Predictive Factors of Graft Detachment Following Dmek

NCT05531760 | Completed

• 1 other identifier: 2022-10Obs-CHRMT
• Study Type: observational
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to identify the predictive factors of graft detachment after Descemet Membrane Endothelial Keratoplasty (DMEK) surgery. This retrospective study was conducted on patients aged 18 years, with Fuchs' dystrophy (FECD) or pseudophakic bullous keratopathy (PBK), who were scheduled for DMEK or triple-DMEK (combined phacoemulsification and DMEK surgery). Patients with a history of surgery other than cataract surgery were excluded. The study was conducted between 2014 and 2022 and follow-up was for 3 months. The characteristics of patients with and without graft detachment following surgery were compared using logistic regression.

Conditions

Fuchs' Endothelial Corneal Dystrophy; Descemet Membrane Endothelial Keratoplasty; Pseudophakic Bullous Keratopathy; Graft Detachment

Outcome Measures

Primary Outcomes (1)

• Appearence of the graft on anterior segment optical coherence tomography (AS OCT) examination

  clinical examination and anterior segment optical coherence tomography (AS OCT) examination (appearence of the graft)

  up to 3 months after surgery

Study Arms (2)

DMEK-operated eyes without graft detachment

Eyes operated with DMEK without graft detachment

Procedure: Descemet Membrane Endothelial Keratoplasty

DMEK-operated with graft detachment

Eyes operated with DMEK with graft detachment

Procedure: Descemet Membrane Endothelial Keratoplasty

Interventions

Descemet Membrane Endothelial Keratoplasty PROCEDURE

DMEK-operated eyes

DMEK-operated eyes without graft detachment; DMEK-operated with graft detachment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with fuchs endothelial corneal dystrophy and patients with pseudophakic bullous keratopathies requiring corneal transplantation

You may qualify if:

• Patients over 18 years of age with DMEK surgery

You may not qualify if:

• all associated eye surgery other than cataract surgery
• all existing anterior segment anomalies

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (1)

CHR Metz-Thionville/Hopital de Mercy

Metz, 57085, France

Location

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; 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 Hopital de Mercy

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 8, 2022
• Study Start: March 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: September 8, 2022

Record last verified: 2022-09

Locations

FR (1)