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CompletedNCT04564378Updated Oct 1, 2024

Association Between Fuchs' Endothelial Corneal Dystrophy Severity and Estrogen Exposure

An observational study in Fuchs Dystrophy, sponsored by State University of New York at Buffalo. Completed at 1 site in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2024-10-01.

Sponsored by State University of New York at Buffalo · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
43
Ages
55 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Fuchs Dystrophy
03

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Individuals with mild or severe Fuchs Dystrophy

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

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.
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Study design

Observational model
Other
Time perspective
Other
Enrollment
43 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherThis is an observational study. There is no therapeutic intervention.

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

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What researchers measure

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

    Time frame: 5 years

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Study locations

1 site
  • The Ira G. Ross Eye Institute
    Buffalo, New York 14209, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT04564378
Lead sponsor
State University of New York at Buffalo
Responsible party
Sangita Patel (Assistant Professor, State University of New York at Buffalo) — Principal investigator
First posted
Sep 25, 2020
Start date
Jan 17, 2018
Primary completion
Apr 27, 2023
Completion
Sep 1, 2023
Last update
Oct 1, 2024

Study contacts

Sagita Patel
principal investigator · The Ross Eye Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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