PENTACON Trial: Partial ENdothelial Trepanation in Addition to Anterior Lamellar Keratoplasty in keratoCONus

ISRCTN	ISRCTN39068025
DOI	https://doi.org/10.1186/ISRCTN39068025
ClinicalTrials.gov number	NCT01145937
Secondary identifying numbers	30756.041.10

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

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
Email	r.p.l.wisse@umcutrecht.nl

Study information

Study design	Randomised controlled open-label parallel interventional trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet (Dutch only)
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	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 study start date	01/03/2011
Completion date	01/05/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	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

Sponsor information

Dr. F.P. Fischer Stichting (Netherlands)
Industry

Postbus 2756
Amersfoort
3800 GJ
Netherlands

Website	http://www.lsbs.nl/uitzicht/uk/
"ROR"	https://ror.org/000zsjk11

Funders

Funder type

Hospital/treatment centre

University Medical Center Utrecht (UMCU) (Netherlands) - Department of Ophthalmology

No information available

Dr. F.P. Fischer Stichting (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 2015 thesis in https://www.researchgate.net/profile/Robert_Wisse/publication/316463878_Keratoconus_-_Inflammatory_associations_and_treatment_characteristics/links/58ffa1eda6fdcc8ed50db964/Keratoconus-Inflammatory-associations-and-treatment-characteristics.pdf (added 24/07/2020)
IPD sharing plan

Editorial Notes

24/07/2020: Thesis added.
11/04/2019: No publications found, verifying study status with principal investigator.