Comparison of Two Techniques in Achieving Corneal Graft

Comparison of Manual and Automated Techniques in Achieving Posterior Lamellar Transplantation of the Cornea

The cornea is a transparent membrane, half a millimeter thick, embedded as a window in front of the eye.

When the eye becomes opaque, the eye is not seeing and the only way to restore the visual acuity is to replace the cornea by performing a graft (4000 surgeries per year in France). In half the cases the opacification of the cornea is secondary to dysfunction of the endothelium, cell layer of 15 μm thickness, covering its posterior surface, in charge of regulating the moisture of the corneal thickness and therefore its transparency.

While the total corneal transplantation has long been the only intervention for these diseases, it is now possible, from 4-5 years, to replace only the very thin: it is called endothelial transplant or graft lamellar later. This intervention is now experiencing significant success as it reduces very significantly the incidence of complications found after transplantation of total cornea and the visual recovery period. This type of transplant is still difficult to achieve and the best technique is not yet established.

Indeed, posterior lamellar transplantation of the cornea may be done manually or using an automated device. Manual techniques allow the preparation of grafts extremely thin but are difficult to achieve while the automatic techniques, easier, prepare thicker grafts that may be less efficient in visual recovery.

The aim of this project is to conduct a prospective study in order to compare these two techniques in terms of postoperative visual recovery and the vitality of the graft during the first year. To date, there is no such study.

The department of Ophthalmology in the University Hospital of Rouen is one of the most famous French teams in the field of cornea transplants and receives many patients from different French regions. The recruitment of 40 patients needed to study should be done without great difficulty over a period of 18 months.

Study Overview

• Status: Completed
• Conditions: Fuch's Endothelial Dystrophy
• Intervention / Treatment: Procedure: Endothelial descemet membrane graft

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rouen, France, 76031
    • UH Rouen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• men and woman
• 18 years old or more
• Patient having been informed about the study and having signed a non-opposition to the participation

Exclusion Criteria:

• Patient presenting an associated eye pathology previously known and able to limit the visual recovery (age-related macular degeneration, diabetic retinopathy, ...)
• Pregnant women, parturient or breast feeding
• refusal to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Manual preparation; Manual preparation of the graft	Procedure: Endothelial descemet membrane graft; Standard Endothelial descemet membrane graft
ACTIVE_COMPARATOR: Automatized preparation; Automatized preparation of the graft with microkeratoma	Procedure: Endothelial descemet membrane graft; Standard Endothelial descemet membrane graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measurement of visual acuity	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occular hypertension	Measurement of occular hypertension	Day 7, Day 15, Month 1, Month 2, Month 6, 1 year
Measurement of visual acuity		Month 1, Month 2, Month 6
Partial or complete graft detachment	% of detachment	Day 7, Day 15, Month 1, Month 2, Month 6, 1 year
Necessity of air injection	Necessity of air injection : yes/no	Day 7, Day 15, Month 1, Month 2, Month 6, 1 year
Defeat of the graft	Defeat of the graft : yes/no	Day 7, Day 15, Month 1, Month 2, Month 6, 1 year

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Marc MURAINE, Pr, UH Rouen

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ACTUAL): August 1, 2016
• Study Completion (ACTUAL): August 1, 2016

Study Registration Dates

• First Submitted: April 25, 2012
• First Submitted That Met QC Criteria: June 1, 2012
• First Posted (ESTIMATE): June 4, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 10, 2016
• Last Update Submitted That Met QC Criteria: October 7, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Fuch's dystrophy; Corneal graft
• Additional Relevant MeSH Terms: Eye Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Corneal Diseases; Corneal Dystrophies, Hereditary; Fuchs' Endothelial Dystrophy
• Other Study ID Numbers: 2010/084/HP; 2011-A00221-40