- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04564378
Association Between Fuchs' Endothelial Corneal Dystrophy Severity and Estrogen Exposure
August 22, 2023 updated by: Sangita Patel, State University of New York at Buffalo
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.
Study Overview
Status
Active, not recruiting
Conditions
Study Type
Observational
Enrollment (Actual)
43
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sharon Michalovic
- Phone Number: 716-881-7975
- Email: sab1@buffalo.edu
Study Contact Backup
- Name: Sangita Patel
- Phone Number: 716-881-7900
- Email: sppatel@buffalo.edu
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14209
- The Ira G. Ross Eye Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
53 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Individuals with mild or severe Fuchs Dystrophy
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
---|
Mild Fuchs Dystrophy
|
Severe Fuchs Dystrophy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sagita Patel, The Ross Eye Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 17, 2018
Primary Completion (Actual)
April 27, 2023
Study Completion (Estimated)
June 30, 2024
Study Registration Dates
First Submitted
September 21, 2020
First Submitted That Met QC Criteria
September 21, 2020
First Posted (Actual)
September 25, 2020
Study Record Updates
Last Update Posted (Actual)
August 24, 2023
Last Update Submitted That Met QC Criteria
August 22, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00002020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fuchs Dystrophy
-
Price Vision GroupCompletedBullous Keratopathy | Fuchs' DystrophyUnited States, Germany
-
Medical College of WisconsinCompletedCataract | Fuchs' Corneal DystrophyUnited States
-
Kowa Research Institute, Inc.CompletedFuchs' Endothelial Corneal DystrophyUnited States, Australia, Germany, Spain, Denmark
-
Massachusetts Eye and Ear InfirmaryRecruitingFuchs' Endothelial Corneal DystrophyUnited States
-
Stanford UniversityUniversity of Pennsylvania; University of California, Davis; Oregon Health and... and other collaboratorsRecruitingFuchs' Endothelial Dystrophy | Fuchs Dystrophy | FuchsUnited States
-
Trefoil Therapeutics, Inc.CompletedFuchs' Endothelial Dystrophy | Fuchs Dystrophy | FuchsUnited States
-
Cornea Research Foundation of AmericaCompletedCorneal Edema | Fuchs' DystrophyUnited States
-
Legacy Health SystemDevers Eye Institute; Lions Eye Bank of Oregon Vision Research Laboratory; Fischer...UnknownFuchs' Corneal Endothelial DystrophyUnited States
-
Cornea Research Foundation of AmericaCompletedBullous Keratopathy | Fuchs' Endothelial Corneal Dystrophy | Iridocorneal Endothelial Syndrome | Posterior Polymorphous DystrophyUnited States
-
Kowa Research Institute, Inc.RecruitingFuchs Endothelial Corneal DystrophyGermany, United States, Spain, Canada, United Kingdom, Denmark