Fuchs' Endothelial Corneal DystrophyPhase 1/2NCT04175938
Assessment of Corneal Endothelial Function Following Hypoxic Stress
A Phase 1/2 study testing Wearing of contact lens in people with Fuchs' Endothelial Corneal Dystrophy, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial summary
The purpose of this study is to determine the difference in the cornea's response to contact lens placement between healthy and unhealthy eyes. The amount of corneal swelling (corneal thickness) between normal and FECD patients before and after a stress test will be measured and compared. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fuchs' Endothelial Corneal Dystrophy
- What is being tested?
- Wearing of contact lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2025to 30 Nov 2027
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects in the Fuch's Dystrophy arm of the study must meet following criteria:
- Have a clinical diagnosis of Fuchs endothelial corneal dystrophy
- Be scheduled for corneal transplantation in the next 6 months
- Have no history of prior ocular surgery in study eye
- Have no history of contact lens intolerance
- Be motivated and willing to complete ocular imaging tests
Show all 11Show fewer
- Subjects in the healthy eyes arm of the study must meet following criteria:
- Have no prior history of ocular disease including ocular surface disease or glaucoma
- Have no history of prior ocular surgery in study eye
- Have no history of contact lens intolerance
- Be motivated and willing to complete ocular imaging tests
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
About this study
The purpose of this study is to determine the difference in the cornea's response to contact lens placement between healthy and unhealthy eyes. The amount of corneal swelling (corneal thickness) between normal and FECD patients before and after a stress test will be measured and compared.
Read the detailed description
Clarity of the cornea is essential for optimal vision. The endothelium is a layer within the cornea that controls its clarity. Fuchs endothelial corneal dystrophy (FECD) is a progressive disease that affects both eyes in which the endothelium is dysfunctional, causing the cornea to swell and lose its clarity. Because of the vision loss associated with this swelling, corneal transplantation is needed for patients with advanced FECD.
Currently, there is no method to directly measure how well endothelium cells are functioning in patients with FECD. Such a measurement, if it were possible, would allow physicians to identify patients who are at a higher risk of corneal swelling. The goal of this study is to establish a tool to measure and compare the amounts of corneal swelling between normal and FECD patients after a stress test is performed (the wearing of an FDA-approved contact lens.) Data will also be collected regarding how quickly and how well a cornea recovers from swelling in patients with healthy eyes compared to those with FECD.
- Conditions
- Fuchs' Endothelial Corneal Dystrophy
- Being tested
- Wearing of contact lens
- Keywords
- Fuch's Dystrophy, FECD, Fuch's Endothelial Corneal Dystrophy
- 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.
Wearing of contact lensDevice
All subjects will wear a contact lens for three hours. The effect of the lens on the eye (epithelial swelling) will be measured at intervals after the lens is removed.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Fuch's Endothelial Dystrophy | Active comparator | Persons with a diagnosis of Fuch's Endothelial Dystrophy will wear a contact lens in an affected eye for three hours. Receives: Device: Wearing of contact lens |
| Subjects with healthy eyes | Other | Persons with healthy eyes will wear a contact lens in one eye for three hours. Receives: Device: Wearing of contact lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thickness of the cornea before and after the stress test
Maximum changes in the thickness of the cornea measured before and after the stress test
Measured: seven hours
The rate of corneal recovery after the stress test
The extent of swelling evident at regular intervals during the 3 hours after the stress test
Measured: three hours
Time to full recovery from swelling
The time it takes for the eye to no longer be swollen
Measured: three hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study startDec 2025 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2027 (estimated)
Why it stopped: Awaiting transfer of study oversight from MEEI to Partners Healthcare
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fuchs' Endothelial Corneal 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A stress test will be performed (the wearing of a contact lens) to induce swelling in two groups: group A where the subjects have a diagnosis of Fuch's Endothelial Corneal Dystrophy, and group B where subjects have healthy eyes. Once the contact lens is removed, the cornea swelling will be measured in each group. The length of time it takes for the cornea to recover after being swollen will also be compared between the two groups.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ula Jurkunas, Massachusetts Eye and Ear Infirmary
- Investigators
- Ula Jurkunas, MD, Principal investigator, Massachusetts Eye and Ear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175938
- Sponsor's protocol ID
- 2019P002073
- Status last verified
- Sep 2025
- First submitted
- 18 Nov 2019
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Corneal Endothelial Function Following Hypoxic Stress
- ClinicalTrials.gov ID
- NCT04175938
- Acronym / sponsor ID
- 2019P002073
- Conditions
- Fuchs' Endothelial Corneal Dystrophy
- Keywords
- Fuch's Dystrophy, FECD, Fuch's Endothelial Corneal Dystrophy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Awaiting transfer of study oversight from MEEI to Partners Healthcare
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 25 Nov 2019 (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.
