Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26035
Enrollment
140
Registered
2006-12-11
Start date
2005-01-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal disorders

Interventions

Group 1: Deep Anterior Lamellar Keratoplasty compared to Penetrating Keratoplasty. Group 2: Posterior Lamellar Keratoplasty compared to Penetrating Keratoplasty.

Sponsors

ZON-MW, The Netherlands Organization for Health Research and Development. University Hospital Maastricht, Department of Ophthalmology
Lead Sponsor

Eligibility

Inclusion criteria

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) < 0.4; 4. Patients who signed the informed consent.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Discard rate of donated corneas.

Secondary

MeasureTime frame
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. A full economic evaluation.

Contacts

Public ContactRudy M.M.A. Nuijts

University Eye Clinic Maastricht P.O. Box 5800

rudy.nuijts@mumc.nl+31 (0)43 3877344

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)