Patients Undergoing DMEK With a History of Anterior or Posterior Segment SurgeryDMEK complexesNCT06013462
DMEK Endothelial Keratoplasty in Patients With a History of Anterior or Posterior Segment Surgery
An observational study of Patients Undergoing DMEK With a History of Anterior or Posterior Segment Surgery, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
DMEK (Descemet Membrane Endothelial Keratoplasty) is a surgical technique used to treat primary or secondary corneal endothelial decompensation. At the Rothschild Foundation, as in many Western referral centers, DMEK is currently the surgical technique of choice for the treatment of primary or secondary corneal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Undergoing DMEK With a History of Anterior or Posterior Segment Surgery
- What is being tested?
- Descemet Membrane Endothelial Keratoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2024to Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Group of 80 patients admitted for consultation at the Hôpital Fondation Adolphe de Rothschild up to one year prior to endothelial transplantation and meeting the above eligibility criteria.
Who may be able to join
- Patients scheduled for corneal endothelial transplantation in one or both eyes
- History of vitrectomy, trabeculectomy, large iris defects, anterior synechiae on the eye to be operated on
- Pseudophakia or aphakia in the eye to be operated on
- Express consent to participate in the study
- Affiliated or beneficiary of a social security scheme
Who cannot join
- Need for combined PKE + EK surgery
- Primary endothelial decompensation
- At least one contraindication to endothelial transplantation :
- Presence of a stromal corneal cleft
- Inflammatory or degenerative corneal pathology other than endothelial
- Progressive corneal infection
Show all 11Show fewer
- Degenerative retinal pathology not allowing visual recovery postoperatively (for the purposes of this study, we accept patients who have had retinal detachment and whose loss of vision is clearly attributable to endothelial decompensation)
- End-stage glaucoma not allowing visual recovery post-operatively (for this study, we accept patients who have had filtering surgery for glaucoma, which is stabilized at the time of surgery. Decline in vision must be clearly attributable to endothelial decompensation)
- Medical contraindication to general or local anesthesia
- Patient under legal protection
- Pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Fondation Ophtalmologique A de Rothschild
Paris, 75019
Alain SAAD
asaad@for.paris
About this study
Official title: DMEK Endothelial Keratoplasty in Patients With a History of Anterior or Posterior Segment Surgery : Serious Complication Rate and Visual Efficacy at 12 Months
DMEK (Descemet Membrane Endothelial Keratoplasty) is a surgical technique used to treat primary or secondary corneal endothelial decompensation. At the Rothschild Foundation, as in many Western referral centers, DMEK is currently the surgical technique of choice for the treatment of primary or secondary corneal endothelial decompensation.
Technically challenging, it is a relatively tedious surgery to learn, but offers the best visual and refractive results, as well as faster visual and functional recovery in simple cases.
Read more
In patients without anterior or posterior segment surgical history, the complication rate of DMEK, including graft rejection, is similar to that of other endothelial keratoplasty surgical techniques.
However, in specific cases, in patients with a history of ophthalmological surgery such as vitrectomy, trabeculectomy, large iris defects, anterior synechiae, aniridia or aphakia, the scientific literature shows a higher complication rate for DMEK (increased rate of rebulling and graft decompensation).
As a result, other techniques that are less effective on visual results continue to be used for these patients in a large number of centers.
Nonetheless, in our department, DMEK is also performed on these complicated patients.
When it comes to patients with a history of anterior or posterior segment surgery, it seems to us that the surgeons' experience with DMEK allows better visual results than with any other technique, but without any back up regarding the complication rate in the literature.
The main aim of this study is to describe, in patients with a history of anterior or posterior segment surgery undergoing DMEK, the 12-months occurrence rate of at least one serious post-operative complication.
- Being tested
- Descemet Membrane Endothelial Keratoplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Descemet Membrane Endothelial KeratoplastyProcedure or surgery
DMEK (Descemet Membrane Endothelial Keratoplasty) is a surgical technique used to treat primary or secondary corneal endothelial decompensation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence rate of at least one serious DMEK post-op complication
Composite endpoint made of 4 serious post-op complications :
- Rebulling : graft detachment of more than one-third of its surface area one week after surgery (on Avanti OCT-cornea), requiring air or gas injection in the anterior chamber.
