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

NCT04424550 | Completed

• 1 other identifier: 2020-01Obs-CHRMT
• Study Type: observational
• Target: 218
• Locations: 1 country
• Sites: 1

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.

Conditions

Corneal Dystrophy

Keywords

DMEK, DSAEK, UT-DSAEK, Endothelial cell

Outcome Measures

Primary Outcomes (3)

• visual acuity

  The primary endpoint was best spectacle corrected visual acuity (BSCVA) in logMAR at 6 months

  6 months

• visual acuity

  The primary endpoint was best spectacle corrected visual acuity (BSCVA) in logMAR at 12 months

  12 months

• visual acuity

  The primary endpoint was best spectacle corrected visual acuity (BSCVA) in logMAR at 24 months

  24 months

Secondary Outcomes (9)

• central graft thickness measurements

  6 months

• Type of endothelial graft

  days 1

• Donor's ages

  days 1

• recipient's ages

  day 1

• Graft's endothelial cell density

  day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• Patients with pathologies that may seriously affect VA postoperatively

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (1)

Chr Metz Thionville

Metz, 57085, France

Location

Related Publications (2)

• Perone JM, Goetz C, Zevering Y, Derumigny A. Principal Component Analysis of a Real-World Cohort of Descemet Stripping Automated Endothelial Keratoplasty and Descemet Membrane Endothelial Keratoplasty Cases: Demonstration of a Powerful Data-Mining Technique for Identifying Areas of Research. Cornea. 2025 Feb 1;44(2):209-220. doi: 10.1097/ICO.0000000000003584. Epub 2024 May 29.

  PMID: 38830189 DERIVED

• Perone JM, Goetz C, Zevering Y, Derumigny A, Bloch F, Vermion JC, Lhuillier L. Graft Thickness at 6 Months Postoperatively Predicts Long-Term Visual Acuity Outcomes of Descemet Stripping Automated Endothelial Keratoplasty for Fuchs Dystrophy and Moderate Phakic Bullous Keratopathy: A Cohort Study. Cornea. 2022 Nov 1;41(11):1362-1371. doi: 10.1097/ICO.0000000000002872. Epub 2021 Oct 22.

  PMID: 34690269 DERIVED

MeSH Terms

Conditions

Corneal Dystrophies, Hereditary

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jean Marc PERONE, MD

  CHR Metz Thionville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 11, 2020
• Study Start: August 1, 2017
• Primary Completion: August 1, 2019
• Study Completion: August 1, 2019
• Last Updated: June 11, 2020

Record last verified: 2020-05

Locations

FR (1)