Fuchs DystrophyNCT04564378
Association Between Fuchs' Endothelial Corneal Dystrophy Severity and Estrogen Exposure
An observational study of Fuchs Dystrophy, run by State University of New York at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Fuchs Dystrophy
- What is being tested?
- This is an observational study. There is no therapeutic intervention.
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2018to 1 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Individuals with mild or severe Fuchs Dystrophy
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ira G. Ross Eye Institute
Buffalo, New York, 14209
About this study
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
- Being tested
- This is an observational study. There is no therapeutic intervention.
- Medical subject headings
- Fuchs' Endothelial Dystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is an observational study. There is no therapeutic intervention.Other
This is an observational study. There is no therapeutic intervention.
| Study group | Role | What they receive |
|---|---|---|
| Mild Fuchs Dystrophy | Not described Receives: Other: This is an observational study. There is no therapeutic intervention. | |
| Severe Fuchs Dystrophy | Not described Receives: Other: This is an observational study. There is no therapeutic intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association Between Fuchs endothelial Corneal Dystophy Severity and Estrogen Exposure
Difference in measures of estriadiol exposure between individuals with mild vs. severe FECD
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2020
- Study start17 Jan 2018
- Primary completion27 Apr 2023
- Study completion1 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fuchs DystrophyStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sangita Patel, State University of New York at Buffalo
- Investigators
- Sagita Patel, Principal investigator, The Ross Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04564378
- Sponsor's protocol ID
- STUDY00002020
- Status last verified
- Sep 2024
- First submitted
- 21 Sep 2020
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Petrela RB, Chhetri CD, Najafi A, Zhang Z, A Rinkoski T, Wieben ED, Fautsch MP, Chakraborty S, E Millen A, Patel SP. Associations between measures of oestrogen exposure and severity of Fuchs endothelial corneal dystrophy. BMJ Open Ophthalmol. 2025 May 14;10(1):e001884. doi: 10.1136/bmjophth-2024-001884.
PubMed 40374208
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Fuchs' Endothelial Corneal Dystrophy Severity and Estrogen Exposure
- ClinicalTrials.gov ID
- NCT04564378
- Acronym / sponsor ID
- STUDY00002020
- Conditions
- Fuchs Dystrophy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 27 Apr 2023 (actual)
- Study completion
- 1 Sep 2023 (actual)
- First posted
- 25 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with mild or severe Fuchs Dystrophy
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is an observational study. There is no therapeutic intervention.This is an observational study. There is no therapeutic intervention. | Other | Mild Fuchs Dystrophy, Severe Fuchs Dystrophy |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Derived from this study: PubMed 40374208Petrela RB, Chhetri CD, Najafi A, Zhang Z, A Rinkoski T, Wieben ED, Fautsch MP, Chakraborty S, E Millen A, Patel SP. Associations between measures of oestrogen exposure and severity of Fuchs endothelial corneal dystrophy. BMJ Open Ophthalmol. 2025 May 14;10(1):e001884. doi: 10.1136/bmjophth-2024-001884.
- Individual participant dataSharing planned: No
Related trials for Fuchs Dystrophy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sagita Patel principal investigator
The Ross Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fuchs Dystrophy, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between Fuchs endothelial Corneal Dystophy Severity and Estrogen Exposure (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04564378, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.