Treatment of Keratoconus With PALK Versus PK

Instituto de Oftalmología Fundación Conde de Valenciana

Status and phase: Completed; Phase 1

Conditions: Keratoconus

Treatments: Procedure: Penetrating keratoplasty; Drug: Treatment posterior to surgery; Procedure: Pachymetry and Excimer laser assisted lamellar keratoplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT02625467

PALK vs PK

Details and patient eligibility

About

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).

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Penetrating keratoplasty

Experimental group

Description:

Conventional penetrating keratoplasty technique

Treatment:

Procedure: Penetrating keratoplasty

Drug: Treatment posterior to surgery

PALK

Experimental group

Description:

Pachymetry and Excimer laser assisted lamellar keratoplasty

Treatment:

Drug: Treatment posterior to surgery

Procedure: Pachymetry and Excimer laser assisted lamellar keratoplasty