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Microwave Treatment and Corneal Collagen Crosslinking for Keratoconus

Primary Purpose

Keratoconus

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

riboflavin ophthalmic solution

Vedera KXS Microwave System

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring Keratoconus, Collagen Crosslinking, Riboflavin, Microwave, Keraflex

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Cornea and Laser Eye Institue - Hersh Vision Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Keraflex combined with Crosslinking

Corneal collagen crosslinking alone

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Manifest refraction

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.

Full Information

NCT ID

NCT01672814

First Posted

August 22, 2012

Last Updated

July 16, 2018

Sponsor

Cornea and Laser Eye Institute

1. Study Identification

Unique Protocol Identification Number

NCT01672814

Brief Title

Microwave Treatment and Corneal Collagen Crosslinking for Keratoconus

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Completed

Study Start Date

August 2012 (undefined)

Primary Completion Date

June 1, 2017 (Actual)

Study Completion Date

June 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cornea and Laser Eye Institute

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Keratoconus

Keywords

Keratoconus, Collagen Crosslinking, Riboflavin, Microwave, Keraflex

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

3 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Keraflex combined with Crosslinking

Arm Type

Active Comparator

Arm Description

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

Arm Title

Corneal collagen crosslinking alone

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

riboflavin ophthalmic solution

Other Intervention Name(s)

VibeX

Intervention Description

Administration of riboflavin every 2 minutes for 20 minutes

Intervention Type

Device

Intervention Name(s)

Vedera KXS Microwave System

Other Intervention Name(s)

Keraflex

Intervention Description

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.

Primary Outcome Measure Information:

Title

Maximum Keratometry

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Manifest refraction

Description

Time Frame

12 months

Other Pre-specified Outcome Measures:

Title

Visual Acuity

Description

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.

Time Frame

12 months

Title

Endothelial cell density

Description

Endothelial cell count will be obtained using specular microscopy (Konan Medical) prior to KXS/CXL and CXL alone treatment and at 12 months postoperatively.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter S Hersh, MD

Organizational Affiliation

Cornea and Laser Eye Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cornea and Laser Eye Institue - Hersh Vision Group

City

Teaneck

State/Province

New Jersey

ZIP/Postal Code

07666

Country

United States

12. IPD Sharing Statement

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