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Corneal Collagen Cross-Linking (CXL) Performed With "Epi-ON" Versus "Epi-OFF" in Eyes With Keratoconus and Other Corneal Ectatic Disorders

Primary Purpose

Keratoconus, Ectasia

Status
Not yet recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ricrolin+
VEGA UV-A system
Sponsored by
Center for Sight, Sacramento, CA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Be at least 12 years of age or older, male or female, of any race.
  2. Having a diagnosis of keratoconus or other corneal ectatic disorder.
  3. Presence of central or inferior steepening on the topography map.
  4. Axial topography consistent with keratoconus or other corneal ectatic disorder.
  5. For eyes diagnosed with keratoconus, presence of one or more slit lamp findings associated with keratoconus, such as:

    1. Scissoring of the retinoscopic reflex
    2. Fleischer ring
    3. Vogt striae
    4. Corneal thinning e .Corneal scarring
  6. BSCVA 20/20 or worse.
  7. Subject is willing to have CXL performed by the Epi-OFF or Epi-ON techniques.
  8. Provide written informed consent and a signed HIPPA form. Pediatric subjects less than 14 years of age must sign an assent and a parent or legal guardian must sign an informed consent.
  9. Willingness and ability to follow all instructions and comply with schedule for follow-up visits.
  10. If female and capable of becoming pregnant, must not be lactating or pregnant and must agree to use a medically acceptable form of birth control for at least one week prior to the treatment visit and to continue o one month following treatment.

Exclusion Criteria:

  1. One of the randomized CXL techniques (Epi-OFF or Epi-ON) is contraindicated or, in the investigator's clinical judgment, is not able to be performed in the study eye.
  2. Study eye keratoconus severity is classified as being normal or atypical normal based on the OPD-Scan III keratoconus classification indices.
  3. A history of previous corneal transplant in the study eye.
  4. A history of prior CXL in the study eye.
  5. Corneal pachymetry < 375 microns at the thinnest point as measured by ultrasound pachymetry in the study eye before epithelium removal. [NOTE: Eyes with corneal pachymetry between <375 microns and 325 microns may be enrolled in the compassionate use group.]
  6. Presence of Intacs or corneal rings or segments in the study eye.
  7. Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications or prevent the possibility of improved vision, for example:

    1. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, or corneal dystrophy, etc.)
    2. Clinically significant corneal scarring in the treatment zone unrelated to keratoconus.
  8. Eyes which are aphakic.
  9. Eyes which are pseudophakic and do not have a UV blocking lens implanted.
  10. A known contraindication, sensitivity, or allergy to the test article or its components or to study medications.
  11. Nystagmus or any other condition that would prevent a steady gaze during the cross-linking treatment or other diagnostic tests.
  12. If female, pregnant, nursing or planning a pregnancy, or having a positive urine pregnancy test prior to the randomization of, or treatment of, either eye during the course of the study.
  13. A condition that, in the investigator's opinion, would interfere with or prolong epithelial healing, including a history of chemical injury or delayed epithelial healing in the study eye.
  14. Presence or history or any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for cross-linking or study participation or may confound the outcome of the study.

Sites / Locations

  • Center for Sight

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Epi-OFF CXL

Epi-ON CXL

Arm Description

The Epi-ON treatment will be performed without removal of the corneal epithelium. Ricrolin+will be used as the riboflavin formulation for the pre-treatment and irradiation steps of the Epi-ON treatments. The VEGA UV-A light will be used during the irradiation steps of the Epi-ON treatment.

The Epi-OFF treatment will be performed with removal of the corneal epithelium before the first dose of riboflavin is administered. Ricrolin+ will be used as the riboflavin formulation for the pre-treatment and irradiation steps of the Epi-OFF treatments. The VEGA UV-A light will be used during the irradiation steps of the Epi-OFF treatment.

Outcomes

Primary Outcome Measures

Mean change in corneal curvature
Percentage of eyes that had a greater than 2D increase in Kmax measured by the OPD-Scan III

Secondary Outcome Measures

Change in manifest refraction spherical equivalent
Change in refraction
Change in best-corrected visual acuity (BSCVA)
Percentage of eyes that had a loss of 2 or more lines in BSCVA
Change in uncorrected-visual acuity (UCVA)
Change in thinnest pachymetry
measured by ultrasound

Full Information

First Posted
February 26, 2019
Last Updated
February 26, 2019
Sponsor
Center for Sight, Sacramento, CA
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1. Study Identification

