Fuchs' Corneal DystrophyNCT02206594
Combined Cataract Surgery and Planned Descemetorhexis
A study testing Descemetorhexis in people with Fuchs' Corneal Dystrophy and Cataract, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
A pilot study designed to assess the feasibility of planned descemetorhexis for the treatment of Fuchs' corneal dystrophy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fuchs' Corneal Dystrophy, Cataract
- What is being tested?
- Descemetorhexis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Aug 2015
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
General Inclusion Criteria:
- Patient >18 years old
- Willing and able to provide informed consent
Ocular Inclusion Criteria (all ocular inclusion criteria apply only to the study eye):
- Fuchs' corneal dystrophy diagnosed
- Cataract present
- Best corrected visual acuity ≤ 20/40
- Candidate for current endothelial transplant procedure (DSAEK, DMEK)
General Exclusion Criteria:
- <18 years old
- Medically unstable patient
- Monocular patient
- Unwilling or unable to provide informed consent
Ocular Exclusion Criteria (all ocular exclusion criteria apply only to the study eye):
- Corneal dystrophy other than Fuchs'
- Central corneal scar or central opacity not related to Fuchs'
- Severe nonproliferative diabetic retinopathy or proliferative diabetic retinopathy
- History of prior vitreoretinal surgery
- Advanced or unstable glaucoma
- Known steroid responders with glaucoma
Trial locations and contacts
1 site in 1 country.
United States1 site
The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
A pilot study designed to assess the feasibility of planned descemetorhexis for the treatment of Fuchs' corneal dystrophy.
- Conditions
- Fuchs' Corneal Dystrophy, Cataract
- Being tested
- Descemetorhexis
- Medical subject headings
- Fuchs' Endothelial Dystrophy, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DescemetorhexisProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Descemetorhexis | Experimental | Not described Receives: Procedure: Descemetorhexis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal clarity as assessed by slit lamp photography
Measured: Assessed up to 1 year following descemetorhexis
Secondary outcomes (1)
Resolution of edema as assessed by slit lamp photography
Measured: Assessed up to 1 year following descemetorhexis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fuchs' 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steve Koenig, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206594
- Sponsor's protocol ID
- MCW-EI-001
- Status last verified
- Jul 2014
- First submitted
- 18 Apr 2014
- Last updated
- 21 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Cataract Surgery and Planned Descemetorhexis
- ClinicalTrials.gov ID
- NCT02206594
- Acronym / sponsor ID
- MCW-EI-001
- Conditions
- Fuchs' Corneal Dystrophy, Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2015 (actual)
- First posted
- 1 Aug 2014 (estimated)
- 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.
A pilot study designed to assess the feasibility of planned descemetorhexis for the treatment of Fuchs' corneal dystrophy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Descemetorhexis | Experimental | Procedure: Descemetorhexis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Descemetorhexis | Procedure or surgery | Descemetorhexis |
Primary outcome
Corneal clarity as assessed by slit lamp photography
Time frame: Assessed up to 1 year following descemetorhexis
1 secondary outcome
Resolution of edema as assessed by slit lamp photography
Time frame: Assessed up to 1 year following descemetorhexis
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 21 Aug 2015.
Related trials for Fuchs' Corneal Dystrophy
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RecruitingObservational study
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RecruitingPhase 2
DT-168 in Keratoplasty Patients With Fuchs Endothelial Corneal Dystrophy
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Active, not recruiting
The Belgian Endothelial Surgical Transplant of the Cornea
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Descemetorhexis in people with Fuchs' Corneal Dystrophy and Cataract, run by Medical College of Wisconsin 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?
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 21 Aug 2015. 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?
Corneal clarity as assessed by slit lamp photography (time frame: Assessed up to 1 year following descemetorhexis). 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 21 Aug 2015.