Contact information
Type
Scientific
Primary contact
Dr Robert Wisse
ORCID ID
Contact details
University Medical Center Utrecht
p/a Drs. R.P.L. Wisse
E.03.136
Postbus 85500
Utrecht
3508 GA
Netherlands
+31 (0)88 755 6780
r.p.l.wisse@umcutrecht.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01145937
Protocol/serial number
30756.041.10
Study information
Scientific title
Partial endothelial trepanation in addition to anterior lamellar keratoplasty in keratoconus: a randomised controlled open-label parallel interventional trial
Acronym
PENTACON trial
Study hypothesis
To investigate the additional value of partial endothelial trepanation (PET) in an anterior lamellar keratoplasty (ALKP) procedure in terms of efficacy and safety in patients with keratoconus, compared in a randomised clinical trial with a regular ALKP procedure.
Please note that as of 18/06/2013, the following changes were made to the trial record:
1. The anticipated start date was updated from 01/07/2010 to 01/03/2011
2. The anticipated end date was updated from 01/05/2013 to 01/05/2015
Ethics approval
Medisch Etische Toetsings Commissie (Medical Ethical Approval Board) of University Medical Center Utrecht approved on the 25th April 2010 (ref: 30756.041.10)
Study design
Randomised controlled open-label parallel interventional trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet (Dutch only)
Condition
Keratoconus
Intervention
Peroperative corneal perforation is the biggest drawback of currently utilised grafting procedures (ALKP, 20 - 30%). Our new technique is believed to be safer, by reducing the number of corneal perforations during surgery. Corneal perforation necessitates converting the procedure to a full-thickness graft with a less favourable long term rejection profile.
To circumvent this perforation problem we utilise a method in which, in addition to an anterior lamellar keratoplasty (ALKP), a partial endothelial trepanation (PET) is performed. This technique was first performed by Massimo Busin, Villa Serena Hopsital, Forli, Italy. The endothelium en Descemet are paracentrally and circular loosened, but some tissue bridges are left in place. This 'island' is able to mould to the healthy donor curvature. By doing this, the surgeon can retain a safer graft thickness margin leading to a lowered number of preoperative perforations. The addition of PET is believed to make corneal grafting safer and more predictable.
The control group will be treatment with a regular ALKP procedure, using the Big Bubble technique according to Anwar et al.
Patients will be randomly assigned to either group A (PET in addiation to ALKP) or group B (regulare ALKP procedure).
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Peroperative corneal perforation
Secondary outcome measures
1. Best corrected visual acuity one year post-operation
2. Manifest refraction one year post-operation
3. Contact lens use (soft/rigid/scleral) or spectacle use
4. Self-rated improvement questionnaire
5. Corneal endothelial function one year post-operation
6. Graft rejection rate
Overall trial start date
01/03/2011
Overall trial end date
01/05/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged equal or above 18 years, either sex
2. Keratoconus as defined and classified by:
2.1. Presence of corneal thinning and protrusion on slit-lamp examination
2.2. Topographic criteria according to keratometry, I-S, astigmatism, and skew percentage (KISA%) index (greater than 100%)
2.3. Mean corneal curvature map
3. Decreased best corrected visual acuity due to corneal scarring or contact lens intolerance
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Prior corneal surgery, cross linking, refractive surgery or other treatment modalities
2. (Localised) corneal thickness less than 200 µm
3. Associated corneal endothelial disease on specular microscopy as defined by:
3.1. Less than 1500 endothelial cells per mm^2
3.2. Polymegathism greater than 0.3
3.3. Pleomorphism less than 0.6 (all are measurements of endothelial dysfunction)
4. Gross ophthalmic pathology surpassing keratoconus as cause of decreased visual acuity
5. Keratoconus-like disease (keratoglobus, pellucid marginal degeneration)
6. Associated corneal anomalies (microcornea, macrocornea, buphthalmos, Peters syndrome, iridocorneal endothelial [ICE]-syndrome, etc.)
Recruitment start date
01/03/2011
Recruitment end date
01/05/2015
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Utrecht
Utrecht
3508 GA
Netherlands
Sponsor information
Organisation
Dr. F.P. Fischer Stichting (Netherlands)
Sponsor details
Postbus 2756
Amersfoort
3800 GJ
Netherlands
Sponsor type
Industry
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Medical Center Utrecht (UMCU) (Netherlands) - Department of Ophthalmology
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Dr. F.P. Fischer Stichting (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
Basic results (scientific)
Publication list