Treatment of Keratoconus With PALK Versus PK

December 5, 2015 updated by: Instituto de Oftalmología Fundación Conde de Valenciana

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity
Time Frame: 6 months
Uncorrected and corrected distance visual acuity
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corneal measurements: pachymetry
Time Frame: 6 months
Evaluation of the pachymetric maps with a Scheimpflug-Placido device (Sirius). Measurement in microns
6 months
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)
6 months
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
6 months
Corneal measurements: keratometries.
Time Frame: 6 months
Evaluation of the keratometric map with a Scheimpflug-Placido device (Sirius). Measurement in diopters
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Oftalmología Fundación Conde de Valenciana

Investigators

  • Study Director: Enrique Graue Hernandez, MD, MsC, INSTITUTO DE OFTALMOLOGIA CONDE DE VALENCIANA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

December 1, 2015

First Submitted That Met QC Criteria

December 5, 2015

First Posted (Estimate)

December 9, 2015

Study Record Updates

Last Update Posted (Estimate)

December 9, 2015

Last Update Submitted That Met QC Criteria

December 5, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PALK vs PK

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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