- Graft failure : no improvement in pachymetry at three months post-op (Avanti OCT-cornea).
- Graft rejection : presence of cellular Tyndall in the anterior chamber and/or retro-descemetic precipitates and/or focal or diffuse increase in pachymetry > 20μm (Avanti OCT-cornea and slit-lamp biomicroscopic examination).
- Macular cystoid edema : presence of intraretinal fluid in the macular area (macular OCT).
Measured: 12 months
Secondary outcomes (28)
Rebulling occurrence rate
Graft detachment of more than one-third of its surface area one week after surgery (on Avanti OCT-cornea), requiring air or gas injection in the anterior chamber.
Measured: 12 months
Graft failure occurrence rate
No improvement in pachymetry at three months post-op (Avanti OCT-cornea).
Measured: 12 months
Graft rejection occurrence rate
Presence of cellular Tyndall in the anterior chamber and/or retro-descemetic precipitates and/or focal or diffuse increase in pachymetry > 20μm (Avanti OCT-cornea and slit-lamp biomicroscopic examination).
Measured: 12 months
Macular cystoid edema occurrence rate
Presence of intraretinal fluid in the macular area (macular OCT).
Measured: 12 months
Intraocular hypertension occurrence rate
Intraocular pressure greater than 21mmHg measured by pneumotonometer or applanation tonometer.
Measured: 12 months
Graft detachment (with or without rebulling) occurrence rate
Failure of the graft to press against the posterior host corneal stroma (Avanti OCT-cornea and slit-lamp biomicroscopic examination).
Measured: 12 months
Surgeon's subjective assessment of surgical complexity
Evaluation by the main surgeon at the end of the procedure, on a Likert scale from 0 to 10 (0 being normal, uncomplicated surgery and 10 being the maximum level of complexity encountered).
Measured: Right after the completion of the surgery
Duration of surgical procedure (in minutes)
The start of the procedure is defined by the placement of the blepharostat and the end of the procedure is defined by the end of the lens dressing.
Measured: Right after the completion of the surgery
Evolution of visual results (corrected and uncorrected)
Measurements with optotypes :
Best monocular visual acuity (decimal scale converted to logMAR)
Measured: 1 month after surgery
Evolution of visual results (corrected and uncorrected)
Measurements with optotypes :
Best monocular visual acuity (decimal scale converted to logMAR)
Measured: 3 months after surgery
Evolution of visual results (corrected and uncorrected)
Measurements with optotypes :
Best monocular visual acuity (decimal scale converted to logMAR)
Measured: 6 months after surgery
Evolution of visual results (corrected and uncorrected)
Measurements with optotypes :
Best monocular visual acuity (decimal scale converted to logMAR)
Measured: 12 months after surgery
Evolution of refractive results
Nidek® autorefractometer measurement :
- Sphere (in dioptres)
- Cylinder (in dioptres)
- Spherical equivalent (in dioptres)
- Cylinder axis (in degrees)
Measured: 1 month after surgery
Evolution of refractive results
Nidek® autorefractometer measurement :
- Sphere (in dioptres)
- Cylinder (in dioptres)
- Spherical equivalent (in dioptres)
- Cylinder axis (in degrees)
Measured: 3 months after surgery
Evolution of refractive results
Nidek® autorefractometer measurement :
- Sphere (in dioptres)
- Cylinder (in dioptres)
- Spherical equivalent (in dioptres)
- Cylinder axis (in degrees)
Measured: 6 months after surgery
Evolution of refractive results
Nidek® autorefractometer measurement :
- Sphere (in dioptres)
- Cylinder (in dioptres)
- Spherical equivalent (in dioptres)
- Cylinder axis (in degrees)
Measured: 12 months after surgery
Evolution of endothelial loss
Measurement by central and peripheral specular microscopy (4 measurements performed nasally, temporally, superiorly and inferiorly). Endothelial loss in each quadrant is defined as a decrease in endothelial count (cells/mm²) expressed as a % relative to the pre-operative measurement.
