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Completed

NCT Number: NCT04424550

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chr Metz Thionville

Metz, 57085, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Registry information

Official study title

Comparative Long-term Results After DSAEK, UT-DSAEK and DMEK for Fuchs Endothelial Corneal Dystophy and Moderated Pseudophakic Bullous Keratopathy

Acronym: DEMOGRAFT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 11, 2020
Registry last updated
Jun 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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