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Association Between Fuchs' Endothelial Corneal Dystrophy Severity and Estrogen Exposure

Sponsor
State University of New York at Buffalo (Other)
Overall Status
Recruiting
CT.gov ID
NCT04564378
Collaborator
(none)
130
Enrollment
1
Location
65.4
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    130 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    Association Between Fuchs' Endothelial Corneal Dystrophy Severity and Estrogen Exposure
    Actual Study Start Date :
    Jan 17, 2018
    Anticipated Primary Completion Date :
    Jun 30, 2023
    Anticipated Study Completion Date :
    Jun 30, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Mild Fuchs Dystrophy
    Severe Fuchs Dystrophy

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Ira G. Ross Eye Institute Buffalo New York United States 14209

    Sponsors and Collaborators

    • State University of New York at Buffalo

    Investigators

    • Principal Investigator: Sagita Patel, The Ross Eye Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sangita Patel, Assistant Professor, State University of New York at Buffalo
    ClinicalTrials.gov Identifier:
    NCT04564378
    Other Study ID Numbers:
    • STUDY00002020
    First Posted:
    Sep 25, 2020
    Last Update Posted:
    Apr 5, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Corneal Dystrophies, Hereditary
    Fuchs' Endothelial Dystrophy

    Study Results

    No Results Posted as of Apr 5, 2022