PENTACON Trial: Partial ENdothelial Trepanation in Addition to Anterior Lamellar Keratoplasty in keratoCONus
| ISRCTN | ISRCTN39068025 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39068025 |
| ClinicalTrials.gov (NCT) | NCT01145937 |
| Protocol serial number | 30756.041.10 |
| Sponsor | Dr. F.P. Fischer Stichting (Netherlands) |
| Funders | University Medical Center Utrecht (UMCU) (Netherlands) - Department of Ophthalmology, Dr. F.P. Fischer Stichting (Netherlands) |
- Submission date
- 16/06/2010
- Registration date
- 11/08/2010
- Last edited
- 24/07/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Robert Wisse
Scientific
Scientific
University Medical Center Utrecht
p/a Drs. R.P.L. Wisse, E.03.136
Postbus 85500
Utrecht
3508 GA
Netherlands
| Phone | +31 (0)88 755 6780 |
|---|---|
| r.p.l.wisse@umcutrecht.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled open-label parallel interventional trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Partial endothelial trepanation in addition to anterior lamellar keratoplasty in keratoconus: a randomised controlled open-label parallel interventional trial |
| Study acronym | PENTACON |
| Study objectives | 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(s) | Medisch Etische Toetsings Commissie (Medical Ethical Approval Board) of University Medical Center Utrecht approved on the 25th April 2010 (ref: 30756.041.10) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
Peroperative corneal perforation |
| Key secondary outcome measure(s) |
1. Best corrected visual acuity one year post-operation |
| Completion date | 01/05/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 80 |
| Key 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 |
| Key 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.) |
| Date of first enrolment | 01/03/2011 |
| Date of final enrolment | 01/05/2015 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Utrecht
Utrecht
3508 GA
Netherlands
3508 GA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
24/07/2020: Thesis added.
11/04/2019: No publications found, verifying study status with principal investigator.
