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

Corneal Dystrophy Clinical Trial

— DEMOGRAFT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04424550
• Other study ID #: 2020-01Obs-CHRMT
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: August 1, 2019

Study information

• Verified date: May 2020
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 218
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Corneal Dystrophy

Locations

Country	Name	City	State
France	Chr Metz Thionville	Metz

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual acuity	The primary endpoint was best spectacle corrected visual acuity (BSCVA) in logMAR at 6 months	6 months
Primary	visual acuity	The primary endpoint was best spectacle corrected visual acuity (BSCVA) in logMAR at 12 months	12 months
Primary	visual acuity	The primary endpoint was best spectacle corrected visual acuity (BSCVA) in logMAR at 24 months	24 months
Secondary	central graft thickness measurements	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)	6 months
Secondary	Type of endothelial graft	Type of endothelial graft	days 1
Secondary	Donor's ages	Donor's ages	days 1
Secondary	recipient's ages	recipient's ages	day 1
Secondary	Graft's endothelial cell density	Graft's endothelial cell density was evaluated via no-contact specular microscopy (NIDEK CEM-530 NIDEK CO. LTD).	day 1
Secondary	Rebubbling rate	Rebubbling rate	day 1
Secondary	Preoperative visual acuity	Preoperative visual acuity was scored with reference to the logarithm of the minimum angle of resolution (LogMAR).	day 1
Secondary	graft's indications	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)	day 1
Secondary	surgical time	surgical time	day 1