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Treatment of Keratoconus With PALK Versus PK

NCT ID: NCT02625467

Last Updated: 2015-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-11-30

Brief Summary

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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

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Conditions

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Keratoconus

Keywords

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Keratoconus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Penetrating keratoplasty

Conventional penetrating keratoplasty technique

Group Type EXPERIMENTAL

Penetrating keratoplasty

Intervention Type PROCEDURE

Conventional Penetrating keratoplasty technique

Treatment posterior to surgery

Intervention Type DRUG

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

PALK

Pachymetry and Excimer laser assisted lamellar keratoplasty

Group Type EXPERIMENTAL

Pachymetry and Excimer laser assisted lamellar keratoplasty

Intervention Type PROCEDURE

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

Treatment posterior to surgery

Intervention Type DRUG

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

Interventions

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Penetrating keratoplasty

Conventional Penetrating keratoplasty technique

Intervention Type PROCEDURE

Pachymetry and Excimer laser assisted lamellar keratoplasty

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

Intervention Type PROCEDURE

Treatment posterior to surgery

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Oftalmología Fundación Conde de Valenciana

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Enrique Graue Hernandez, MD, MsC

Role: STUDY_DIRECTOR

Instituto de Oftalmologia Conde de Valenciana

Other Identifiers

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PALK vs PK

Identifier Type: -

Identifier Source: org_study_id