Association Between Fuchs' Endothelial Corneal Dystrophy Severity and Estrogen Exposure

Fuchs Dystrophy Clinical Trial

Official title:

Association Between Fuchs' Endothelial Corneal Dystrophy Severity and Estrogen Exposure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04564378
• Other study ID #: STUDY00002020
• Status: Active, not recruiting
• Start date: January 17, 2018
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2023
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 43
• Est. completion date: June 30, 2024
• Est. primary completion date: April 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Corneal Dystrophies, Hereditary
• Fuchs Dystrophy
• Fuchs' Endothelial Dystrophy

Locations

Country	Name	City	State
United States	The Ira G. Ross Eye Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Association Between Fuchs endothelial Corneal Dystophy Severity and Estrogen Exposure	Difference in measures of estriadiol exposure between individuals with mild vs. severe FECD	5 years