NCT01610973

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

October 10, 2016

Status Verified

October 1, 2016

Enrollment Period

4.2 years

First QC Date

April 25, 2012

Last Update Submit

October 7, 2016

Conditions

Fuch's Endothelial Dystrophy

Keywords

Fuch's dystrophyCorneal graft

Outcome Measures

Primary Outcomes (1)

  • Measurement of visual acuity

    1 year

Secondary Outcomes (5)

  • 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

    Day 7, Day 15, Month 1, Month 2, Month 6, 1 year

  • Necessity of air injection

    Day 7, Day 15, Month 1, Month 2, Month 6, 1 year

  • Defeat of the graft

    Day 7, Day 15, Month 1, Month 2, Month 6, 1 year

Study Arms (2)

Manual preparation

EXPERIMENTAL

Manual preparation of the graft

Procedure: Endothelial descemet membrane graft

Automatized preparation

ACTIVE COMPARATOR

Automatized preparation of the graft with microkeratoma

Procedure: Endothelial descemet membrane graft

Interventions

Endothelial descemet membrane graftPROCEDURE

Standard Endothelial descemet membrane graft

Manual preparation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Rouen

Rouen, 76031, France

Location

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

Corneal Dystrophies, HereditaryCorneal DiseasesEye DiseasesEye Diseases, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Marc MURAINE, Pr

    UH Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2012

First Posted

June 4, 2012

Study Start

June 1, 2012

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

October 10, 2016

Record last verified: 2016-10

Locations

FR(1)