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Comparative Results After DSAEK, UT-DSAEK and DMEK for Fuchs Endothelial Corneal Dystophy (DEMOGRAFT)

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ClinicalTrials.gov Identifier: NCT04424550
Recruitment Status : Completed
First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Régional Metz-Thionville

Study Description
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Brief Summary:
Purpose of the research is to describe and compare the evolution of BSCVA after DMEK, DSAEK and UT-DSAEK for Fuchs Endothelial Corneal Dystrophy (FECD) and Moderate Pseudophakic Bullous Keratopathy (PBK). To secondarily research the correlates criterions with best spectacle corrected visual acuity (BSCVA) 12 months postoperatively.

Condition or disease
Corneal Dystrophy

Detailed Description:

The purpose of the research is to Describe and compare the evolution of BSCVA after DMEK, DSAEK and UT-DSAEK for Fuchs Endothelial Corneal Dystrophy (FECD) and Moderate Pseudophakic Bullous Keratopathy (PBK). To secondarily research the correlates criterions with best spectacle corrected visual acuity (BSCVA) 12 months postoperatively.

In a retrospective, single-center, observational study, 218 eyes treated with DMEK (n=110), UT-DSAEK (n=58) and DSAEK (n=50) surgeries were studied. Patients requiring posterior lamellar transplantation for FECD or moderate PBK, with preoperative BSCVA of less than 0.3 logmar, were selected. Patients with pathologies that may seriously affect VA postoperatively were excluded. Graft thickness for DSAEK was measured during the surgery and in vivo at D8, D15, M1, M6, M12 and M24. The primary endpoint was best spectacle corrected visual acuity (BSCVA) in logMAR at 6, 12 and 24 months. We deliberately differentiated our postoperative visual results by comparing DMEK with DSAEK or UT-DSAEK with central graft thickness (CGT) measurements carried out either pre-operatively (less than or greater than 130 µm) or post-operatively at 6 months (less than or greater than 100µm). Type of endothelial graft, Donor and recipient's ages, Graft's endothelial cell density (ECD), Rebubbling rate, preoperative VA, graft's indications and surgical time were also tested to explain BSCVA at 12 months.

Study Design
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Study Type : Observational
Actual Enrollment : 218 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Comparative Long-term Results After DSAEK, UT-DSAEK and DMEK for Fuchs Endothelial Corneal Dystophy and Moderated Pseudophakic Bullous Keratopathy
Actual Study Start Date : August 1, 2017
Actual Primary Completion Date : August 1, 2019
Actual Study Completion Date : August 1, 2019
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. visual acuity [ Time Frame: 6 months ]
    The primary endpoint was best spectacle corrected visual acuity (BSCVA) in logMAR at 6 months

  2. visual acuity [ Time Frame: 12 months ]
    The primary endpoint was best spectacle corrected visual acuity (BSCVA) in logMAR at 12 months

  3. visual acuity [ Time Frame: 24 months ]
    The primary endpoint was best spectacle corrected visual acuity (BSCVA) in logMAR at 24 months


Secondary Outcome Measures :
  1. central graft thickness measurements [ Time Frame: 6 months ]
    central graft thickness (CGT) measurements carried out either pre-operatively (less than or greater than 130 µm) or post-operatively at 6 months (less than or greater than 100µm)

  2. Type of endothelial graft [ Time Frame: days 1 ]
    Type of endothelial graft

  3. Donor's ages [ Time Frame: days 1 ]
    Donor's ages

  4. recipient's ages [ Time Frame: day 1 ]
    recipient's ages

  5. Graft's endothelial cell density [ Time Frame: day 1 ]
    Graft's endothelial cell density was evaluated via no-contact specular microscopy (NIDEK CEM-530 NIDEK CO. LTD).

  6. Rebubbling rate [ Time Frame: day 1 ]
    Rebubbling rate

  7. Preoperative visual acuity [ Time Frame: day 1 ]
    Preoperative visual acuity was scored with reference to the logarithm of the minimum angle of resolution (LogMAR).

  8. graft's indications [ Time Frame: day 1 ]
    The indications of the grafts are different between the DMEK groups and the DSAEK and or UT-DSAEK groups: Fuchs endothelial corneal dystrophies (FECD) and moderated pseudophakic bullous keratopathies (PBK)

  9. surgical time [ Time Frame: day 1 ]
    surgical time


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This retrospective study included patients who had undergone posterior lamellar keratoplasty for FECD or moderate PBK indications with a minimum follow-up period of 24 months. The surgical procedures were either DMEK, DSAEK or UT-DSAEK and were performed by the same experienced surgeon (JMP).
Criteria

Inclusion Criteria:

  • Patients requiring posterior lamellar transplantation for FECD or moderate PBK, with preoperative BSCVA of less than 0.3 logmar,

Exclusion Criteria:

  • Patients with pathologies that may seriously affect VA postoperatively
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04424550


Locations
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France
Chr Metz Thionville
Metz, France, 57085
Sponsors and Collaborators
Centre Hospitalier Régional Metz-Thionville
Investigators
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Principal Investigator: Jean Marc PERONE, MD CHR Metz Thionville
More Information
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Responsible Party: Centre Hospitalier Régional Metz-Thionville
ClinicalTrials.gov Identifier: NCT04424550    
Other Study ID Numbers: 2020-01Obs-CHRMT
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Régional Metz-Thionville:
DMEK, DSAEK, UT-DSAEK, Endothelial cell