Association Between Fuchs' Endothelial Corneal Dystrophy Severity and Estrogen Exposure

NCT ID: NCT04564378

Last Updated: 2024-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-17

Study Completion Date

2023-09-01

Brief Summary

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This study is being done to discover if there is a link between estrogen exposure and the severity of Fuchs Endothelial Corneal Disease. We are trying to understand if the decrease in estrogen levels in post-menopausal women may be a reason why FECD is seen more often in women than men.

Detailed Description

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Conditions

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Fuchs Dystrophy

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Mild Fuchs Dystrophy

This is an observational study. There is no therapeutic intervention.

Intervention Type OTHER

This is an observational study. There is no therapeutic intervention.

Severe Fuchs Dystrophy

This is an observational study. There is no therapeutic intervention.

Intervention Type OTHER

This is an observational study. There is no therapeutic intervention.

Interventions

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This is an observational study. There is no therapeutic intervention.

This is an observational study. There is no therapeutic intervention.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Individuals with FECD grade 1-2/7 (mild) or 5-6/7 (severe) in one or both eyes
2. Age ≥ 55
3. Phakic and pseudophakic individuals will be included. Pseudophakic patients must have evidence of routine cataract surgery (posterior chamber intraocular lens in-the-bag without clinical evidence of damage to any intraocular structures).

Exclusion Criteria

1. Females are excluded if not post-menopause.
2. Pseudophakic patients with a history of complex cataract surgery or other intraocular surgery (e.g. have an anterior chamber lens, sulcus lens, or poorly positioned posterior chamber lens, aphakia, iris damage, glaucoma surgery) will be excluded due to risk of iatrogenic damage to the corneal endothelium.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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State University of New York at Buffalo

OTHER

Sponsor Role lead

Responsible Party

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Sangita Patel

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sagita Patel

Role: PRINCIPAL_INVESTIGATOR

The Ross Eye Institute

Locations

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The Ira G. Ross Eye Institute

Buffalo, New York, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00002020

Identifier Type: -

Identifier Source: org_study_id

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