Meibomian Gland Changes in Ocular Prosthesis Users (MGPRO)
Evaluation of Meibomian Gland Loss and Dry Eye Symptoms in Ocular Prosthesis Users
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Mexico City、墨西哥、06800
- ✔ Instituto de Oftalmología Fundación Conde de Valenciana IAP
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
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
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Meibomian Gland Loss
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Dry Eye Symptoms
大体时间: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
大体时间: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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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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