More efficient use of corneal donations: the Dutch Lamellar Corneal Transplantation Study.
- Conditions
- Corneal disorders
- Registration Number
- NL-OMON26035
- Lead Sponsor
- ZON-MW, The Netherlands Organization for Health Research and Development.University Hospital Maastricht, Department of Ophthalmology
- Brief Summary
Yanny Y.Y. Cheng, MD, Elisabeth, PhD, Rudy M.M.A. Nuijts, MD, PhD. "Femtosecond Laser assisted Descemet's Stripping Endothelial Keratoplasty." Journal of Cataract and Refractive Surgery, 2007. In press.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 140
Deep Anterior Lamellar Keratoplasty:
1. Keratoconus intolerant for contact lens wear, without previous hydrops or Descemet’s rupture;
2. Stromal opacification not reaching Descemet’s membrane and without concomitant endothelial disease;
3. Best Spectacle Corrected Visual Acuity (BSCVA) < 0.4;
4. Patients who signed the informed consent.
Posterior Lamellar Keratoplasty:
1. Endothelial dysfunction caused by pseudophakic or aphakic corneal edema;
2. (Fuchs’) Endothelial dystrophy;
3. BSCVA < 0.4;
4. Without severe scarring of the anterior stromal cornea;
5. Patients who signed the informed consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Discard rate of donated corneas.
- Secondary Outcome Measures
Name Time Method Visual acuity, astigmatism, stray light evaluation, contrast sensitivity, endothelial cell loss, incidence endothelial rejection, vision-related quality of life and patient satisfaction. Before operation, and at 3, 6, 12 months after operation. <br>A full economic evaluation. <br>