Treatment of Keratoconus With PALK Versus PK

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02625467

Enrollment

Registered

2015-12-09

Start date

2013-06-30

Completion date

2015-11-30

Last updated

2015-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus

Keywords

Keratoconus

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).

Interventions

PROCEDUREPenetrating keratoplasty

Conventional Penetrating keratoplasty technique

PROCEDUREPachymetry and Excimer laser assisted lamellar keratoplasty

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

DRUGTreatment posterior to surgery

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Visual acuity	6 months	Uncorrected and corrected distance visual acuity

Secondary

Measure	Time frame	Description
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
Corneal measurements: keratometries.	6 months	Evaluation of the keratometric map with a Scheimpflug-Placido device (Sirius). Measurement in diopters

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026