Measured: 1 month after surgery
Evolution of endothelial loss
Measurement by central and peripheral specular microscopy (4 measurements performed nasally, temporally, superiorly and inferiorly). Endothelial loss in each quadrant is defined as a decrease in endothelial count (cells/mm²) expressed as a % relative to the pre-operative measurement.
Measured: 3 months after surgery
Evolution of endothelial loss
Measurement by central and peripheral specular microscopy (4 measurements performed nasally, temporally, superiorly and inferiorly). Endothelial loss in each quadrant is defined as a decrease in endothelial count (cells/mm²) expressed as a % relative to the pre-operative measurement.
Measured: 6 months after surgery
Evolution of endothelial loss
Measurement by central and peripheral specular microscopy (4 measurements performed nasally, temporally, superiorly and inferiorly). Endothelial loss in each quadrant is defined as a decrease in endothelial count (cells/mm²) expressed as a % relative to the pre-operative measurement.
Measured: 12 months after surgery
Evolution of corneal thickness
Corneal thickness in μm measured by OCT - Avanti® type cornea.
Measured: 1 month after surgery
Evolution of corneal thickness
Corneal thickness in μm measured by OCT - Avanti® type cornea.
Measured: 3 months after surgery
Evolution of corneal thickness
Corneal thickness in μm measured by OCT - Avanti® type cornea.
Measured: 6 months after surgery
Evolution of corneal thickness
Corneal thickness in μm measured by OCT - Avanti® type cornea.
Measured: 12 months after surgery
Evolution of posterior keratometry
Posterior keratometry in diopters measured by Scheimpflug corneal topography (Pentacam®).
Measured: 1 month after surgery
Evolution of posterior keratometry
Posterior keratometry in diopters measured by Scheimpflug corneal topography (Pentacam®).
Measured: 3 months after surgery
Evolution of posterior keratometry
Posterior keratometry in diopters measured by Scheimpflug corneal topography (Pentacam®).
Measured: 6 months after surgery
Evolution of posterior keratometry
Posterior keratometry in diopters measured by Scheimpflug corneal topography (Pentacam®).
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start15 Mar 2024
- Primary completion14 Mar 2027 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Undergoing DMEK With a History of Anterior or Posterior Segment SurgeryStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Alain SAAD, Principal investigator, Fondation Ophtalmologique A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06013462
- Sponsor's protocol ID
- ASD_2023_6
- Acronym
- DMEK complexes
- Status last verified
- Dec 2025
- First submitted
- 21 Aug 2023
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DMEK Endothelial Keratoplasty in Patients With a History of Anterior or Posterior Segment Surgery : Serious Complication Rate and Visual Efficacy at 12 Months
- ClinicalTrials.gov ID
- NCT06013462
- Acronym / sponsor ID
- DMEK complexes / ASD_2023_6
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 14 Mar 2027 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 28 Aug 2023 (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.
DMEK (Descemet Membrane Endothelial Keratoplasty) is a surgical technique used to treat primary or secondary corneal endothelial decompensation. At the Rothschild Foundation, as in many Western referral centers, DMEK is currently the surgical technique of choice for the treatment of primary or secondary corneal endothelial decompensation.
Technically challenging, it is a relatively tedious surgery to learn, but offers the best visual and refractive results, as well as faster visual and functional recovery in simple cases.
In patients without anterior or posterior segment surgical history, the complication rate of DMEK, including graft rejection, is similar to that of other endothelial keratoplasty surgical techniques.
However, in specific cases, in patients with a history of ophthalmological surgery such as vitrectomy, trabeculectomy, large iris defects, anterior synechiae, aniridia or aphakia, the scientific literature shows a higher complication rate for DMEK (increased rate of rebulling and graft decompensation).
As a result, other techniques that are less effective on visual results continue to be used for these patients in a large number of centers.
Nonetheless, in our department, DMEK is also performed on these complicated patients.
When it comes to patients with a history of anterior or posterior segment surgery, it seems to us that the surgeons' experience with DMEK allows better visual results than with any other technique, but without any back up regarding the complication rate in the literature.
