Fuchs' Endothelial DystrophyNCT02542644
Assessment of Corneal Graft Attachment in Patients With Fuchs Endothelial Corneal Dystrophy Following DMEK Using Ultra-high Resolution OCT
A study testing Ultrahigh resolution Spectral Domain OCT in people with Fuchs' Endothelial Dystrophy, run by Medical University of Vienna at 2 sites in Austria.
Trial summary
Fuchs endothelial corneal dystrophy (FECD) is a progressive disease characterized by the loss of endothelial cells, thickening of Descemet's membrane and deposition of extracellular matrix in the form of guttae. This result in failure of the endothelium to support corneal deturgescence leading to corneal edema. Read more about this study
- Who is it for?
- Ages 18 to 98 years
- Conditions the study is for
- Fuchs' Endothelial Dystrophy
- What is being tested?
- Ultrahigh resolution Spectral Domain OCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesAustria
- Study dates
- 15 Nov 2017to 15 Mar 2022
- 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 to 98 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged over 18 years scheduled for primary DMEK because of Fuchs' Endothelial Dystrophy
Who cannot join
- Any disease inhibiting OCT acquisition; such as blepharospasm, severe tremor or immobility
- Any previous intraocular surgery other than cataract extraction
- Previous clinically significant ocular trauma in the study eye, as judged by the investigator
- Pregnancy, planed pregnancy, or lactating
- Appointment of a custodian
- Progressive retinal disease
- History or presence of glaucoma
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Medical University Vienna, Department of Clinical Pharmacology
Vienna, 1090
Vienna Institute for Research in Ocular Surgery (VIROS)
Vienna, 1140
About this study
Official title: Assessment of Corneal Graft Attachment in Patients With Fuchs Endothelial Corneal Dystrophy Following Descemet's Membrane Endothelial Keratoplasty Using Ultra-high Resolution Optical Coherence Tomography
Fuchs endothelial corneal dystrophy (FECD) is a progressive disease characterized by the loss of endothelial cells, thickening of Descemet's membrane and deposition of extracellular matrix in the form of guttae. This result in failure of the endothelium to support corneal deturgescence leading to corneal edema. Affected patients complain about blurred vision at early stages of the disease which can progress to blindness. The pathophysiology of the disease is still unclear, but several studies point towards a genetic susceptibility. Additional risk factors that have been identified are female sex, smoking and older age.
While for a long time penetrating keratoplasty (PKP) was the only therapy available for affected patients, in the recent years less invasive methods such as descemet's membrane endothelial keratoplasty (DMEK) have been developed. In DMEK, only the Descemet's membrane and the endothelium is removed and replaced with the corresponding parts from a donor's cornea. For FECD, this brings the advantage that only the diseased part of the cornea is replaced. Graft detachment has been identified as the main complication following DMEK.
In the investigators' study, an ultra high resolution OCT system will be used to detect graft detachment in patients with FECD after DMEK. With this technique, even small detachments can be visualized. The area of graft detachment will be evaluated at predefined time points after surgery and correlated to visual acuity. A follow-up of one year will be performed in order to investigate the predictive value of graft adherence status at several time points for visual outcome.
- Conditions
- Fuchs' Endothelial Dystrophy
- Being tested
- Ultrahigh resolution Spectral Domain OCT
- Keywords
- Fuchs' Endothelial Dystrophy, DMEK
- 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.
Ultrahigh resolution Spectral Domain OCTDevice
The area of graft detachment will be measured by a customized ultra high-resolution OCT for the cornea.
A spectrometer based ultrahigh resolution Spectral Domain OCT (SDOCT) system operating at 800 nm for the anterior chamber will be employed in the present study. The spectrum of the Ti:Sapphire laser light source is centered at 800 nm. With a full width at half maximum bandwidth of 170 nm, the axial resolution is 1.3 μm in the cornea. The transverse resolution of the employed OCT system is 21 μm at the front surface of the cornea. For measurement, patients will place their head in a modified slit lamp head rest. During the measurement period, patients will be asked to look straight forward onto an internal fixation target and to avoid blinking. Different scattering patterns, e.g. raster, circular and spiral scans will be employed.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Fuchs endothelial dystrophy scheduled for DMEK | Other | Not described Receives: Device: Ultrahigh resolution Spectral Domain OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in best corrected visual acuity at 12 months compared to baseline using a standardized protocol with the Early Treatment Diabetic Retinopathy (ETDRS) charts (4 meters).
Visual acuity will be measured using a standardized protocol with the Early Treatment Diabetic Retinopathy (ETDRS) charts (4 meters).
Measured: 1-2 days, 1 week, 1 month, 6 months and 12 months after DMEK
Area of attached graft after DMEK
Measured: 12 months after DMEK
Secondary outcomes (9)
Number of patients in which rebubbling has to be performed
Measured: 12 months
Number of patients needing retreatment
Measured: 12 months
Best corrected visual acuity at 6 months using a standardized protocol with the Early Treatment Diabetic Retinopathy (ETDRS) charts (4 meters).
Visual acuity will be measured using a standardized protocol with the Early Treatment Diabetic Retinopathy (ETDRS) charts (4 meters).
