Clinical trial NCT01610973: 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
Overall status: COMPLETED
Phase: NA
Conditions: Fuch's Endothelial Dystrophy
Keywords: Fuch's dystrophy
Corneal graft
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2012-06-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Measurement of visual acuity
timeFrame: 1 year
Secondary outcomes:
measure: Occular hypertension
timeFrame: Day 7, Day 15, Month 1, Month 2, Month 6, 1 year
measure: Measurement of visual acuity
timeFrame: Month 1, Month 2, Month 6
measure: Partial or complete graft detachment
timeFrame: Day 7, Day 15, Month 1, Month 2, Month 6, 1 year
measure: Necessity of air injection
timeFrame: Day 7, Day 15, Month 1, Month 2, Month 6, 1 year
measure: Defeat of the graft
timeFrame: Day 7, Day 15, Month 1, Month 2, Month 6, 1 year
Other outcomes:
Locations:
city: Rouen
country: France
facility: UH Rouen
Study officials:
affiliation: UH Rouen
name: Marc MURAINE, Pr
role: PRINCIPAL_INVESTIGATOR
References: