Condition category
Eye Diseases
Date applied
16/06/2010
Date assigned
11/08/2010
Last edited
18/06/2013
Prospective/Retrospective
Prospectively 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 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 measures

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

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

http://www.lsbs.nl/uitzicht/uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes