Treatment of Keratoconus With PALK Versus PK

Keratoconus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02625467
• Other study ID #: PALK vs PK
• Status: Completed
• Phase: Phase 1
• First received: December 1, 2015
• Last updated: December 5, 2015
• Start date: June 2013
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Instituto de Oftalmología Fundación Conde de Valenciana
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: National Council of Science and Technology
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Keratoconus

Intervention

Procedure:
• Penetrating keratoplasty
Conventional Penetrating keratoplasty technique
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Oftalmología Fundación Conde de Valenciana

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual acuity	Uncorrected and corrected distance visual acuity	6 months	No
Secondary	Corneal measurements: pachymetry	Evaluation of the pachymetric maps with a Scheimpflug-Placido device (Sirius). Measurement in microns	6 months	No
Secondary	Corneal aberrometry: Coma, spherical aberration and trefoil	Evaluation of the corneal aberrations including coma, spherical aberration and trefoil, with a Scheimpflug-Placido device (Sirius)	6 months	No
Secondary	Corneal measurements: anterior and posterior elevation	Evaluation of the elevation (anterior and posterior), maps with a Scheimpflug-Placido device (Sirius). Measurement in diopters	6 months	No
Secondary	Corneal measurements: keratometries.	Evaluation of the keratometric map with a Scheimpflug-Placido device (Sirius). Measurement in diopters	6 months	No