Treatment of Keratoconus With PALK Versus PK

Overview

The purpose of this study is to evaluate the visual results of patients with keratoconus treated with one of two techniques: penetrating keratoplasty (PK) vs. pachymetry and Excimer laser assisted lamellar keratoplasty (PALK).

Full Title of Study: “Treatment of Keratoconus With Pachymetry Assisted Laser Keratoplasty (PALK) Versus Penetrating Keratoplasty (PK)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2014

Interventions

  • Procedure: Penetrating keratoplasty
    • Conventional Penetrating keratoplasty technique
  • Procedure: Pachymetry and Excimer laser assisted lamellar keratoplasty
    • Ablation profile focusing on topography and pachymetry with Schwind Amaris excimer laser
  • Drug: Treatment posterior to surgery
    • Fluoroquinolone topical antibiotic (Moxifloxacin, Vigamox) and topical steroid (Prednisolone Acetate Ophthalmic Suspension, Pred Forte)

Arms, Groups and Cohorts

  • Experimental: Penetrating keratoplasty
    • Conventional penetrating keratoplasty technique
  • Experimental: PALK
    • Pachymetry and Excimer laser assisted lamellar keratoplasty

Clinical Trial Outcome Measures

Primary Measures

  • Visual acuity
    • Time Frame: 6 months
    • Uncorrected and corrected distance visual acuity

Secondary Measures

  • Corneal measurements: pachymetry
    • Time Frame: 6 months
    • Evaluation of the pachymetric maps with a Scheimpflug-Placido device (Sirius). Measurement in microns
  • Corneal aberrometry: Coma, spherical aberration and trefoil
    • Time Frame: 6 months
    • Evaluation of the corneal aberrations including coma, spherical aberration and trefoil, with a Scheimpflug-Placido device (Sirius)
  • Corneal measurements: anterior and posterior elevation
    • Time Frame: 6 months
    • Evaluation of the elevation (anterior and posterior), maps with a Scheimpflug-Placido device (Sirius). Measurement in diopters
  • Corneal measurements: keratometries.
    • Time Frame: 6 months
    • Evaluation of the keratometric map with a Scheimpflug-Placido device (Sirius). Measurement in diopters

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of keratoconus grades III or IV in the Amsler Krumeich classification. – Need of surgical procedure – No endothelial scar – Best corrected visual acuity <20/40 – Contact lens intolerance – Imagenological map pachymetric acquisition over 90% at 9 mm corneal diameter Exclusion Criteria:

  • Contraindication for any of the techniques evaluated. – Requiring additional surgical procedures. – Diagnostic of other ectasia that were not primary keratoconus.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Instituto de Oftalmología Fundación Conde de Valenciana
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Enrique Graue Hernandez, MD, MsC, Study Director, Instituto de Oftalmologia Conde de Valenciana

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