Fuchs' Endothelial Corneal DystrophyNCT02020044
Outcome After Descemet Membrane Endothelial Keratoplasty (DMEK) and Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
A study testing Endothelial Keratoplasty in people with Fuchs' Endothelial Corneal Dystrophy and Bullous Keratopathy, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The purpose of this study is evaluate the outcome after posterior lamellar keratoplasty (DMEK and Ultra-thin DSAEK) for corneal transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fuchs' Endothelial Corneal Dystrophy, Bullous Keratopathy, Iridocorneal Endothelial Syndrome
- What is being tested?
- Endothelial Keratoplasty
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2012to Dec 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
Who may be able to join
- Male or female aged 18 or older
- Scheduled to undergo endothelial keratoplasty
- Able to provide written informed consent.
Who cannot join
- Age less than 18 years
Trial locations and contacts
1 site in 1 country.
Anna-Karina Maier, MD contact
Germany1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 13353
Anna-Karina Maier, MD, +4930450654419, anna-karina.maier@charite.de
Anna-Karina Maier, MD
About this study
Official title: Prospective Clinical Study on Postoperative Outcome After Descemet Membrane Endothelial Keratoplasty (DMEK) and Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
The purpose of this study is evaluate the outcome after posterior lamellar keratoplasty (DMEK and Ultra-thin DSAEK) for corneal transplantation.
- Conditions
- Fuchs' Endothelial Corneal Dystrophy, Bullous Keratopathy, Iridocorneal Endothelial Syndrome, Posterior Polymorphous Dystrophy, Endothelial Dysfunction
- Being tested
- Endothelial Keratoplasty
- Medical subject headings
- Fuchs' Endothelial Dystrophy, Iridocorneal Endothelial Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endothelial KeratoplastyOther
Also called DMEK, Descemet Membrane Endothelial Keratoplasty, Ultra-thin Descemet stripping automated endothelial keratoplasty, Ultra-thin DSAEK
| Study group | Role | What they receive |
|---|---|---|
| Endothelial Keratoplasty | Other | Descemet membrane endothelial keratoplasty DMEK Ultra-thin Descemet stripping automated endothelial keratoplasty Ultra-thin DSAEK Receives: Other: Endothelial Keratoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity (change from baseline)
Measured: 1, 3, 6, and 12 months and annually
Secondary outcomes (9)
Endothelial cell density (change from baseline)
Measured: 1, 3, 6, and 12 months and annually
Intraocular pressure (change from baseline)
Measured: 1, 3, 6, and 12 months and annually
Manifest refraction (change from baseline)
Measured: 1, 3, 6, 12 months and annually
corneal pachymetry (change from baseline)
Measured: 1, 3, 6, 12 months and annually
Quality of Life, NEI-VFQ 25 (change from baseline)
Questionnaire
Measured: 3, 12 months, annualy
corneal topography (change from baseline)
Measured: 1, 3, 6, and 12 months and annually
Anterior Segment OCT of cornea and anterior chamber angle (change from baseline)
Measured: 1, 3, 6, and 12 months and annually
postoperative Medication (change from baseline)
Measured: 1,3,6 and 12 months and annually
Histological Sample of Recipient's Descemet Membrane
Recipient's Descemet Membrane
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startSep 2012
- Primary completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Fuchs' Endothelial Corneal DystrophyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Necip Torun, Charite University, Berlin, Germany
- Investigators
- Necip Torun, MD, Study director, Department of Ophthalmology, Charité - Unviersitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02020044
- Sponsor's protocol ID
- EA2/108/12
- Status last verified
- Dec 2013
- First submitted
- 11 Dec 2013
- Last updated
- 24 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Maier AK, Gundlach E, Gonnermann J, Klamann MK, Eulufi C, Bertelmann E, Joussen AM, Torun N. Fellow Eye Comparison of Descemet Membrane Endothelial Keratoplasty and Penetrating Keratoplasty. Cornea. 2013 Oct;32(10):1344-8. doi: 10.1097/ICO.0b013e31829dd816.
PubMed 23928950Maier AK, Gundlach E, Klamann MK, Gonnermann J, Bertelmann E, Joussen AM, Torun N, Rieck PW. [Influence of donor lamella thickness on visual acuity after Descemet's stripping automated endothelial keratoplasty (DSAEK)]. Ophthalmologe. 2014 Feb;111(2):128-34. doi: 10.1007/s00347-013-2795-0. German.
PubMed 23575642Maier AK, Klamann MK, Torun N, Gonnermann J, Schroeter J, Joussen AM, Rieck P. Intraocular pressure elevation and post-DSEK glaucoma after Descemet;s stripping endothelial keratoplasty. Graefes Arch Clin Exp Ophthalmol. 2013 Apr;251(4):1191-8. doi: 10.1007/s00417-012-2203-5. Epub 2012 Nov 20.
