Fuchs' Endothelial DystrophyDSAEKNCT01586234
OCT-guided DSAEK Graft Shaping and Smoothing
A study testing DSAEK with graft shaping and smoothing and Standard DSAEK in people with Fuchs' Endothelial Dystrophy, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The primary goal of this study is to determine if excimer laser smoothing of the cornea before Descemet's stripping automated endothelial keratoplasty (DSAEK)improves postoperative Best Spectacle Corrected Visual Acuity (BSCVA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fuchs' Endothelial Dystrophy
- What is being tested?
- DSAEK with graft shaping and smoothing and Standard DSAEK
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to 31 Aug 2014
- 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
Who may be able to join
- Adults with visual complaint and objective evidence of decreased vision due to corneal edema related to Fuchs' corneal endothelial dystrophy
Who cannot join
- Inability to give informed consent
- Inability to maintain stable fixation for OCT imaging
- Inability to commit to required visits to complete the study
- Eyes with concurrent cataract, retinal diseases, glaucoma, or other eye conditions that may limit the visual outcome after surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial of OCT-guided DSAEK Graft Shaping and Smoothing
The primary goal of this study is to determine if excimer laser smoothing of the cornea before Descemet's stripping automated endothelial keratoplasty (DSAEK)improves postoperative Best Spectacle Corrected Visual Acuity (BSCVA).
Read the detailed description
Many surgeons are moving away from full thickness corneal transplantation (because of risks involving rejection, irregular astigmatism, and wound dehiscence) to partial thickness transplantations of either the anterior or posterior (endothelial) layers. However this technique is not without its drawbacks. DSAEK uses a mechanical microkeratome to cut the graft, but vision is limited by the roughness of the cut surface.
DSAEK can lead to significant refractive error due to the non-uniform shape of the microkeratome cut graft, and the roughness of the microkeratome cut surface limits vision to an average of 20/31. Optical coherence tomography (OCT)-guided laser shaping and smoothing may improve the refractive and visual outcome.
- Conditions
- Fuchs' Endothelial Dystrophy
- Being tested
- DSAEK with graft shaping and smoothing, Standard DSAEK
- Keywords
- Fuchs' endothelial dystrophy, DSAEK, Descemet's stripping automated endothelial keratoplasty
- 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.
DSAEK with graft shaping and smoothingProcedure or surgery
- A 5mm incision will be made in the sclera (white portion) of the eye, approximately 1mm from the edge of the cornea
- The tissue on the underside of the cornea (endothelium) will be scraped away
- The graft from the donor cornea (previously smoothed with a laser) will be inserted through the incision and placed against the endothelium of the host cornea.
Standard DSAEKProcedure or surgery
- A 5mm incision will be made in the sclera (white portion) of the eye, approximately 1mm from the edge of the cornea
- The tissue on the underside of the cornea (endothelium) will be scraped away
- The graft from the donor cornea will be inserted through the incision and placed against the endothelium of the host cornea.
| Study group | Role | What they receive |
|---|---|---|
| DSAEK with graft shaping and smoothing | Experimental | Not described Receives: Procedure: DSAEK with graft shaping and smoothing |
| Standard DSAEK | Active comparator | Not described Receives: Procedure: Standard DSAEK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with better post-operative spectacle-corrected visual acuity when implant graft is smoothed with eximer laser versus no smoothing of the graft.
To determine whether OCT-guided excimer laser graft shaping improves postoperative visual acuity, including reduction of postoperative hyperopic shift and improvement of the predictability of postoperative refraction.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2012 (estimated)
- Study startJan 2012
- Primary completion31 Aug 2014
- Study completion31 Aug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fuchs' Endothelial 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Huang, Legacy Health System
- Investigators
- Mark Terry, MD, Principal investigator, Devers Eye Institute, Legacy Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586234
- Sponsor's protocol ID
- OHSU IRB#00006612 DSAEK
- Acronym
- DSAEK
- Status last verified
- Apr 2018
- First submitted
- 3 Jan 2012
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of OCT-guided DSAEK Graft Shaping and Smoothing
- ClinicalTrials.gov ID
- NCT01586234
- Acronym / sponsor ID
- DSAEK / OHSU IRB#00006612 DSAEK
- Conditions
- Fuchs' Endothelial Dystrophy
- Keywords
- Fuchs' endothelial dystrophy, DSAEK, Descemet's stripping automated endothelial keratoplasty
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- 31 Aug 2014 (actual)
- Study completion
- 31 Aug 2014 (actual)
- First posted
- 26 Apr 2012 (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.
The primary goal of this study is to determine if excimer laser smoothing of the cornea before Descemet's stripping automated endothelial keratoplasty (DSAEK)improves postoperative Best Spectacle Corrected Visual Acuity (BSCVA).
Detailed description
Many surgeons are moving away from full thickness corneal transplantation (because of risks involving rejection, irregular astigmatism, and wound dehiscence) to partial thickness transplantations of either the anterior or posterior (endothelial) layers. However this technique is not without its drawbacks. DSAEK uses a mechanical microkeratome to cut the graft, but vision is limited by the roughness of the cut surface.
DSAEK can lead to significant refractive error due to the non-uniform shape of the microkeratome cut graft, and the roughness of the microkeratome cut surface limits vision to an average of 20/31. Optical coherence tomography (OCT)-guided laser shaping and smoothing may improve the refractive and visual outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DSAEK with graft shaping and smoothing | Experimental | Procedure: DSAEK with graft shaping and smoothing |
| Standard DSAEK | Active comparator | Procedure: Standard DSAEK |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults with visual complaint and objective evidence of decreased vision due to corneal edema related to Fuchs' corneal endothelial dystrophy
Key exclusion criteria (4 listed)
- Inability to give informed consent
- Inability to maintain stable fixation for OCT imaging
- Inability to commit to required visits to complete the study
- Eyes with concurrent cataract, retinal diseases, glaucoma, or other eye conditions that may limit the visual outcome after surgery
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 |
|---|---|---|
| DSAEK with graft shaping and smoothing1. A 5mm incision will be made in the sclera (white portion) of the eye, approximately 1mm from the edge of the cornea 2. The tissue on the underside of the cornea (endothelium) will be scraped away 3. The graft from the donor cornea (previously smoothed with a laser) will be inserted through the incision and placed against the endothelium of the host cornea. | Procedure or surgery | DSAEK with graft shaping and smoothing |
| Standard DSAEK1. A 5mm incision will be made in the sclera (white portion) of the eye, approximately 1mm from the edge of the cornea 2. The tissue on the underside of the cornea (endothelium) will be scraped away 3. The graft from the donor cornea will be inserted through the incision and placed against the endothelium of the host cornea. | Procedure or surgery | Standard DSAEK |
Primary outcome
Number of patients with better post-operative spectacle-corrected visual acuity when implant graft is smoothed with eximer laser versus no smoothing of the graft.
Time frame: 24 months
To determine whether OCT-guided excimer laser graft shaping improves postoperative visual acuity, including reduction of postoperative hyperopic shift and improvement of the predictability of postoperative refraction.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
Related trials for Fuchs' Endothelial 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. This study is not recruiting at the moment.
Mark Terry, MD principal investigator
Devers Eye Institute, Legacy Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DSAEK with graft shaping and smoothing and Standard DSAEK in people with Fuchs' Endothelial Dystrophy, 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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 17 Apr 2018. 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 was stopped early. Results are not available in the source record.
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?
Number of patients with better post-operative spectacle-corrected visual acuity when implant graft is smoothed with eximer laser versus no smoothing of the graft. (time frame: 24 months). 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 17 Apr 2018.