Association Between Fuchs' Endothelial Corneal Dystrophy Severity and Estrogen Exposure

Completed

• Conditions: Fuchs Dystrophy
• Interventions: Other: This is an observational study. There is no therapeutic intervention.

• Registration Number: NCT04564378
• Lead Sponsor: State University of New York at Buffalo

Brief Summary

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

Not available

Study Timeline

• Study Start: 2018-01-17
• Study First Submitted: 2020-09-21
• Study First Submitted QC: 2020-09-21
• Study First Posted: 2020-09-25
• Primary Completion: 2023-04-27
• Study Completion: 2023-09-01
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mild Fuchs Dystrophy	This is an observational study. There is no therapeutic intervention.	-
Severe Fuchs Dystrophy	This is an observational study. There is no therapeutic intervention.	-

Primary Outcome Measures

Name	Time	Method
Association Between Fuchs endothelial Corneal Dystophy Severity and Estrogen Exposure	5 years	Difference in measures of estriadiol exposure between individuals with mild vs. severe FECD

Trial Locations

Locations (1)

The Ira G. Ross Eye Institute; 🇺🇸 Buffalo, New York, United States