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Treatment of Keratoconus With PALK Versus PK

Primary Purpose

Keratoconus

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Penetrating keratoplasty
Pachymetry and Excimer laser assisted lamellar keratoplasty
Treatment posterior to surgery
Sponsored by
Instituto de Oftalmología Fundación Conde de Valenciana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring Keratoconus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Penetrating keratoplasty

    PALK

    Arm Description

    Conventional penetrating keratoplasty technique

    Pachymetry and Excimer laser assisted lamellar keratoplasty

    Outcomes

    Primary Outcome Measures

    Visual acuity
    Uncorrected and corrected distance visual acuity

    Secondary Outcome Measures

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

    Full Information

    First Posted
    December 1, 2015
    Last Updated
    December 5, 2015
    Sponsor
    Instituto de Oftalmología Fundación Conde de Valenciana
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02625467
    Brief Title
    Treatment of Keratoconus With PALK Versus PK
    Official Title
    Treatment of Keratoconus With Pachymetry Assisted Laser Keratoplasty (PALK) Versus Penetrating Keratoplasty (PK)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2013 (undefined)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    November 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Instituto de Oftalmología Fundación Conde de Valenciana

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Keratoconus
    Keywords
    Keratoconus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    28 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Penetrating keratoplasty
    Arm Type
    Experimental
    Arm Description
    Conventional penetrating keratoplasty technique
    Arm Title
    PALK
    Arm Type
    Experimental
    Arm Description
    Pachymetry and Excimer laser assisted lamellar keratoplasty
    Intervention Type
    Procedure
    Intervention Name(s)
    Penetrating keratoplasty
    Intervention Description
    Conventional Penetrating keratoplasty technique
    Intervention Type
    Procedure
    Intervention Name(s)
    Pachymetry and Excimer laser assisted lamellar keratoplasty
    Intervention Description
    Ablation profile focusing on topography and pachymetry with Schwind Amaris excimer laser
    Intervention Type
    Drug
    Intervention Name(s)
    Treatment posterior to surgery
    Intervention Description
    Fluoroquinolone topical antibiotic (Moxifloxacin, Vigamox) and topical steroid (Prednisolone Acetate Ophthalmic Suspension, Pred Forte)
    Primary Outcome Measure Information:
    Title
    Visual acuity
    Description
    Uncorrected and corrected distance visual acuity
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Corneal measurements: pachymetry
    Description
    Evaluation of the pachymetric maps with a Scheimpflug-Placido device (Sirius). Measurement in microns
    Time Frame
    6 months
    Title
    Corneal aberrometry: Coma, spherical aberration and trefoil
    Description
    Evaluation of the corneal aberrations including coma, spherical aberration and trefoil, with a Scheimpflug-Placido device (Sirius)
    Time Frame
    6 months
    Title
    Corneal measurements: anterior and posterior elevation
    Description
    Evaluation of the elevation (anterior and posterior), maps with a Scheimpflug-Placido device (Sirius). Measurement in diopters
    Time Frame
    6 months
    Title
    Corneal measurements: keratometries.
    Description
    Evaluation of the keratometric map with a Scheimpflug-Placido device (Sirius). Measurement in diopters
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Enrique Graue Hernandez, MD, MsC
    Organizational Affiliation
    Instituto de Oftalmologia Conde de Valenciana
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Treatment of Keratoconus With PALK Versus PK

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