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Completed

NCT Number: NCT01610973

Comparison of Two Techniques in Achieving Corneal Graft

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UH Rouen

Rouen, 76031, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endothelial descemet membrane graft

Procedure

Standard Endothelial descemet membrane graft

Primary outcomes

  1. Measurement of visual acuity

    Time frame: 1 year

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jun 4, 2012
Registry last updated
Oct 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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