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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by UMC Utrecht
Sponsor:
Collaborator:
Dr. F.P. Fischer-stichting, Utrecht, The Netherlands
Information provided by (Responsible Party):
R.P.L. Wisse, MD, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01145937
First received: June 14, 2010
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

Rationale:

Keratoconus is a progressive, non-inflammatory corneal disease in which irregular refractive properties of the cornea result in loss of visual acuity. Treatment is aimed at improving vision, principally using (rigid) contact lenses. With progression of the disease non-correctable refractive abnormalities and/or corneal scars arise. For these advanced stages of keratoconus, a corneal transplant is the only treatment modality.

New surgical grafting modalities have been developed to create partial thickness grafts, according to the location of corneal pathology. For keratoconus, transplanting only the anterior corneal lamellae lowers long-term graft rejection rates. We utilize a method to enhance the safety of the grafting procedure while better visual outcomes are expected.

Objective:

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.

Study design:

A randomized controlled interventional trial

Study population:

Patients over 18 years old with keratoconus in whom contact lens correction is unsuccessful and who are not suitable for corneal crosslinking.

Intervention:

Patients will be randomly assigned to corneal grafting techniques; partial endothelial trepanation in addition to an anterior lamellar keratoplasty (i.e. the PET group) or a regular ALKP procedure.

Study outcomes:

Risk of per-operative perforation. Secondary, factors contributing to treatment safety and efficacy.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

There is no extra burden or risk associated with participation in this study. All measurements are part of normal clinical practice. Adequate experience is available with both surgical techniques. Study participation has no effect on donor selection. If partial endothelial trepanation (PET) is associated with lower complication rates and better visual outcomes, this might be beneficial in terms of morbidity.


Condition Intervention
Keratoconus
Procedure: PET
Procedure: DALK

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pentacon Trial: Partial ENdothelial Trepanation in Addition to Anterior Lamellar Keratoplasty in keratoCONus. A Prospective Multicenter Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Peroperative corneal perforation [ Time Frame: During Surgery. From start to closure of surgical procedure approx. 2h ] [ Designated as safety issue: Yes ]
    Peroperative corneal perforation is the biggest drawback of currently utilized 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.


Secondary Outcome Measures:
  • Best corrected visual acuity one year post op [ Time Frame: One year post-op ] [ Designated as safety issue: No ]
    To determine treatment efficacy visual acuity is assessed one year post-op.

  • Manifest refraction one year post op [ Time Frame: One year post-op ] [ Designated as safety issue: No ]
    Manifest refraction can be grossly altered after corneal grafting procedures. To assess this effect, a manifest refraction one year post-op is obtained.

  • Contact lens use (soft/rigid/scleral) or spectacle use [ Time Frame: one year post-op ] [ Designated as safety issue: No ]
    To assess the dependency on visual aids after corneal grafting. Residual irregular post-op corneal abnormalities can necessitate (rigid) contact lens wear.

  • Self-rated improvement questionnaire [ Time Frame: One year post-op ] [ Designated as safety issue: No ]
    To assess patient satisfaction with treatment outcomes, such as visual acuity, residual refraction etc. This will be measured using the Visual Functioning Questionnaire-25 (Dutch edition).

  • Corneal endothelial function one year post op [ Time Frame: One year post-op ] [ Designated as safety issue: Yes ]
    To assess corneal endothelial function as a measurement for corneal damage sustained during grafting procedure. Endothelial function plays a role in long term corneal decompensation issues.

  • Graft rejection rate [ Time Frame: During one-year follow up period ] [ Designated as safety issue: Yes ]
    Lamellar grafting has proven to lower graft rejection rates. Any graft rejection (endothelial, stromal or epithelial) will be recorded en reported.


Estimated Enrollment: 80
Study Start Date: March 2011
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PET

Partial endothelial trepanation in addition to anterior lamellar keratoplasty.

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.

Procedure: PET
Partial Endothelial Trepanation in addition to an anterior lamellar keratoplasty
Other Name: Busin
Active Comparator: DALK
Conventional DALK grafting procedure where the Big Bubble technique is used according to Anwar et al.
Procedure: DALK
Conventional DALK grafting procedure, with Big Bubble technique according to Anwar et al.
Other Name: ALK

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age equal or above 18 years
  • keratoconus as defined and classified by

    • presence of corneal thinning and protrusion on slit-lamp examination
    • topographic criteria according to KISA% index (>100%)
    • mean corneal curvature map
  • decreased best corrected visual acuity due to corneal scarring or contact lens intolerance

Exclusion Criteria:

  • prior corneal surgery, cross linking, refractive surgery or other treatment modalities
  • (localized) corneal thickness < 200 µm
  • associated corneal endothelial disease on specular microscopy as defined by:

    • <1500 endothelial cells per mm2
    • polymegathism > 0.3
    • pleomorphism < 0.6 (all are measurements of endothelial dysfunction)
  • gross ophthalmic pathology surpassing keratoconus as cause of decreased visual acuity
  • keratoconus-like disease (keratoglobus, pellucid marginal degeneration)
  • associated corneal anomalies (microcornea, macrocornea, buphthalmos, Peters syndrome, ICE-syndrome etc.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01145937

Contacts
Contact: Allegonda Van der Lelij, MD PhD 0031 (0) 887556780 a.vanderlelij@umcutrecht.nl
Contact: Robert Wisse, MD 0031 (0) 887556780 r.p.l.wisse@umcutrecht.nl

Locations
Netherlands
Amphia Ziekenhuis Recruiting
Breda, Netherlands, 4819 EV
Contact: B van Dooren, MD PhD       bvandooren@amphia.nl   
Principal Investigator: B van Dooren, MD PhD         
Westfries Gasthuis Active, not recruiting
Hoorn, Netherlands, 1620 AR
UMCN St. Radboud Recruiting
Nijmegen, Netherlands, 6500HB
Contact: C. Eggink, MD PhD       c.eggink@ohk.umcn.nl   
Principal Investigator: C. Eggink, MD PhD         
Rotterdam Eye Hospital Recruiting
Rotterdam, Netherlands, 3000 LM
Contact: AJM Geerards, MD    0031 (0) 10 4017777      
Principal Investigator: AJM Geerards, MD         
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3508 GA
Contact: R Wisse, MD    0031 (0) 88 7556780    r.p.l.wisse@umcutrecht.nl   
Principal Investigator: Allegonda Van der Lelij, MD PhD         
Sub-Investigator: RPL Wisse, MD         
Sponsors and Collaborators
UMC Utrecht
Dr. F.P. Fischer-stichting, Utrecht, The Netherlands
Investigators
Principal Investigator: Allegonda Van der Lelij, MD PhD UMC Utrecht
  More Information

No publications provided

Responsible Party: R.P.L. Wisse, MD, Ophthalmologist, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01145937     History of Changes
Other Study ID Numbers: 30756.041.10
Study First Received: June 14, 2010
Last Updated: June 10, 2013
Health Authority: Netherlands: Central Committee on Research inv. Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
Keratoconus
Corneal grafting
Corneal transplantation
Anterior Lamellar Keratoplasty

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on October 29, 2014