Microwave Treatment and Corneal Collagen Crosslinking for Keratoconus

NCT01672814 | Completed Phase 3

• 1 other identifier: VED-001
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Keratoconus; Collagen Crosslinking; Riboflavin; Microwave; Keraflex

Outcome Measures

Primary Outcomes (1)

• Maximum Keratometry

  The change in maximum keratometry (Kmax) from baseline will be evaluated at 12 months for all eyes randomized to the two treatment groups. As a secondary analysis of this endpoint,the change in maximum keratometry (Kmax)from baseline will be evaluated at 1,3 and 6 months for all eyes.

  12 months

Secondary Outcomes (1)

• Manifest refraction

  12 months

Other Outcomes (2)

• Visual Acuity

  12 months

• Endothelial cell density

  12 months

Study Arms (2)

Keraflex combined with Crosslinking

ACTIVE COMPARATOR

Vedera KXS microwave system used in conjunction with corneal collagen crosslinking performed with VibeX (Riboflavin ophthalmic solution)and the KXL UV System

Drug: riboflavin ophthalmic solution; Device: Vedera KXS Microwave System

Corneal collagen crosslinking alone

ACTIVE COMPARATOR

Corneal collagen crosslinking alone performed with VibeX (Riboflavin Ophthalmic Solution)and the KXL UV system

Drug: riboflavin ophthalmic solution

Interventions

riboflavin ophthalmic solution DRUG

Administration of riboflavin every 2 minutes for 20 minutes

Also known as: VibeX

Corneal collagen crosslinking alone; Keraflex combined with Crosslinking

Vedera KXS Microwave System DEVICE

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.

Also known as: Keraflex

Keraflex combined with Crosslinking

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be at least 18 years of age
• Provide written consent and sign a HIPAA form
• Willingness and ability to follow all instructions and comply with schedule for follow-up visits
• For females capable of becoming pregnant, agree to have urine pregnancy testing performed prior to treatment; must not be lactating, and must agree to use a medically acceptable form of birth control for at least one week prior to the treatment and continue to use the method until 1 month after the last dose of investigational product.
• Having topographic evidence of keratoconus which is graded as moderate or severe keratoconus
• Presence of central or inferior steepening on the Pentacam map
• Steepest keratometry (Kmax) value greater than or equal to 51.00D
• BSCVA of 80 letters or fewer for keratoconus on ETDRS chart
• Contact lens wearers only: remove contact lenses one week prior to the screening refraction
• Contact lens wearers only: manifest refraction must be stable between two visits that occur at least 7 days apart.

You may not qualify if:

• Contraindications, sensitivity or known allergy to the use of the test articles(S) or their components
• If female, be pregnant, nursing, or planning a pregnancy or have a positive urine pregnancy test at Visit 2 prior to treatment or during the course of the study
• Eyes classified as either normal,atypical normal,keratoconus suspect or mild keratoconus on the severity grading scheme
• A history of the insertion of INTACS in the eye to be treated
• A history of previous limbal relaxing incision procedure in the eye to be treated
• Corneal pachymetry that is \<350 microns at the thinnest point measured by Pentacam in the eye to be treated
• Eyes which are aphakic
• Eyes which are pseudophakic and do not have a UV blocking lens implanted
• Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications.
• A history of delayed epithelial healing in the eye to be treated
• Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests
• Patients with a current condition that, in the investigator's opinion,would interfere with or prolong epithelial healing
• Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment
• A history of previous corneal cross-linking treatment in the eye to be treated
• Have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study

Sponsors & Collaborators

• Cornea and Laser Eye Institute: lead

Study Sites (1)

Cornea and Laser Eye Institue - Hersh Vision Group

Teaneck, New Jersey, 07666, United States

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Peter S Hersh, MD

  Cornea and Laser Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2012
• First Posted: August 27, 2012
• Study Start: August 1, 2012
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 17, 2018

Record last verified: 2018-07

Locations

US (1)