Trial record 1 of 1 for:    NCT01672814
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Microwave Treatment and Corneal Collagen Crosslinking for Keratoconus

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Cornea and Laser Eye Institute
Sponsor:
Information provided by (Responsible Party):
Cornea and Laser Eye Institute
ClinicalTrials.gov Identifier:
NCT01672814
First received: August 22, 2012
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Keratoconus
Drug: riboflavin ophthalmic solution
Device: Vedera KXS Microwave System
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Controlled Study of the Vedera™ KXS Microwave System With Corneal Collagen Cross-Linking Compared With Corneal Collagen Cross-Linking Alone for Eyes With Keratoconus

Resource links provided by NLM:


Further study details as provided by Cornea and Laser Eye Institute:

Primary Outcome Measures:
  • Maximum Keratometry [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Manifest refraction [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The change in manifest refraction spherical equivalent from baseline will be evaluated at 12 months. As secondary analysis of this endpoint, a repeated measures analysis of variance will be conducted to assess the profile of the treatments across time at 1,3,and 6 months to look at the effect of wound healing on this variable.


Other Outcome Measures:
  • Visual Acuity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Change in BSCVA (best spectacle corrected visual acuity) and UCVA (uncorrected visual acuity) compared to the baseline examination will be evaluated at 12 months postoperatively. As a secondary analysis of this endpoint, data across time from 1,3, and 6 months following the procedure will be analyzed.

  • Endothelial cell density [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Endothelial cell count will be obtained using specular microscopy (Konan Medical) prior to KXS/CXL and CXL alone treatment and at 12 months postoperatively.


Estimated Enrollment: 130
Study Start Date: August 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Keraflex combined with Crosslinking
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
Administration of riboflavin every 2 minutes for 20 minutes
Other Name: VibeX
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.
Other Name: Keraflex
Active Comparator: Corneal collagen crosslinking alone
Corneal collagen crosslinking alone performed with VibeX (Riboflavin Ophthalmic Solution)and the KXL UV system
Drug: riboflavin ophthalmic solution
Administration of riboflavin every 2 minutes for 20 minutes
Other Name: VibeX

Detailed Description:

The objective of this study is to compare the safety and efficacy of the Vedera KXS (a microwave-based procedure) combined with corneal collagen cross-linking performed with VibeX (Riboflavin Ophthalmic Solution)and the KXL System to corneal collagen cross-linking alone in reducing corneal curvature in patients with keratoconus. Patients will be randomized into one of two treatment groups: Vedera KXS combined with corneal collagen cross-linking or collagen cross-linking alone. The Vedera KXS procedure performs a controlled application of microwave energy in an annular configuration. The goal of this procedure is to reshape the cornea to flatten the cornea and improve corneal topography in patients with keratoconus. The primary goal of collagen crosslinking is to stabilize the corneal shape in keratoconus and prevent progression of the disease. Moreover, investigations of crosslinking have shown the procedure not only to decrease keratoconus progression, but also to decrease the steepness of the cone and improve uncorrected and best corrected visual acuity in some cases. Since the mechanism of improvement differs between the procedures, this study will compare the combined microwave/crosslinking treatment to crosslinking alone.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672814

Locations
United States, New Jersey
Cornea and Laser Eye Institue - Hersh Vision Group Recruiting
Teaneck, New Jersey, United States, 07666
Contact: Bethann Furlong-Hibbert    201-883-0505    bfurlong-hibbert@vision-institute.com   
Contact: Stacey Lazar    201-883-0505    slazar@vision-institute.com   
Principal Investigator: Peter S Hersh, MD         
Sponsors and Collaborators
Cornea and Laser Eye Institute
Investigators
Principal Investigator: Peter S Hersh, MD Cornea and Laser Eye Institute
  More Information

No publications provided

Responsible Party: Cornea and Laser Eye Institute
ClinicalTrials.gov Identifier: NCT01672814     History of Changes
Other Study ID Numbers: VED-001
Study First Received: August 22, 2012
Last Updated: September 17, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Cornea and Laser Eye Institute:
Keratoconus
Collagen Crosslinking
Riboflavin
Microwave
Keraflex

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Riboflavin
Therapeutic Uses
Pharmacologic Actions
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on October 16, 2014