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Meibomian Gland Changes in Ocular Prosthesis Users

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07621952
Acronym
MGPRO
Enrollment
20
Registered
2026-06-02
Start date
2023-08-18
Completion date
2024-07-26
Last updated
2026-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

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.

Interventions

DIAGNOSTIC_TESTOculus Keratograph 5M

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

Sponsors

Instituto de Oftalmología Fundación Conde de Valenciana
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Dry Eye SymptomsAt baselineDry eye symptoms assessed using the Dry Eye Questionnaire-5 (DEQ-5) and compared between prosthetic eyes and contralateral healthy eyes.
Conjunctival HyperemiaAt baselineConjunctival hyperemia assessed using the Jenvis grading scale with the Oculus Keratograph 5M and compared between prosthetic eyes and contralateral healthy eyes.

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 3, 2026