More efficient use of corneal donations: the Dutch Lamellar Corneal Transplantation Study
| ISRCTN | ISRCTN02191620 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02191620 |
| Secondary identifying numbers | ZonMw-945-04-454; NTR834 |
- Submission date
- 26/02/2007
- Registration date
- 26/02/2007
- Last edited
- 17/10/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Rudy M M A Nuijts
Scientific
Scientific
University Hospital Maastricht
Department of Ophthalmology
P.O. Box 5800
Maastricht
6202 AZ
Netherlands
| Phone | +31 (0)43 387 7344 |
|---|---|
| rnu@soog.azm.nl |
Study information
| Study design | Randomised, active controlled, parallel group, multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | DLCTS-study |
| Study objectives | The use of deep anterior lamellar keratoplasty (DALK) and posterior lamellar keratoplasty (PLK) may lead to more efficient use of donor material and could theoretically decrease the current discard rate of donor tissue of 64.8% to 25% and shorten the waiting time from six months to one month. For PLK, we estimate that the induced post-operative astigmatism by the lamellar transplantation technique will be reduced by 50% as compared to conventional penetrating keratoplasty (PKP), that the duration of visual rehabilitation (defined as time point where patients are suitable for spectacle prescription) will decrease from six to three months, that wound dehiscence problems will decrease by 50% and that the incidence of contact lens fitting for high post-operative ametropia and astigmatism will decrease by 75%. For DALK, we estimate a reduction in post-operative astigmatism of 25% as compared to conventional PKP, a decrease in the duration of visual rehabilitation from six to three months, a reduction in wound dehiscence problems by 50%, a decrease in the incidence of contact lens fitting for high post-operative ametropia and astigmatism with 50%, a decrease in endothelial rejection rate by 100%, and a decrease in endothelial cell loss from one month to 24 months post-operatively of 50%. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Corneal disorders |
| Intervention | Group one: Deep anterior lamellar keratoplasty compared to penetrating keratoplasty. Group two: Posterior lamellar keratoplasty compared to penetrating keratoplasty. |
| Intervention type | Other |
| Primary outcome measure | Discard rate of donated corneas. |
| Secondary outcome measures | 1. Visual acuity 2. Astigmatism 3. Stray light evaluation 4. Contrast sensitivity 5. Endothelial cell loss 6. Incidence endothelial rejection 7. Vision-related quality of life 8. Patient satisfaction 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. |
| Overall study start date | 01/01/2005 |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 140 |
| Key inclusion criteria | Deep anterior lamellar keratoplasty: 1. Keratoconus intolerant for contact lens wear, without previous hydrops or Descemets rupture 2. Stromal opacification not reaching Descemets 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 |
| Key exclusion criteria | Does not comply with the above inclusion criteria |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Hospital Maastricht
Maastricht
6202 AZ
Netherlands
6202 AZ
Netherlands
Sponsor information
University Hospital Maastricht (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Ophthalmology
P.O. Box 616
Maastricht
6200 MD
Netherlands
| Website | http://www.unimaas.nl/ |
|---|---|
"ROR" |
https://ror.org/02d9ce178 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
No information available
Dutch Association of the Blind and Partially Sighted (The Netherlands)
No information available
Netherlands Society for the Prevention of Blindness (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2011 | Yes | No | |
| Results article | results | 01/10/2011 | Yes | No | |
| Other publications | economic evaluation | 01/08/2012 | Yes | No |
