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Safety & Efficacy of Corneal Collagen Cross-Linking in Eyes With Keratoconus or Corneal Ectasia After Refractive Surgery

NCT01459679 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1721

Last updated 2018-07-05

No results posted yet for this study

Summary

The objectives of this study are to evaluate and compare the safety and efficacy of three treatment regimens for corneal collagen cross-linking performed with VibeX (riboflavin ophthalmic solution) and the KXL System in impeding the progression of, and/or reducing maximum corneal curvature.

Conditions

  • Keratoconus
  • Corneal Ectasia

Interventions

DEVICE

KXL System (15 mW/cm2)

UVA irradiation for 8 minutes at 15 mW/cm2

DEVICE

KXL System (30 mW/cm2)

UVA irradiation for 4 minutes at 30 mW/cm2

DEVICE

KXL System (45 mW/cm2)

UVA irradiation for 2 minutes 40 seconds at 45 mW/cm2

DRUG

riboflavin ophthalmic solution

Drops of riboflavin ophthalmic solution will be applied in the eye every two minutes for 20 minutes

Sponsors & Collaborators

  • American-European Congress of Ophthalmic Surgery

    lead NETWORK

Principal Investigators

  • John Vukich, MD · American-European Congress of Ophthalmic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2016-01-31
Completion
2016-08-31
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01459679 on ClinicalTrials.gov