PubMed 23180233Guerra FP, Anshu A, Price MO, Giebel AW, Price FW. Descemet's membrane endothelial keratoplasty: prospective study of 1-year visual outcomes, graft survival, and endothelial cell loss. Ophthalmology. 2011 Dec;118(12):2368-73. doi: 10.1016/j.ophtha.2011.06.002. Epub 2011 Aug 27.
PubMed 21872938van Dijk K, Ham L, Tse WH, Liarakos VS, Quilendrino R, Yeh RY, Melles GR. Near complete visual recovery and refractive stability in modern corneal transplantation: Descemet membrane endothelial keratoplasty (DMEK). Cont Lens Anterior Eye. 2013 Feb;36(1):13-21. doi: 10.1016/j.clae.2012.10.066. Epub 2012 Oct 26.
PubMed 23108011Gundlach E, Pilger D, Brockmann T, Dietrich-Ntoukas T, Joussen AM, Torun N, Maier AB. Recovery of Contrast Sensitivity After Descemet Membrane Endothelial Keratoplasty. Cornea. 2021 Sep 1;40(9):1110-1116. doi: 10.1097/ICO.0000000000002686.
PubMed 33591041Gundlach E, Spiller N, Pilger D, Dietrich-Ntoukas T, Joussen AM, Torun N, Maier AB. Impact of difficult unfolding and attachment of the graft lamella on the long-term outcome after Descemet membrane endothelial keratoplasty. Graefes Arch Clin Exp Ophthalmol. 2020 Nov;258(11):2459-2465. doi: 10.1007/s00417-020-04852-z. Epub 2020 Jul 23.
PubMed 32705337Maier AK, Gundlach E, Pilger D, Rubsam A, Klamann MK, Gonnermann J, Bertelmann E, Joussen AM, Torun N. Rate and Localization of Graft Detachment in Descemet Membrane Endothelial Keratoplasty. Cornea. 2016 Mar;35(3):308-12. doi: 10.1097/ICO.0000000000000740.
PubMed 26764881Gonnermann J, Maier AK, Klamann MK, Brockmann T, Bertelmann E, Joussen AM, Torun N. Posterior iris-claw aphakic intraocular lens implantation and Descemet membrane endothelial keratoplasty. Br J Ophthalmol. 2014 Sep;98(9):1291-5. doi: 10.1136/bjophthalmol-2014-304948. Epub 2014 Apr 29.
PubMed 24782475
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study on Postoperative Outcome After Descemet Membrane Endothelial Keratoplasty (DMEK) and Ultra-thin Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)
- ClinicalTrials.gov ID
- NCT02020044
- Acronym / sponsor ID
- EA2/108/12
- Conditions
- Fuchs' Endothelial Corneal Dystrophy, Bullous Keratopathy, Iridocorneal Endothelial Syndrome, Posterior Polymorphous Dystrophy, Endothelial Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2015 (estimated)
- First posted
- 24 Dec 2013 (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 purpose of this study is evaluate the outcome after posterior lamellar keratoplasty (DMEK and Ultra-thin DSAEK) for corneal transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endothelial Keratoplasty | Other | Other: Endothelial KeratoplastyDescemet membrane endothelial keratoplasty DMEK Ultra-thin Descemet stripping automated endothelial keratoplasty Ultra-thin DSAEK |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female aged 18 or older
- Scheduled to undergo endothelial keratoplasty
- Able to provide written informed consent.
Key exclusion criteria (1 listed)
- Age less than 18 years
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 |
|---|---|---|
| Endothelial KeratoplastyAlso: DMEK, Descemet Membrane Endothelial Keratoplasty, Ultra-thin Descemet stripping automated endothelial keratoplasty, Ultra-thin DSAEK | Other | Endothelial Keratoplasty |
Primary outcome
Visual acuity (change from baseline)
Time frame: 1, 3, 6, and 12 months and annually
9 secondary outcomes
Endothelial cell density (change from baseline)
Time frame: 1, 3, 6, and 12 months and annually
Intraocular pressure (change from baseline)
Time frame: 1, 3, 6, and 12 months and annually
Manifest refraction (change from baseline)
Time frame: 1, 3, 6, 12 months and annually
corneal pachymetry (change from baseline)
Time frame: 1, 3, 6, 12 months and annually
Quality of Life, NEI-VFQ 25 (change from baseline)
Time frame: 3, 12 months, annualy
corneal topography (change from baseline)
Time frame: 1, 3, 6, and 12 months and annually
Anterior Segment OCT of cornea and anterior chamber angle (change from baseline)
Time frame: 1, 3, 6, and 12 months and annually
postoperative Medication (change from baseline)
Time frame: 1,3,6 and 12 months and annually
Histological Sample of Recipient's Descemet Membrane
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
- Background: PubMed 23928950Maier AK, Gundlach E, Gonnermann J, Klamann MK, Eulufi C, Bertelmann E, Joussen AM, Torun N. Fellow Eye Comparison of Descemet Membrane Endothelial Keratoplasty and Penetrating Keratoplasty. Cornea. 2013 Oct;32(10):1344-8. doi: 10.1097/ICO.0b013e31829dd816.
