✔ Instituto de Oftalmología Fundación Conde de Valenciana IAP
Mexico City, 06800, Mexico
NCT Number: NCT07621952
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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Notify Me18 year and older
All sexes
Observational
Mexico City, 06800, Mexico
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dry Eye Questionnaire-5 used to assess dry eye symptoms in prosthetic and healthy eyes.
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.
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.
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.
Instituto de Oftalmología Fundación Conde de Valenciana
Other
Evaluation of Meibomian Gland Loss and Dry Eye Symptoms in Ocular Prosthesis Users
Acronym: MGPRO
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