Skip to main content
OpenTrials
Completed

NCT Number: NCT04564378

Association Between Fuchs' Endothelial Corneal Dystrophy Severity and Estrogen Exposure

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fuchs Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Eye Diseases Eye Diseases, Hereditary Fuchs' Endothelial Dystrophy Genetic Diseases, Inborn

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Ira G. Ross Eye Institute

Buffalo, New York, 14209, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals with FECD grade 1-2/7 (mild) or 5-6/7 (severe) in one or both eyes
  • Age ≥ 55
  • 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

  • Females are excluded if not post-menopause.
  • 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.

Treatment and study plan

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

Other

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

Primary outcomes

  1. Association Between Fuchs endothelial Corneal Dystophy Severity and Estrogen Exposure

    Time frame: 5 years

    Difference in measures of estriadiol exposure between individuals with mild vs. severe FECD

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Sep 25, 2020
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.