Comparison of Two Techniques in Achieving Corneal Graft

Fuch's Endothelial Dystrophy Clinical Trial

Official title:

Comparison of Manual and Automated Techniques in Achieving Posterior Lamellar Transplantation of the Cornea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01610973
• Other study ID #: 2010/084/HP
• Secondary ID: 2011-A00221-40
• Status: Completed
• Phase: N/A
• First received: April 25, 2012
• Last updated: October 7, 2016
• Start date: June 2012
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fuch's Endothelial Dystrophy
• Fuchs' Endothelial Dystrophy

Intervention

Procedure:
• Endothelial descemet membrane graft
Standard Endothelial descemet membrane graft
• Endothelial descemet membrane graft
Standard Endothelial descemet membrane graft

Locations

Country	Name	City	State
France	UH Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of visual acuity		1 year	No
Secondary	Occular hypertension	Measurement of occular hypertension	Day 7, Day 15, Month 1, Month 2, Month 6, 1 year	Yes
Secondary	Measurement of visual acuity		Month 1, Month 2, Month 6	No
Secondary	Partial or complete graft detachment	% of detachment	Day 7, Day 15, Month 1, Month 2, Month 6, 1 year	Yes
Secondary	Necessity of air injection	Necessity of air injection : yes/no	Day 7, Day 15, Month 1, Month 2, Month 6, 1 year	Yes
Secondary	Defeat of the graft	Defeat of the graft : yes/no	Day 7, Day 15, Month 1, Month 2, Month 6, 1 year	Yes