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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03858036
Recruitment Status : Not yet recruiting
First Posted : February 28, 2019
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Center for Sight, Sacramento, CA

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.

Condition or disease Intervention/treatment Phase
Keratoconus Ectasia Drug: Ricrolin+ Device: VEGA UV-A system Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 8, 2019
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024


Arm Intervention/treatment
Active Comparator: Epi-OFF CXL
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.
Drug: Ricrolin+
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.

Device: VEGA UV-A system
The VEGA light will be administered for 30 minutes. The VEGA light will stop automatically every 5 minutes for Ricrolin+ administration.

Active Comparator: Epi-ON CXL
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.
Drug: Ricrolin+
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.

Device: VEGA UV-A system
The VEGA light will be administered for 30 minutes. The VEGA light will stop automatically every 5 minutes for Ricrolin+ administration.




Primary Outcome Measures :
  1. Mean change in corneal curvature [ Time Frame: Baseline, 6 Months, and 12 Months ]
    Percentage of eyes that had a greater than 2D increase in Kmax measured by the OPD-Scan III


Secondary Outcome Measures :
  1. Change in manifest refraction spherical equivalent [ Time Frame: Baseline, 6 Months, and 12 Months ]
    Change in refraction

  2. Change in best-corrected visual acuity (BSCVA) [ Time Frame: Baseline, 6 Months, and 12 Months ]
    Percentage of eyes that had a loss of 2 or more lines in BSCVA

  3. Change in uncorrected-visual acuity (UCVA) [ Time Frame: Baseline, 6 Months, and 12 Months ]
  4. Change in thinnest pachymetry [ Time Frame: Baseline, 6 Months, and 12 Months ]
    measured by ultrasound



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858036


Contacts
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Contact: Jasmine Ly, OD 916-446-2020 jly@liangvision.com

Locations
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United States, California
Center for Sight
Sacramento, California, United States, 95816
Contact: Jasmine Ly, OD    916-446-2020    jly@liangvision.com   
Principal Investigator: Keith Liang, MD         
Sponsors and Collaborators
Center for Sight, Sacramento, CA
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Responsible Party: Center for Sight, Sacramento, CA
ClinicalTrials.gov Identifier: NCT03858036    
Other Study ID Numbers: CFS-CXL-001
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Keratoconus
Corneal Diseases
Eye Diseases