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Microwave Treatment and Corneal Collagen Crosslinking for Keratoconus

NCT01672814 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2018-07-17

No results posted yet for this study

Summary

This study compares the outcomes of the Vedera KXS procedure (a microwave-based procedure, also known as Keraflex) combined with corneal collagen crosslinking to corneal collagen crosslinking alone for the treatment of keratoconus. The goal is to improve corneal shape in patients with keratoconus.

Conditions

  • Keratoconus

Interventions

DRUG

riboflavin ophthalmic solution

Administration of riboflavin every 2 minutes for 20 minutes

DEVICE

Vedera KXS Microwave System

The Vedera KXS dose will be based on the pre-treatment manifest refraction spherical equivalent (MRSE), to be administered one day prior to the CXL procedure.

Sponsors & Collaborators

  • Cornea and Laser Eye Institute

    lead OTHER

Principal Investigators

  • Peter S Hersh, MD · Cornea and Laser Eye Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2017-06-01
Completion
2017-06-01

Countries

  • United States

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 NCT01672814 on ClinicalTrials.gov