Association Between Fuchs' Endothelial Corneal Dystrophy Severity and Estrogen Exposure

NCT04564378 | Completed

• 1 other identifier: STUDY00002020
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Fuchs Dystrophy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Mild Fuchs Dystrophy

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

Severe Fuchs Dystrophy

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

Interventions

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

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

Mild Fuchs Dystrophy; Severe Fuchs Dystrophy

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with mild or severe Fuchs Dystrophy

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

The Ira G. Ross Eye Institute

Buffalo, New York, 14209, United States

Location

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Sagita Patel

  The Ross Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: September 25, 2020
• Study Start: January 17, 2018
• Primary Completion: April 27, 2023
• Study Completion: September 1, 2023
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)