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Comparison of Two Techniques in Achieving Corneal Graft

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01610973
Recruitment Status : Completed
First Posted : June 4, 2012
Last Update Posted : October 10, 2016
Information provided by (Responsible Party):
University Hospital, Rouen

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.

Condition or disease Intervention/treatment Phase
Fuch's Endothelial Dystrophy Procedure: Endothelial descemet membrane graft Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Manual and Automated Techniques in Achieving Posterior Lamellar Transplantation of the Cornea
Study Start Date : June 2012
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Measurement of visual acuity [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Occular hypertension [ Time Frame: Day 7, Day 15, Month 1, Month 2, Month 6, 1 year ]
    Measurement of occular hypertension

  2. Measurement of visual acuity [ Time Frame: Month 1, Month 2, Month 6 ]
  3. Partial or complete graft detachment [ Time Frame: Day 7, Day 15, Month 1, Month 2, Month 6, 1 year ]
    % of detachment

  4. Necessity of air injection [ Time Frame: Day 7, Day 15, Month 1, Month 2, Month 6, 1 year ]
    Necessity of air injection : yes/no

  5. Defeat of the graft [ Time Frame: Day 7, Day 15, Month 1, Month 2, Month 6, 1 year ]
    Defeat of the graft : yes/no

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01610973

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UH Rouen
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
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Principal Investigator: Marc MURAINE, Pr UH Rouen

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Responsible Party: University Hospital, Rouen Identifier: NCT01610973     History of Changes
Other Study ID Numbers: 2010/084/HP
First Posted: June 4, 2012    Key Record Dates
Last Update Posted: October 10, 2016
Last Verified: October 2016

Keywords provided by University Hospital, Rouen:
Fuch's dystrophy
Corneal graft

Additional relevant MeSH terms:
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Fuchs' Endothelial Dystrophy
Corneal Dystrophies, Hereditary
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn