|
Welcome
|
|
11 February 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| PENTACON Trial: Partial ENdothelial Trepanation in Addition to Anterior Lamellar Keratoplasty in keratoCONus |
| ISRCTN | ISRCTN39068025 |
| ClinicalTrials.gov identifier | NCT01145937 |
| Public title | PENTACON Trial: Partial ENdothelial Trepanation in Addition to Anterior Lamellar Keratoplasty in keratoCONus |
| Scientific title | Partial endothelial trepanation in addition to anterior lamellar keratoplasty in keratoconus: a randomised controlled open-label parallel interventional trial |
| Acronym | PENTACON trial |
| Serial number at source | 30756.041.10 |
| 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. |
| Lay summary | |
| 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 |
| Countries of recruitment | Netherlands |
| Disease/condition/study domain | Keratoconus |
| Participants - 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 |
| Participants - 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.) |
| Anticipated start date | 01/07/2010 |
| Anticipated end date | 01/05/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet (Dutch only) |
| Target number of participants | 80 |
| Interventions |
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). |
| Primary outcome measure(s) | Peroperative corneal perforation |
| Secondary outcome measure(s) |
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 |
| Sources of funding |
1. University Medical Center Utrecht (UMCU) (Netherlands) - Department of Ophthalmology
2. Dr. F.P. Fischer Stichting (Netherlands) |
| Trial website | |
| Publications | |
| Contact name | Dr Robert Wisse |
| Address |
University Medical Center Utrecht
p/a Drs. R.P.L. Wisse, E.03.136 Postbus 85500 |
| City/town | Utrecht |
| Zip/Postcode | 3508 GA |
| Country | Netherlands |
| Tel | +31 (0)88 755 6780 |
| Fax | +31 (0)88 755 5417 |
| r.p.l.wisse@umcutrecht.nl | |
| Sponsor | Dr. F.P. Fischer Stichting (Netherlands) |
| Address | Postbus 2756 |
| City/town | Amersfoort |
| Zip/Postcode | 3800 GJ |
| Country | Netherlands |
| Sponsor website: | http://www.lsbs.nl/uitzicht/uk/ |
| Date applied | 16/06/2010 |
| Last edited | 11/08/2010 |
| Date ISRCTN assigned | 11/08/2010 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|