- Background: PubMed 23575642Maier AK, Gundlach E, Klamann MK, Gonnermann J, Bertelmann E, Joussen AM, Torun N, Rieck PW. [Influence of donor lamella thickness on visual acuity after Descemet's stripping automated endothelial keratoplasty (DSAEK)]. Ophthalmologe. 2014 Feb;111(2):128-34. doi: 10.1007/s00347-013-2795-0. German.
- Background: PubMed 23180233Maier AK, Klamann MK, Torun N, Gonnermann J, Schroeter J, Joussen AM, Rieck P. Intraocular pressure elevation and post-DSEK glaucoma after Descemet;s stripping endothelial keratoplasty. Graefes Arch Clin Exp Ophthalmol. 2013 Apr;251(4):1191-8. doi: 10.1007/s00417-012-2203-5. Epub 2012 Nov 20.
- Background: PubMed 21872938Guerra FP, Anshu A, Price MO, Giebel AW, Price FW. Descemet's membrane endothelial keratoplasty: prospective study of 1-year visual outcomes, graft survival, and endothelial cell loss. Ophthalmology. 2011 Dec;118(12):2368-73. doi: 10.1016/j.ophtha.2011.06.002. Epub 2011 Aug 27.
- Background: PubMed 23108011van Dijk K, Ham L, Tse WH, Liarakos VS, Quilendrino R, Yeh RY, Melles GR. Near complete visual recovery and refractive stability in modern corneal transplantation: Descemet membrane endothelial keratoplasty (DMEK). Cont Lens Anterior Eye. 2013 Feb;36(1):13-21. doi: 10.1016/j.clae.2012.10.066. Epub 2012 Oct 26.
- Derived from this study: PubMed 33591041Gundlach E, Pilger D, Brockmann T, Dietrich-Ntoukas T, Joussen AM, Torun N, Maier AB. Recovery of Contrast Sensitivity After Descemet Membrane Endothelial Keratoplasty. Cornea. 2021 Sep 1;40(9):1110-1116. doi: 10.1097/ICO.0000000000002686.
- Derived from this study: PubMed 32705337Gundlach E, Spiller N, Pilger D, Dietrich-Ntoukas T, Joussen AM, Torun N, Maier AB. Impact of difficult unfolding and attachment of the graft lamella on the long-term outcome after Descemet membrane endothelial keratoplasty. Graefes Arch Clin Exp Ophthalmol. 2020 Nov;258(11):2459-2465. doi: 10.1007/s00417-020-04852-z. Epub 2020 Jul 23.
- Derived from this study: PubMed 26764881Maier AK, Gundlach E, Pilger D, Rubsam A, Klamann MK, Gonnermann J, Bertelmann E, Joussen AM, Torun N. Rate and Localization of Graft Detachment in Descemet Membrane Endothelial Keratoplasty. Cornea. 2016 Mar;35(3):308-12. doi: 10.1097/ICO.0000000000000740.
- Derived from this study: PubMed 24782475Gonnermann J, Maier AK, Klamann MK, Brockmann T, Bertelmann E, Joussen AM, Torun N. Posterior iris-claw aphakic intraocular lens implantation and Descemet membrane endothelial keratoplasty. Br J Ophthalmol. 2014 Sep;98(9):1291-5. doi: 10.1136/bjophthalmol-2014-304948. Epub 2014 Apr 29.
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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.
Anna-Karina Maier, MD contact
Necip Torun, MD study director
Department of Ophthalmology, Charité - Unviersitätsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endothelial Keratoplasty in people with Fuchs' Endothelial Corneal Dystrophy and Bullous Keratopathy, run by Charite University, Berlin, Germany at 1 site in Germany.
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 3 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: status not confirmed, as of the sponsor's last update on 24 Dec 2013. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna-Karina Maier, MD (anna-karina.maier@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (change from baseline) (time frame: 1, 3, 6, and 12 months and annually). 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 NCT02020044, which also lists 9 linked publications.
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 24 Dec 2013.