More efficient use of corneal donations: the Dutch Lamellar Corneal Transplantation Study

Completed

• Conditions: Corneal disorders; Eye Diseases

• Registration Number: ISRCTN02191620
• Lead Sponsor: niversity Hospital Maastricht (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-26
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

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) less than 0.4
4. Patients who signed the informed consent

Posterior lamellar keratoplasty:
1. Endothelial dysfunction caused by pseudophakic or aphakic corneal oedema
2. (Fuchs?) Endothelial dystrophy
3. BSCVA less than 0.4
4. Without severe scarring of the anterior stromal cornea
5. Patients who signed the informed consent

Exclusion Criteria

Does not comply with the above inclusion criteria

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
1. Visual acuity<br>2. Astigmatism<br>3. Stray light evaluation<br>4. Contrast sensitivity<br>5. Endothelial cell loss<br>6. Incidence endothelial rejection<br>7. Vision-related quality of life<br>8. Patient satisfaction<br><br>These will be measured before the operation, and at three, six and 12 months after the operation. A full economic evaluation will also be performed.