Fuchs' Endothelial DystrophyNCT04420429
The Effect Of Preoperative Parameters On Success After DMEK Surgery
An observational study of Fuchs' Endothelial Dystrophy and Pseudophakic Bullous Keratopathy, run by Beyoglu Eye Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effect of preoperative parameters on surgical results in Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fuchs' Endothelial Dystrophy, Pseudophakic Bullous Keratopathy, Descemet's Membrane; Defect
- What is being tested?
- Descemet membrane endothelial keratoplasty (DMEK)
- Type of treatment
- Surgery or procedure
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 10 Jul 2022
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
Study population: Patients who developed pseudophakic bullous keratopathy, Fuchs endothelial dystrophy, endothelial insufficiency after herpetic endotheliitis and associated permanent corneal edema and therefore DMEK surgery.
Who may be able to join
- Scheduled to undergo Descemet membrane endothelial keratoplasty(DMEK)
- aged 18 old older
Who cannot join
- Patients with corneal pathology other than endothelial insufficiency
- Glaucoma patients,
- Patients who have previously had any keratoplasty procedure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Beyoğlu Eye Training and Research Hospital
Istanbul, 34420
About this study
Official title: The Effect Of Preoperative Anterior Segment Parameters On Success After Descemet Membrane Endothelial Keratoplasty (Dmek) Surgery
The aim of this study is to evaluate the effect of preoperative parameters on surgical results in Descemet Membrane Endothelial Keratoplasty (DMEK) surgery.
Read the detailed description
In patients undergoing Descemet Membrane Endothelial Keratoplasty (DMEK) surgery; preoperative anterior chamber depth, angle parameters, axial length and corneal parameters will be evaluated. The effects of these parameters on surgical results will be examined.
- Conditions
- Fuchs' Endothelial Dystrophy, Pseudophakic Bullous Keratopathy, Descemet's Membrane; Defect, Herpetic Keratitis, Angle's Classification, Endothelial Dysfunction
- Being tested
- Descemet membrane endothelial keratoplasty (DMEK)
- Keywords
- Descemet Membrane, anterior chamber depth, axial length, endothelial count, Descemet membrane endothelial keratoplasty
- Medical subject headings
- Fuchs' Endothelial Dystrophy, Keratitis, Herpetic, Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Descemet membrane endothelial keratoplasty (DMEK)Procedure or surgery
All participants underwent DMEK surgery
| Study group | Role | What they receive |
|---|---|---|
| Cohort | All patients Receives: Procedure: Descemet membrane endothelial keratoplasty (DMEK) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual acuity
Change from baseline
Measured: Baseline and after surgery 1, 3, 6, and 12 months
Change in endothelial cell density
Change from baseline
Measured: after surgery 1, 3, 6, and 12 months
Secondary outcomes (5)
Change in maximum (steepest) and minimum (flattest) keratometry values in the central corneal zone
Change from baseline
Measured: Baseline and after surgery 1, 3, 6, and 12 months
Change in anterior chamber depth
Change from baseline
Measured: Baseline and after surgery 1, 3, 6, and 12 months
Change in axial length
Change from baseline
Measured: Baseline and after surgery 1, 3, 6, and 12 months
Change in central pachymetry
Change from baseline
Measured: Baseline and after surgery 1, 3, 6, and 12 months
Change in intraocular pressure
Change from baseline
Measured: Baseline and after surgery 1, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Jun 2019
- Primary completion31 Dec 2021
- Study completion10 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Beyoglu Eye Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Semih Çakmak, Beyoglu Eye Research and Education Hospital
- Investigators
- Semih Çakmak, MD, Principal investigator, Beyoglu Eye Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420429
- Sponsor's protocol ID
- BeyogluEREH
- Status last verified
- Jul 2022
- First submitted
- 16 May 2020
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cakmak S, Kirgiz A, Yildirim Y, Taskoparan S, Genc S, Agca A. The effect of anterior segment parameters on surgical success of Descemet membrane endothelial keratoplasty: a prospective study. Int Ophthalmol. 2023 Jan;43(1):197-205. doi: 10.1007/s10792-022-02416-0. Epub 2022 Jul 10.
