Comparison of Two Techniques in Achieving Corneal Graft
Primary Purpose
Fuch's Endothelial Dystrophy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Endothelial descemet membrane graft
Endothelial descemet membrane graft
Sponsored by
About this trial
This is an interventional treatment trial for Fuch's Endothelial Dystrophy focused on measuring Fuch's dystrophy, Corneal graft
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
Sites / Locations
- UH Rouen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Manual preparation
Automatized preparation
Arm Description
Manual preparation of the graft
Automatized preparation of the graft with microkeratoma
Outcomes
Primary Outcome Measures
Measurement of visual acuity
Secondary Outcome Measures
Occular hypertension
Measurement of occular hypertension
Measurement of visual acuity
Partial or complete graft detachment
% of detachment
Necessity of air injection
Necessity of air injection : yes/no
Defeat of the graft
Defeat of the graft : yes/no
Full Information
NCT ID
NCT01610973
First Posted
April 25, 2012
Last Updated
October 7, 2016
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT01610973
Brief Title
Comparison of Two Techniques in Achieving Corneal Graft
Official Title
Comparison of Manual and Automated Techniques in Achieving Posterior Lamellar Transplantation of the Cornea
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fuch's Endothelial Dystrophy
Keywords
Fuch's dystrophy, Corneal graft
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Manual preparation
Arm Type
Experimental
Arm Description
Manual preparation of the graft
Arm Title
Automatized preparation
Arm Type
Active Comparator
Arm Description
Automatized preparation of the graft with microkeratoma
Intervention Type
Procedure
Intervention Name(s)
Endothelial descemet membrane graft
Intervention Description
Standard Endothelial descemet membrane graft
Intervention Type
Procedure
Intervention Name(s)
Endothelial descemet membrane graft
Intervention Description
Standard Endothelial descemet membrane graft
Primary Outcome Measure Information:
Title
Measurement of visual acuity
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Occular hypertension
Description
Measurement of occular hypertension
Time Frame
Day 7, Day 15, Month 1, Month 2, Month 6, 1 year
Title
Measurement of visual acuity
Time Frame
Month 1, Month 2, Month 6
Title
Partial or complete graft detachment
Description
% of detachment
Time Frame
Day 7, Day 15, Month 1, Month 2, Month 6, 1 year
Title
Necessity of air injection
Description
Necessity of air injection : yes/no
Time Frame
Day 7, Day 15, Month 1, Month 2, Month 6, 1 year
Title
Defeat of the graft
Description
Defeat of the graft : yes/no
Time Frame
Day 7, Day 15, Month 1, Month 2, Month 6, 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc MURAINE, Pr
Organizational Affiliation
UH Rouen
Official's Role
Principal Investigator
Facility Information:
Facility Name
UH Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
12. IPD Sharing Statement
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Comparison of Two Techniques in Achieving Corneal Graft
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