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Completed

NCT Number: NCT07621952

Meibomian Gland Changes 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

✔ Instituto de Oftalmología Fundación Conde de Valenciana IAP

Mexico City, 06800, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oculus Keratograph 5M

Diagnostic Test

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

Primary outcomes

  1. Meibomian Gland Loss

    Time frame: At baseline

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

Secondary outcomes

  1. Dry Eye Symptoms

    Time frame: At baseline

    Dry eye symptoms assessed using the Dry Eye Questionnaire-5 (DEQ-5) and compared between prosthetic eyes and contralateral healthy eyes.

  2. Conjunctival Hyperemia

    Time frame: At baseline

    Conjunctival hyperemia assessed using the Jenvis grading scale with the Oculus Keratograph 5M and compared between prosthetic eyes and contralateral healthy eyes.

Sponsors and collaborators

Lead sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Other

Registry information

Official study title

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

Acronym: MGPRO

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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