Meibomian Gland Changes in Ocular Prosthesis Users (MGPRO)
Evaluation of Meibomian Gland Loss and Dry Eye Symptoms in Ocular Prosthesis Users
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Mexico City, Mexico, 06800
- ✔ Instituto de Oftalmología Fundación Conde de Valenciana IAP
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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.
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Dry Eye Questionnaire-5 used to assess dry eye symptoms in prosthetic and healthy eyes.
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Healthy Contralateral Eye
Contralateral healthy eyes of the same patients used as controls for comparison of ocular surface and meibomian gland findings.
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Dry Eye Questionnaire-5 used to assess dry eye symptoms in prosthetic and healthy eyes.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Meibomian Gland Loss
Tidsramme: At baseline
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Meibomian gland loss in the upper eyelid assessed by meibography using the Oculus Keratograph 5M and compared between prosthetic eyes and contralateral healthy eyes.
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At baseline
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Dry Eye Symptoms
Tidsramme: At baseline
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Dry eye symptoms assessed using the Dry Eye Questionnaire-5 (DEQ-5) and compared between prosthetic eyes and contralateral healthy eyes.
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At baseline
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Conjunctival Hyperemia
Tidsramme: At baseline
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Conjunctival hyperemia assessed using the Jenvis grading scale with the Oculus Keratograph 5M and compared between prosthetic eyes and contralateral healthy eyes.
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At baseline
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FCV-MGL-2023-01
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