The purpose of this study is to determine the difference in the cornea's response to contact lens placement between healthy and unhealthy eyes. The amount of corneal swelling (corneal thickness) between normal and FECD patients before and after a stress test will be measured and compared.
Detailed description
Clarity of the cornea is essential for optimal vision. The endothelium is a layer within the cornea that controls its clarity. Fuchs endothelial corneal dystrophy (FECD) is a progressive disease that affects both eyes in which the endothelium is dysfunctional, causing the cornea to swell and lose its clarity. Because of the vision loss associated with this swelling, corneal transplantation is needed for patients with advanced FECD.
Currently, there is no method to directly measure how well endothelium cells are functioning in patients with FECD. Such a measurement, if it were possible, would allow physicians to identify patients who are at a higher risk of corneal swelling. The goal of this study is to establish a tool to measure and compare the amounts of corneal swelling between normal and FECD patients after a stress test is performed (the wearing of an FDA-approved contact lens.) Data will also be collected regarding how quickly and how well a cornea recovers from swelling in patients with healthy eyes compared to those with FECD.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A stress test will be performed (the wearing of a contact lens) to induce swelling in two groups: group A where the subjects have a diagnosis of Fuch's Endothelial Corneal Dystrophy, and group B where subjects have healthy eyes. Once the contact lens is removed, the cornea swelling will be measured in each group. The length of time it takes for the cornea to recover after being swollen will also be compared between the two groups.
| Arm | Type | Receives |
|---|---|---|
| Subjects with Fuch's Endothelial Dystrophy | Active comparator | Device: Wearing of contact lensPersons with a diagnosis of Fuch's Endothelial Dystrophy will wear a contact lens in an affected eye for three hours. |
| Subjects with healthy eyes | Other | Device: Wearing of contact lensPersons with healthy eyes will wear a contact lens in one eye for three hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Have a clinical diagnosis of Fuchs endothelial corneal dystrophy
- Be scheduled for corneal transplantation in the next 6 months
- Have no history of prior ocular surgery in study eye
- Have no history of contact lens intolerance
- Be motivated and willing to complete ocular imaging tests
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Wearing of contact lensAll subjects will wear a contact lens for three hours. The effect of the lens on the eye (epithelial swelling) will be measured at intervals after the lens is removed. | Device | Subjects with Fuch's Endothelial Dystrophy, Subjects with healthy eyes |
Primary outcome
Thickness of the cornea before and after the stress test
Time frame: seven hours
Maximum changes in the thickness of the cornea measured before and after the stress test
The rate of corneal recovery after the stress test
Time frame: three hours
The extent of swelling evident at regular intervals during the 3 hours after the stress test
Time to full recovery from swelling
Time frame: three hours
The time it takes for the eye to no longer be swollen
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
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A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
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The Belgian Endothelial Surgical Transplant of the Cornea
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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.
Ula Jurkunas, MD principal investigator
Massachusetts Eye and Ear
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Wearing of contact lens in people with Fuchs' Endothelial Corneal Dystrophy, run by Massachusetts Eye and Ear Infirmary 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 11 inclusion and 1 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: withdrawn, as of the sponsor's last update on 2 Mar 2026. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Thickness of the cornea before and after the stress test (time frame: seven hours). The study lists 3 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 2 Mar 2026.