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OpenTrials
Completed

NCT Number: NCT02625467

Treatment of Keratoconus With PALK Versus PK

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).

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

penetrating keratoplasty

Procedure

Conventional Penetrating keratoplasty technique

Pachymetry and Excimer laser assisted lamellar keratoplasty

Procedure

Ablation profile focusing on topography and pachymetry with Schwind Amaris excimer laser

Treatment posterior to surgery

Drug

Fluoroquinolone topical antibiotic (Moxifloxacin, Vigamox) and topical steroid (Prednisolone Acetate Ophthalmic Suspension, Pred Forte)

Primary outcomes

  1. Visual acuity

    Time frame: 6 months

    Uncorrected and corrected distance visual acuity

Secondary outcomes

  1. Corneal measurements: pachymetry

    Time frame: 6 months

    Evaluation of the pachymetric maps with a Scheimpflug-Placido device (Sirius). Measurement in microns

  2. 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)

  3. 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

  4. Corneal measurements: keratometries.

    Time frame: 6 months

    Evaluation of the keratometric map with a Scheimpflug-Placido device (Sirius). Measurement in diopters

Sponsors and collaborators

Lead sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Other

Registry information

Official study title

Treatment of Keratoconus With Pachymetry Assisted Laser Keratoplasty (PALK) Versus Penetrating Keratoplasty (PK)

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Dec 9, 2015
Registry last updated
Dec 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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