Comparison of Two Techniques in Achieving Corneal Graft

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University Hospital, Rouen
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT01610973
First received: April 25, 2012
Last updated: September 1, 2014
Last verified: September 2014
  Purpose

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 Intervention
Fuch's Endothelial Dystrophy
Procedure: Endothelial descemet membrane graft

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Manual and Automated Techniques in Achieving Posterior Lamellar Transplantation of the Cornea

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • Measurement of visual acuity [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occular hypertension [ Time Frame: Day 7, Day 15, Month 1, Month 2, Month 6, 1 year ] [ Designated as safety issue: Yes ]
    Measurement of occular hypertension

  • Measurement of visual acuity [ Time Frame: Month 1, Month 2, Month 6 ] [ Designated as safety issue: No ]
  • Partial or complete graft detachment [ Time Frame: Day 7, Day 15, Month 1, Month 2, Month 6, 1 year ] [ Designated as safety issue: Yes ]
    % of detachment

  • Necessity of air injection [ Time Frame: Day 7, Day 15, Month 1, Month 2, Month 6, 1 year ] [ Designated as safety issue: Yes ]
    Necessity of air injection : yes/no

  • Defeat of the graft [ Time Frame: Day 7, Day 15, Month 1, Month 2, Month 6, 1 year ] [ Designated as safety issue: Yes ]
    Defeat of the graft : yes/no


Estimated Enrollment: 40
Study Start Date: June 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01610973

Contacts
Contact: Marc MURAINE, Pr +33232888057 marc.muraine@chu-rouen.fr
Contact: Julien BLOT, Mr +33232888255 julien.blot@chu-rouen.Fr

Locations
France
UH Rouen Recruiting
Rouen, France, 76031
Contact: Marc MURAINE, Pr    +2232888057    marc.muraine@chu-rouen.Fr   
Contact: Julien BLOT, Mr    +33232888265    julien.blot@chu-rouen.fr   
Principal Investigator: Marc MURAINE, Pr         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Principal Investigator: Marc MURAINE, Pr UH Rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01610973     History of Changes
Other Study ID Numbers: 2010/084/HP, 2011-A00221-40
Study First Received: April 25, 2012
Last Updated: September 1, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on October 29, 2014