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Association Between Fuchs' Endothelial Corneal Dystrophy Severity and Estrogen Exposure

Association Between Fuchs' Endothelial Corneal Dystrophy Severity and Estrogen Exposure

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04564378
Enrollment
43
Registered
2020-09-25
Start date
2018-01-17
Completion date
2023-09-01
Last updated
2024-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fuchs Dystrophy

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.

Interventions

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

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

Sponsors

State University of New York at Buffalo
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Association Between Fuchs endothelial Corneal Dystophy Severity and Estrogen Exposure5 yearsDifference in measures of estriadiol exposure between individuals with mild vs. severe FECD

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026