Measured: 6 months
Central corneal thickness
Measured: 12 months
Corneal endothelial cell count
Measured: 12 months
Demographic risk factors such as age
Measured: 12 months
Demographic risk factors such as gender
Measured: 12 months
Demographic risk factors, such as family history
Measured: 12 months
Demographic risk factors, such as smoking status
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2015 (estimated)
- Study start15 Nov 2017
- Primary completion15 Mar 2022
- Study completion15 Mar 2022
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.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Garhofer, Medical University of Vienna
- Investigators
- Katarzyna Witkowska, MD, Principal investigator, Department of Clinical Pharmacology, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542644
- Sponsor's protocol ID
- OPHT-013015
- Status last verified
- Apr 2022
- First submitted
- 31 Aug 2015
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Corneal Graft Attachment in Patients With Fuchs Endothelial Corneal Dystrophy Following Descemet's Membrane Endothelial Keratoplasty Using Ultra-high Resolution Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT02542644
- Acronym / sponsor ID
- OPHT-013015
- Conditions
- Fuchs' Endothelial Dystrophy
- Keywords
- Fuchs' Endothelial Dystrophy, DMEK
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 15 Mar 2022 (actual)
- First posted
- 7 Sep 2015 (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.
Fuchs endothelial corneal dystrophy (FECD) is a progressive disease characterized by the loss of endothelial cells, thickening of Descemet's membrane and deposition of extracellular matrix in the form of guttae. This result in failure of the endothelium to support corneal deturgescence leading to corneal edema. Affected patients complain about blurred vision at early stages of the disease which can progress to blindness. The pathophysiology of the disease is still unclear, but several studies point towards a genetic susceptibility. Additional risk factors that have been identified are female sex, smoking and older age.
While for a long time penetrating keratoplasty (PKP) was the only therapy available for affected patients, in the recent years less invasive methods such as descemet's membrane endothelial keratoplasty (DMEK) have been developed. In DMEK, only the Descemet's membrane and the endothelium is removed and replaced with the corresponding parts from a donor's cornea. For FECD, this brings the advantage that only the diseased part of the cornea is replaced. Graft detachment has been identified as the main complication following DMEK.
In the investigators' study, an ultra high resolution OCT system will be used to detect graft detachment in patients with FECD after DMEK. With this technique, even small detachments can be visualized. The area of graft detachment will be evaluated at predefined time points after surgery and correlated to visual acuity. A follow-up of one year will be performed in order to investigate the predictive value of graft adherence status at several time points for visual outcome.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Fuchs endothelial dystrophy scheduled for DMEK | Other | Device: Ultrahigh resolution Spectral Domain OCT |
Who may qualify
- Ages
- 18 to 98 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women aged over 18 years scheduled for primary DMEK because of Fuchs' Endothelial Dystrophy
Key exclusion criteria (7 listed)
- Any disease inhibiting OCT acquisition; such as blepharospasm, severe tremor or immobility
- Any previous intraocular surgery other than cataract extraction
- Previous clinically significant ocular trauma in the study eye, as judged by the investigator
- Pregnancy, planed pregnancy, or lactating
- Appointment of a custodian
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 |
|---|---|---|
| Ultrahigh resolution Spectral Domain OCTThe area of graft detachment will be measured by a customized ultra high-resolution OCT for the cornea. A spectrometer based ultrahigh resolution Spectral Domain OCT (SDOCT) system operating at 800 nm for the anterior chamber will be employed in the present study. The spectrum of the Ti:Sapphire laser light source is centered at 800 nm. With a full width at half maximum bandwidth of 170 nm, the axial resolution is 1.3 μm in the cornea. The transverse resolution of the employed OCT system is 21 μm at the front surface of the cornea. For measurement, patients will place their head in a modified slit lamp head rest. During the measurement period, patients will be asked to look straight forward onto an internal fixation target and to avoid blinking. Different scattering patterns, e.g. raster, circular and spiral scans will be employed. | Device | Patients with Fuchs endothelial dystrophy scheduled for DMEK |
Primary outcome
Change in best corrected visual acuity at 12 months compared to baseline using a standardized protocol with the Early Treatment Diabetic Retinopathy (ETDRS) charts (4 meters).
Time frame: 1-2 days, 1 week, 1 month, 6 months and 12 months after DMEK
Visual acuity will be measured using a standardized protocol with the Early Treatment Diabetic Retinopathy (ETDRS) charts (4 meters).
Area of attached graft after DMEK
Time frame: 12 months after DMEK
9 secondary outcomes
Number of patients in which rebubbling has to be performed
Time frame: 12 months
Number of patients needing retreatment
Time frame: 12 months
Best corrected visual acuity at 6 months using a standardized protocol with the Early Treatment Diabetic Retinopathy (ETDRS) charts (4 meters).
Time frame: 6 months
Central corneal thickness
Time frame: 12 months
Corneal endothelial cell count
Time frame: 12 months
Demographic risk factors such as age
Time frame: 12 months
Demographic risk factors such as gender
Time frame: 12 months
Demographic risk factors, such as family history
Time frame: 12 months
Demographic risk factors, such as smoking status
Time frame: 12 months
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 7 Apr 2022.
Related trials for Fuchs' Endothelial Dystrophy
Active, not recruitingPhase 3
Descemet Endothelial Thickness Comparison Trial II
Fuchs, 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
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.
Katarzyna Witkowska, MD principal investigator
Department of Clinical Pharmacology, Medical University of Vienna
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrahigh resolution Spectral Domain OCT in people with Fuchs' Endothelial Dystrophy, run by Medical University of Vienna at 2 sites in Austria.
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 7 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: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. 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?
Change in best corrected visual acuity at 12 months compared to baseline using a standardized protocol with the Early Treatment Diabetic Retinopathy (ETDRS) charts (4 meters). (time frame: 1-2 days, 1 week, 1 month, 6 months and 12 months after DMEK). 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 7 Apr 2022.