PubMed 35810243
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Preoperative Anterior Segment Parameters On Success After Descemet Membrane Endothelial Keratoplasty (Dmek) Surgery
- ClinicalTrials.gov ID
- NCT04420429
- Acronym / sponsor ID
- BeyogluEREH
- Conditions
- Fuchs' Endothelial Dystrophy, Pseudophakic Bullous Keratopathy, Descemet's Membrane; Defect, Herpetic Keratitis, Angle's Classification, Endothelial Dysfunction
- Keywords
- Descemet Membrane, anterior chamber depth, axial length, endothelial count, Descemet membrane endothelial keratoplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Beyoglu Eye Research and Education HospitalOther government
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 9 Jun 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.
The aim of this study is to evaluate the effect of preoperative parameters on surgical results in Descemet Membrane Endothelial Keratoplasty (DMEK) surgery.
Detailed description
In patients undergoing Descemet Membrane Endothelial Keratoplasty (DMEK) surgery; preoperative anterior chamber depth, angle parameters, axial length and corneal parameters will be evaluated. The effects of these parameters on surgical results will be examined.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | Procedure: Descemet membrane endothelial keratoplasty (DMEK)All patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who developed pseudophakic bullous keratopathy, Fuchs endothelial dystrophy, endothelial insufficiency after herpetic endotheliitis and associated permanent corneal edema and therefore DMEK surgery.
Key inclusion criteria (2 listed)
- Scheduled to undergo Descemet membrane endothelial keratoplasty(DMEK)
- aged 18 old older
Key exclusion criteria (3 listed)
- Patients with corneal pathology other than endothelial insufficiency
- Glaucoma patients,
- Patients who have previously had any keratoplasty procedure
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 |
|---|---|---|
| Descemet membrane endothelial keratoplasty (DMEK)All participants underwent DMEK surgery | Procedure or surgery | Cohort |
Primary outcome
Change in visual acuity
Time frame: Baseline and after surgery 1, 3, 6, and 12 months
Change from baseline
Change in endothelial cell density
Time frame: after surgery 1, 3, 6, and 12 months
Change from baseline
5 secondary outcomes
Change in maximum (steepest) and minimum (flattest) keratometry values in the central corneal zone
Time frame: Baseline and after surgery 1, 3, 6, and 12 months
Change in anterior chamber depth
Time frame: Baseline and after surgery 1, 3, 6, and 12 months
Change in axial length
Time frame: Baseline and after surgery 1, 3, 6, and 12 months
Change in central pachymetry
Time frame: Baseline and after surgery 1, 3, 6, and 12 months
Change in intraocular pressure
Time frame: Baseline and after surgery 1, 3, 6, and 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 20 Jul 2022.
- Derived from this study: PubMed 35810243Cakmak S, Kirgiz A, Yildirim Y, Taskoparan S, Genc S, Agca A. The effect of anterior segment parameters on surgical success of Descemet membrane endothelial keratoplasty: a prospective study. Int Ophthalmol. 2023 Jan;43(1):197-205. doi: 10.1007/s10792-022-02416-0. Epub 2022 Jul 10.
- Individual participant dataSharing planned: No
Related trials for Fuchs' Endothelial Dystrophy
Active, not recruitingPhase 3
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Study of EO2002 in Subjects With Corneal Edema Secondary to Corneal Endothelial Dysfunction
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RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
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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
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.
Semih Çakmak, MD principal investigator
Beyoglu Eye Training and Research Hospital
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' Endothelial Dystrophy and Pseudophakic Bullous Keratopathy, run by Beyoglu Eye Research and Education Hospital at 1 site in Turkey (Türkiye).
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 3 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 20 Jul 2022. 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 Turkey (Türkiye). 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 visual acuity (time frame: Baseline and after surgery 1, 3, 6, and 12 months). 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?
On the ClinicalTrials.gov record for NCT04420429, which also lists 1 linked publication.
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 20 Jul 2022; AzTrials last refreshed its copy on 7 Nov 2026.