Unique Protocol Identification Number
NCT03858036
Brief Title
Corneal Collagen Cross-Linking (CXL) Performed With "Epi-ON" Versus "Epi-OFF" in Eyes With Keratoconus and Other Corneal Ectatic Disorders
Official Title
Comparison of Corneal Collagen Cross-Linking Performed With "Epi-ON" Versus "Epi-OFF" Techniques in Eyes With Keratoconus and Other Corneal Ectatic Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 8, 2019 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center for Sight, Sacramento, CA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a prospective, randomized, single investigative site study to compare the safety and effectiveness of Epi-OFF CXL treatment (performed using Ricrolin+ and VEGA UV-A system) compared to Epi-ON CXL (performed using Ricrolin+ and VEGA UV-A system) in eyes with keratoconus and other corneal ectatic disorders.Subjects will be randomized to receive the CXL treatment with either the Epi-On or Epi-Off technique.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
550 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epi-OFF CXL
Arm Type
Active Comparator
Arm Description
The Epi-ON treatment will be performed without removal of the corneal epithelium. Ricrolin+will be used as the riboflavin formulation for the pre-treatment and irradiation steps of the Epi-ON treatments. The VEGA UV-A light will be used during the irradiation steps of the Epi-ON treatment.
Arm Title
Epi-ON CXL
Arm Type
Active Comparator
Arm Description
The Epi-OFF treatment will be performed with removal of the corneal epithelium before the first dose of riboflavin is administered. Ricrolin+ will be used as the riboflavin formulation for the pre-treatment and irradiation steps of the Epi-OFF treatments. The VEGA UV-A light will be used during the irradiation steps of the Epi-OFF treatment.
Intervention Type
Drug
Intervention Name(s)
Ricrolin+
Intervention Description
1 to 2 drops of Ricrolin+ will be instilled topically in the eye every 2 minutes for 30 minutes. At the end of the Ricrolin+ pre-treatment period, the eye will be examined at the slit lamp to detect the presence of a yellow flare in the anterior chamber, indicating adequate riboflavin saturation of the corneal tissue. If the yellow flare is not detected, Ricrolin+ will continue to be instilled 1 drop every 2 minutes for an additional 5 to 10 minutes; and the anterior chamber will be rechecked for yellow flare. This process will be repeated as necessary. During the irradiation period, 1 to 2 drops of Ricrolin+ to cover the cornea (in the same manner as during the riboflavin pre-treatment) before the start of irradiation and every 5 minutes during irradiation until irradiation is complete.
Intervention Type
Device
Intervention Name(s)
VEGA UV-A system
Intervention Description
The VEGA light will be administered for 30 minutes. The VEGA light will stop automatically every 5 minutes for Ricrolin+ administration.
Primary Outcome Measure Information:
Title
Mean change in corneal curvature
Description
Percentage of eyes that had a greater than 2D increase in Kmax measured by the OPD-Scan III
Time Frame
Baseline, 6 Months, and 12 Months
Secondary Outcome Measure Information:
Title
Change in manifest refraction spherical equivalent
Description
Change in refraction
Time Frame
Baseline, 6 Months, and 12 Months
Title
Change in best-corrected visual acuity (BSCVA)
Description
Percentage of eyes that had a loss of 2 or more lines in BSCVA
Time Frame
Baseline, 6 Months, and 12 Months
Title
Change in uncorrected-visual acuity (UCVA)
Time Frame
Baseline, 6 Months, and 12 Months
Title
Change in thinnest pachymetry
Description
measured by ultrasound
Time Frame
Baseline, 6 Months, and 12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Be at least 12 years of age or older, male or female, of any race. Having a diagnosis of keratoconus or other corneal ectatic disorder. Presence of central or inferior steepening on the topography map. Axial topography consistent with keratoconus or other corneal ectatic disorder. For eyes diagnosed with keratoconus, presence of one or more slit lamp findings associated with keratoconus, such as: Scissoring of the retinoscopic reflex Fleischer ring Vogt striae Corneal thinning e .Corneal scarring BSCVA 20/20 or worse. Subject is willing to have CXL performed by the Epi-OFF or Epi-ON techniques. Provide written informed consent and a signed HIPPA form. Pediatric subjects less than 14 years of age must sign an assent and a parent or legal guardian must sign an informed consent. Willingness and ability to follow all instructions and comply with schedule for follow-up visits. If female and capable of becoming pregnant, must not be lactating or pregnant and must agree to use a medically acceptable form of birth control for at least one week prior to the treatment visit and to continue o one month following treatment. Exclusion Criteria: One of the randomized CXL techniques (Epi-OFF or Epi-ON) is contraindicated or, in the investigator's clinical judgment, is not able to be performed in the study eye. Study eye keratoconus severity is classified as being normal or atypical normal based on the OPD-Scan III keratoconus classification indices. A history of previous corneal transplant in the study eye. A history of prior CXL in the study eye. Corneal pachymetry < 375 microns at the thinnest point as measured by ultrasound pachymetry in the study eye before epithelium removal. [NOTE: Eyes with corneal pachymetry between <375 microns and 325 microns may be enrolled in the compassionate use group.] Presence of Intacs or corneal rings or segments in the study eye. Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications or prevent the possibility of improved vision, for example: History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, or corneal dystrophy, etc.) Clinically significant corneal scarring in the treatment zone unrelated to keratoconus. Eyes which are aphakic. Eyes which are pseudophakic and do not have a UV blocking lens implanted. A known contraindication, sensitivity, or allergy to the test article or its components or to study medications. Nystagmus or any other condition that would prevent a steady gaze during the cross-linking treatment or other diagnostic tests. If female, pregnant, nursing or planning a pregnancy, or having a positive urine pregnancy test prior to the randomization of, or treatment of, either eye during the course of the study. A condition that, in the investigator's opinion, would interfere with or prolong epithelial healing, including a history of chemical injury or delayed epithelial healing in the study eye. Presence or history or any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for cross-linking or study participation or may confound the outcome of the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jasmine Ly, OD
Phone
916-446-2020
Email
jly@liangvision.com
Facility Information:
Facility Name
Center for Sight
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jasmine Ly, OD
Phone
916-446-2020
Email
jly@liangvision.com
First Name & Middle Initial & Last Name & Degree
Keith Liang, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Corneal Collagen Cross-Linking (CXL) Performed With "Epi-ON" Versus "Epi-OFF" in Eyes With Keratoconus and Other Corneal Ectatic Disorders

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