Treatment of Keratoconus With PALK Versus PK

NCT02625467 | Completed Phase 1

• 1 other identifier: PALK vs PK
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Keratoconus

Keywords

Keratoconus

Outcome Measures

Primary Outcomes (1)

• Visual acuity

  Uncorrected and corrected distance visual acuity

  6 months

Secondary Outcomes (4)

• Corneal measurements: pachymetry

  6 months

• Corneal aberrometry: Coma, spherical aberration and trefoil

  6 months

• Corneal measurements: anterior and posterior elevation

  6 months

• Corneal measurements: keratometries.

  6 months

Study Arms (2)

Penetrating keratoplasty

EXPERIMENTAL

Conventional penetrating keratoplasty technique

Procedure: Penetrating keratoplasty; Drug: Treatment posterior to surgery

PALK

EXPERIMENTAL

Pachymetry and Excimer laser assisted lamellar keratoplasty

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

Interventions

Penetrating keratoplasty PROCEDURE

Conventional Penetrating keratoplasty technique

Penetrating keratoplasty

Pachymetry and Excimer laser assisted lamellar keratoplasty PROCEDURE

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

PALK

Treatment posterior to surgery DRUG

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

PALK; Penetrating keratoplasty

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Contraindication for any of the techniques evaluated.
• Requiring additional surgical procedures.
• Diagnostic of other ectasia that were not primary keratoconus.

Sponsors & Collaborators

• Instituto de Oftalmología Fundación Conde de Valenciana: lead

MeSH Terms

Conditions

Keratoconus

Interventions

Keratoplasty, Penetrating

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Corneal Transplantation; Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Transplantation

Study Officials

• Enrique Graue Hernandez, MD, MsC

  Instituto de Oftalmologia Conde de Valenciana

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2015
• First Posted: December 9, 2015
• Study Start: June 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: November 1, 2015
• Last Updated: December 9, 2015

Record last verified: 2015-12