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

NCT01145937 | Terminated

• 1 other identifier: 30756.041.10
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Keratoconus

Keywords

Keratoconus; Corneal grafting; Corneal transplantation; Anterior Lamellar Keratoplasty

Outcome Measures

Primary Outcomes (1)

• Peroperative corneal perforation

  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.

  During Surgery. From start to closure of surgical procedure approx. 2h

Secondary Outcomes (6)

• Best corrected visual acuity one year post op

  One year post-op

• Manifest refraction one year post op

  One year post-op

• Contact lens use (soft/rigid/scleral) or spectacle use

  one year post-op

• Self-rated improvement questionnaire

  One year post-op

• Corneal endothelial function one year post op

  One year post-op

Study Arms (2)

PET

EXPERIMENTAL

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

DALK

ACTIVE COMPARATOR

Conventional DALK grafting procedure where the Big Bubble technique is used according to Anwar et al.

Procedure: DALK

Interventions

PET PROCEDURE

Partial Endothelial Trepanation in addition to an anterior lamellar keratoplasty

Also known as: Busin

PET

DALK PROCEDURE

Conventional DALK grafting procedure, with Big Bubble technique according to Anwar et al.

Also known as: ALK

DALK

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• UMC Utrecht: lead
• Dr. F.P. Fischer-stichting, Utrecht, The Netherlands: collaborator

Study Sites (5)

Amphia Ziekenhuis

Breda, 4819 EV, Netherlands

Location

Westfries Gasthuis

Hoorn, 1620 AR, Netherlands

Location

UMCN St. Radboud

Nijmegen, 6500HB, Netherlands

Location

Rotterdam Eye Hospital

Rotterdam, 3000 LM, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3508 GA, Netherlands

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Allegonda Van der Lelij, MD PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ophthalmologist

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 17, 2010
• Study Start: March 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: December 3, 2015

Record last verified: 2015-12

Locations

NL (5)