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

NCT01145937 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2015-12-03

No results posted yet for this study

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

Interventions

PROCEDURE

PET

Partial Endothelial Trepanation in addition to an anterior lamellar keratoplasty

PROCEDURE

DALK

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

Sponsors & Collaborators

  • Dr. F.P. Fischer-stichting, Utrecht, The Netherlands

    collaborator UNKNOWN

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Allegonda Van der Lelij, MD PhD · UMC Utrecht

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2015-05-31
Completion
2015-05-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01145937 on ClinicalTrials.gov