Comparison of Two Techniques in Achieving Corneal Graft

NCT ID: NCT01610973

Last Updated: 2016-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2016-08-31

Brief Summary

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.

Conditions

Fuch's Endothelial Dystrophy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Manual preparation

Manual preparation of the graft

Group Type: EXPERIMENTAL

Endothelial descemet membrane graft

Intervention Type: PROCEDURE

Standard Endothelial descemet membrane graft

Automatized preparation

Automatized preparation of the graft with microkeratoma

Group Type: ACTIVE_COMPARATOR

Endothelial descemet membrane graft

Intervention Type: PROCEDURE

Standard Endothelial descemet membrane graft

Interventions

Endothelial descemet membrane graft

Standard Endothelial descemet membrane graft

Intervention Type: PROCEDURE

Endothelial descemet membrane graft

Standard Endothelial descemet membrane graft

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Rouen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc MURAINE, Pr

Role: PRINCIPAL_INVESTIGATOR

UH Rouen

Locations

UH Rouen

Rouen, , France

Countries

France

Other Identifiers

2011-A00221-40

Identifier Type: -

Identifier Source: secondary_id

2010/084/HP

Identifier Type: -

Identifier Source: org_study_id