Fuchs DystrophyNCT04258787
OCT in Fuchs' Dystrophy
An observational study of Fuchs Dystrophy and Pseudophakic Bullous Keratopathy, run by Oregon Health and Science University at 1 site in United States.
Trial summary
This is an observational study using optical coherence tomography (OCT) technology to quantify corneal edema in Fuchs' endothelial dystrophy and predict refractive shift from resolving corneal edema after surgical treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fuchs Dystrophy, Pseudophakic Bullous Keratopathy
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2020to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults age 18 or older with Fuchs' or PBK
Who may be able to join
- Damaged or diseased corneal endothelium from Fuchs' or PBK
- Willingness to commit to required study visits
Who cannot join
- Prior Endothelial Keratoplasty (EK) or any other surgery except uncomplicated cataract surgery
- Presence of a condition that increases the probability for treatment failure (e.g., heavily vascularized cornea, uncontrolled uveitis)
- Other primary endothelial dysfunction conditions (e.g., posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy, iridocorneal endothelial syndrome)
- Central sub-epithelial or stromal scarring that could impact post-operative clarity assessment
- Peripheral anterior synechiae in the angle greater than 3 clock hours
- Hypotony
- Uncontrolled glaucoma
- Visually significant optic nerve or macular pathology
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Humberto Martinez, COT, 503-494-7712, martinhu@ohsu.edu
Denzil Romfh, OD, 503-494-4351, romfhd@ohsu.edu
About this study
Official title: Evaluating Corneal Edema in Fuchs' Endothelial Dystrophy Using Optical Coherence Tomography
This is an observational study using optical coherence tomography (OCT) technology to quantify corneal edema in Fuchs' endothelial dystrophy and predict refractive shift from resolving corneal edema after surgical treatments.
- Conditions
- Fuchs Dystrophy, Pseudophakic Bullous Keratopathy
- Keywords
- Fuchs, Pseudophakic Bullous Keratopathy, Optical Coherence Tomography (OCT), PBK
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Group A: No Surgery Group | This group consists of adults ages 18 or older who have been diagnosed with Fuchs' dystrophy or pseudophakic bullous keratopathy but do not require surgery per standard-of-care guidelines. | |
| Group B: Surgery Group | This group consists of adults ages 18 or older who have been diagnosed with Fuchs' dystrophy or pseudophakic bullous keratopathy, who require Descemet's Stripping Endothelial Keratoplasty (DSAEK), Descemet's Membrane Endothelial Keratoplasty (DMEK), or Descemet's Stripping Only (DSO) surgery. All treatment decisions will be made by the attending physician based on standard-of-care guidelines. (The study does not designate a treatment modality or pay for the treatment.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Epithelial Edema/Haze
OCT will be used to measure corneal epithelial edema/haze (in microns) in participants with Fuchs' or PBK
Measured: up to 2 years
Corneal Stromal Edema/Haze
OCT will be used to measure corneal stromal edema/haze (in microns) in participants with Fuchs' or PBK
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start26 Jun 2020
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fuchs DystrophyStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, David Huang, Oregon Health and Science University
- Investigators
- Winston Chamberlain, MD, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258787
- Sponsor's protocol ID
- OHSU IRB#00020108
- Other IDs
- R01EY029023-01
- Status last verified
- Sep 2025
- First submitted
- 4 Feb 2020
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Corneal Edema in Fuchs' Endothelial Dystrophy Using Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT04258787
- Acronym / sponsor ID
- OHSU IRB#00020108
- Conditions
- Fuchs Dystrophy, Pseudophakic Bullous Keratopathy
- Keywords
- Fuchs, Pseudophakic Bullous Keratopathy, Optical Coherence Tomography (OCT), PBK
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 26 Jun 2020 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 6 Feb 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 is an observational study using optical coherence tomography (OCT) technology to quantify corneal edema in Fuchs' endothelial dystrophy and predict refractive shift from resolving corneal edema after surgical treatments.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: No Surgery Group | – | –This group consists of adults ages 18 or older who have been diagnosed with Fuchs' dystrophy or pseudophakic bullous keratopathy but do not require surgery per standard-of-care guidelines. |
| Group B: Surgery Group | – | –This group consists of adults ages 18 or older who have been diagnosed with Fuchs' dystrophy or pseudophakic bullous keratopathy, who require Descemet's Stripping Endothelial Keratoplasty (DSAEK), Descemet's Membrane Endothelial Keratoplasty (DMEK), or Descemet's Stripping Only (DSO) surgery. All treatment decisions will be made by the attending physician based on standard-of-care guidelines. (The study does not designate a treatment modality or pay for the treatment.) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults age 18 or older with Fuchs' or PBK
Key inclusion criteria (2 listed)
- Damaged or diseased corneal endothelium from Fuchs' or PBK
- Willingness to commit to required study visits
Key exclusion criteria (8 listed)
- Prior Endothelial Keratoplasty (EK) or any other surgery except uncomplicated cataract surgery
- Presence of a condition that increases the probability for treatment failure (e.g., heavily vascularized cornea, uncontrolled uveitis)
- Other primary endothelial dysfunction conditions (e.g., posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy, iridocorneal endothelial syndrome)
- Central sub-epithelial or stromal scarring that could impact post-operative clarity assessment
- Peripheral anterior synechiae in the angle greater than 3 clock hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Corneal Epithelial Edema/Haze
Time frame: up to 2 years
OCT will be used to measure corneal epithelial edema/haze (in microns) in participants with Fuchs' or PBK
Corneal Stromal Edema/Haze
Time frame: up to 2 years
OCT will be used to measure corneal stromal edema/haze (in microns) in participants with Fuchs' or PBK
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Fuchs Dystrophy
RecruitingPhase 2
Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
Corneal Edema, Fuchs
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
Keratoconus, Ectasia
RecruitingPhase 2
DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal Dystrophy, Fuchs
Active, not recruiting
The Belgian Endothelial Surgical Transplant of the Cornea
Corneal Edema, Corneal Endothelial Disorder
Enrolling by invitationObservational study
The Effect of Topical Rho-kinase Inhibitors on Corneas of Patients With Fuchs Endothelial Corneal Dystrophy
Fuchs Endothelial Corneal Dystrophy, Cataract
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.
Winston Chamberlain, MD, PhD principal investigator
Oregon Health and Science University
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 and Pseudophakic Bullous Keratopathy, run by Oregon Health and Science University 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 2 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 9 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Humberto Martinez, COT (503-494-7712, martinhu@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal Epithelial Edema/Haze (time frame: up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2025.