Treatment of Keratoconus With PALK Versus PK

Phase 1

Completed

• Conditions: Keratoconus
• Interventions: Procedure: Pachymetry and Excimer laser assisted lamellar keratoplasty; Procedure: Penetrating keratoplasty; Drug: Treatment posterior to surgery

• Registration Number: NCT02625467
• Lead Sponsor: Instituto de Oftalmología Fundación Conde de Valenciana

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2014-06
• Study Completion: 2015-11
• Status Verified: 2015-12
• Study First Submitted: 2015-12-01
• Study First Submitted QC: 2015-12-05
• Last Update Submitted: 2015-12-05
• Study First Posted: 2015-12-09
• Last Update Posted: 2015-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PALK	Treatment posterior to surgery	Pachymetry and Excimer laser assisted lamellar keratoplasty
Penetrating keratoplasty	Treatment posterior to surgery	Conventional penetrating keratoplasty technique
PALK	Pachymetry and Excimer laser assisted lamellar keratoplasty	Pachymetry and Excimer laser assisted lamellar keratoplasty
Penetrating keratoplasty	Penetrating keratoplasty	Conventional penetrating keratoplasty technique

Primary Outcome Measures

Name	Time	Method
Visual acuity	6 months	Uncorrected and corrected distance visual acuity

Secondary Outcome Measures

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