The main aim of this study is to describe, in patients with a history of anterior or posterior segment surgery undergoing DMEK, the 12-months occurrence rate of at least one serious post-operative complication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Group of 80 patients admitted for consultation at the Hôpital Fondation Adolphe de Rothschild up to one year prior to endothelial transplantation and meeting the above eligibility criteria.
Key inclusion criteria (5 listed)
- Patients scheduled for corneal endothelial transplantation in one or both eyes
- History of vitrectomy, trabeculectomy, large iris defects, anterior synechiae on the eye to be operated on
- Pseudophakia or aphakia in the eye to be operated on
- Express consent to participate in the study
- Affiliated or beneficiary of a social security scheme
Key exclusion criteria (11 listed)
- Need for combined PKE + EK surgery
- Primary endothelial decompensation
- At least one contraindication to endothelial transplantation :
- Medical contraindication to general or local anesthesia
- Patient under legal protection
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 KeratoplastyDMEK (Descemet Membrane Endothelial Keratoplasty) is a surgical technique used to treat primary or secondary corneal endothelial decompensation. | Procedure or surgery | – |
Primary outcome
Occurrence rate of at least one serious DMEK post-op complication
Time frame: 12 months
Composite endpoint made of 4 serious post-op complications : * Rebulling : graft detachment of more than one-third of its surface area one week after surgery (on Avanti OCT-cornea), requiring air or gas injection in the anterior chamber. * Graft failure : no improvement in pachymetry at three months post-op (Avanti OCT-cornea). * Graft rejection : presence of cellular Tyndall in the anterior chamber and/or retro-descemetic precipitates and/or focal or diffuse increase in pachymetry > 20μm (Avanti OCT-cornea and slit-lamp biomicroscopic examination). * Macular cystoid edema : presence of intraretinal fluid in the macular area (macular OCT).
28 secondary outcomes
Rebulling occurrence rate
Time frame: 12 months
Graft failure occurrence rate
Time frame: 12 months
Graft rejection occurrence rate
Time frame: 12 months
Macular cystoid edema occurrence rate
Time frame: 12 months
Intraocular hypertension occurrence rate
Time frame: 12 months
Graft detachment (with or without rebulling) occurrence rate
Time frame: 12 months
Surgeon's subjective assessment of surgical complexity
Time frame: Right after the completion of the surgery
Duration of surgical procedure (in minutes)
Time frame: Right after the completion of the surgery
Evolution of visual results (corrected and uncorrected)
Time frame: 1 month after surgery
Evolution of visual results (corrected and uncorrected)
Time frame: 3 months after surgery
Evolution of visual results (corrected and uncorrected)
Time frame: 6 months after surgery
Evolution of visual results (corrected and uncorrected)
Time frame: 12 months after surgery
Evolution of refractive results
Time frame: 1 month after surgery
Evolution of refractive results
Time frame: 3 months after surgery
Evolution of refractive results
Time frame: 6 months after surgery
Evolution of refractive results
Time frame: 12 months after surgery
Evolution of endothelial loss
Time frame: 1 month after surgery
Evolution of endothelial loss
Time frame: 3 months after surgery
Evolution of endothelial loss
Time frame: 6 months after surgery
Evolution of endothelial loss
Time frame: 12 months after surgery
Evolution of corneal thickness
Time frame: 1 month after surgery
Evolution of corneal thickness
Time frame: 3 months after surgery
Evolution of corneal thickness
Time frame: 6 months after surgery
Evolution of corneal thickness
Time frame: 12 months after surgery
Evolution of posterior keratometry
Time frame: 1 month after surgery
Evolution of posterior keratometry
Time frame: 3 months after surgery
Evolution of posterior keratometry
Time frame: 6 months after surgery
Evolution of posterior keratometry
Time frame: 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
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.
Alain SAAD principal investigator
Fondation Ophtalmologique A. de Rothschild
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 Patients Undergoing DMEK With a History of Anterior or Posterior Segment Surgery, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 8 Dec 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amélie YAVCHITZ (01.48.03.64.33 ext. +33, ayavchitz@for.paris), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence rate of at least one serious DMEK post-op complication (time frame: 12 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 8 Dec 2025.