Condition category
Eye Diseases
Date applied
26/02/2007
Date assigned
26/02/2007
Last edited
17/10/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rudy M M A Nuijts

ORCID ID

Contact details

University Hospital Maastricht
Department of Ophthalmology
P.O. Box 5800
Maastricht
6202 AZ
Netherlands
+31 (0)43 387 7344
rnu@soog.azm.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ZonMw-945-04-454; NTR834

Study information

Scientific title

Acronym

DLCTS-study

Study hypothesis

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

Received from the local medical ethics committee

Study design

Randomised, active controlled, parallel group, multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/01/2005

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

140

Participant exclusion criteria

Does not comply with the above inclusion criteria

Recruitment start date

01/01/2005

Recruitment end date

01/01/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Hospital Maastricht
Maastricht
6202 AZ
Netherlands

Sponsor information

Organisation

University Hospital Maastricht (The Netherlands)

Sponsor details

Department of Ophthalmology
P.O. Box 616
Maastricht
6200 MD
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.unimaas.nl/

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Dutch Association of the Blind and Partially Sighted (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Netherlands Society for the Prevention of Blindness (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21236411
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21683332
3. 2012 economic evaluation in http://www.ncbi.nlm.nih.gov/pubmed/22541659

Publication citations

  1. Results

    van den Biggelaar FJ, Cheng YY, Nuijts RM, Schouten JS, Wijdh RJ, Pels E, van Cleynenbreugel H, Eggink CA, Zaal MJ, Rijneveld WJ, Dirksen CD, Economic evaluation of deep anterior lamellar keratoplasty versus penetrating keratoplasty in The Netherlands., Am. J. Ophthalmol., 2011, 151, 3, 449-59.e2, doi: 10.1016/j.ajo.2010.09.012.

  2. Results

    Cheng YY, van den Berg TJ, Schouten JS, Pels E, Wijdh RJ, van Cleynenbreugel H, Eggink CA, Rijneveld WJ, Nuijts RM, Quality of vision after femtosecond laser-assisted descemet stripping endothelial keratoplasty and penetrating keratoplasty: a randomized, multicenter clinical trial., Am. J. Ophthalmol., 2011, 152, 4, 556-566.e1, doi: 10.1016/j.ajo.2011.03.012.

  3. Economic evaluation

    van den Biggelaar FJ, Cheng YY, Nuijts RM, Schouten JS, Wijdh RJ, Pels E, van Cleynenbreugel H, Eggink CA, Rijneveld WJ, Dirksen CD, Economic evaluation of endothelial keratoplasty techniques and penetrating keratoplasty in the Netherlands., Am. J. Ophthalmol., 2012, 154, 2, 272-281.e2, doi: 10.1016/j.ajo.2012.02.023.

Additional files

Editorial Notes