26, 2026
• First Submitted That Met QC Criteria: May 26, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: tear film; dry eye; Meibomian Gland Dysfunction; Meibography; Ocular Prostheses; Anophthalmic Socket
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Eyelid Diseases; Meibomian Gland Dysfunction; Dry Eye Syndromes
• Other Study ID Numbers: FCV-MGL-2023-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No