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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR834 |
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Date of registration:
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11/12/2006 |
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Primary sponsor: |
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Public title:
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More efficient use of corneal donations: the Dutch Lamellar Corneal Transplantation Study.
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Scientific title:
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More efficient use of corneal donations: the Dutch Lamellar Corneal Transplantation Study. - DLCTS-study |
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Date of first enrolment:
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1/1/2005 |
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Target sample size:
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140 |
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Recruitment status: |
recruiting |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=834 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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Rudy M.M.A.
Nuijts |
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Address:
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University Eye Clinic Maastricht
P.O. Box 5800, P. Debyelaan 25
6202 AZ
Maastricht
The Netherlands |
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Telephone:
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+31 (0)43 3877344 |
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Email:
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rudy.nuijts@mumc.nl |
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Affiliation:
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Name:
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Rudy M.M.A.
Nuijts |
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Address:
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University Eye Clinic Maastricht
P.O. Box 5800, P. Debyelaan 25
6202 AZ
Maastricht
The Netherlands |
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Telephone:
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+31 (0)43 3877344 |
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Email:
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rudy.nuijts@mumc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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: 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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Corneal disorders
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Intervention(s)
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Group 1:
Deep Anterior Lamellar Keratoplasty compared to Penetrating Keratoplasty.
Group 2:
Posterior Lamellar Keratoplasty compared to Penetrating Keratoplasty.
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Primary Outcome(s)
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Discard rate of donated corneas.
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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ISRCTN02191620
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ZonMw-945-04-454
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Source(s) of Monetary Support
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ZON-MW, The Netherlands Organization for Health Research and Development, Netherlands Society for the Prevention of Blindness, Dutch Association of the Blind and Partially Sighted
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