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Safety and Efficacy of Corneal Collagen Cross-linking Following LASIK for Treatment of Hyperopia and Hyperopic Astigmatism

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01893359
Recruitment Status : Terminated
First Posted : July 9, 2013
Results First Posted : October 24, 2016
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Avedro, Inc.

Tracking Information
First Submitted Date  ICMJE June 28, 2013
First Posted Date  ICMJE July 9, 2013
Results First Submitted Date  ICMJE July 18, 2016
Results First Posted Date  ICMJE October 24, 2016
Last Update Posted Date June 15, 2018
Study Start Date  ICMJE August 2013
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2013)
  • MRSE Regression [ Time Frame: one week to six months ]
    The co-primary efficacy endpoints are a comparison of MRSE regression in the refractive outcome between the LASIK only eyes and the LASIK with cross-linking eyes within each treatment type and duration (2 minutes continuous UVA or 3 minutes pulsed UVA cross-linking) expressed as the change between one week and six months, and one week and twelve months.
  • MRSE Regression [ Time Frame: one week to twelve months ]
    The co-primary efficacy endpoints are a comparison of MRSE regression in the refractive outcome between the LASIK only eyes and the LASIK with cross-linking eyes within each treatment type and duration (2 minutes continuous UVA or 3 minutes pulsed UVA cross-linking) expressed as the change between one week and six months, and one week and twelve months.
Original Primary Outcome Measures  ICMJE
 (submitted: July 2, 2013)
  • MRSE Regression [ Time Frame: one week to six months ]
    The co-primary efficacy endpoints are a comparison of MRSE regression in the refractive outcome between the LASIK only eyes and the LASIK with cross-linking eyes within each treatment type and duration (2 minutes continuous UVA or 3 minutes pulsed UVA cross-linking) expressed as the change between one week and six months, and one week and twelve months.
  • MRSE Regression [ Time Frame: one week to twelve months ]
    The co-primary efficacy endpoints are a comparison of MRSE regression in the refractive outcome between the LASIK only eyes and the LASIK with cross-linking eyes within each treatment type and duration (2 minutes continuous UVA or 3 minutes pulsed UVA cross-linking) expressed as the change between one week and six months, and one week and twelve months
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Corneal Collagen Cross-linking Following LASIK for Treatment of Hyperopia and Hyperopic Astigmatism
Official Title  ICMJE A Multi-Center, Randomized, Controlled Evaluation of the Safety and Efficacy of LASIK With Cross-linking Performed With the KXL System and Photrexa ZD™ (Riboflavin Ophthalmic Solution) Compared to LASIK Alone for Hyperopia and Hyperopic Astigmatism
Brief Summary The objectives of this study are to evaluate the safety and efficacy, with regards to regression of refractive outcome, as measured by manifest refraction spherical equivalent (MRSE), of two treatment regimens for hyperopic and hyperopic astigmatic subjects: LASIK followed by cross-linking performed with the KXL System and Photrexa ZD™ (Riboflavin Ophthalmic Solution), as compared to LASIK alone.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Hyperopia
  • Hyperopic Astigmatism
Intervention  ICMJE
  • Drug: riboflavin ophthalmic solution, 0% dextran
    Other Name: Photrexa ZD
  • Device: UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)
    Other Name: KXL System
  • Device: UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)
    Other Name: KXL System
  • Procedure: Laser-assisted in situ keratomileusis
    Other Name: LASIK
Study Arms  ICMJE
  • Experimental: LASIK followed by Cross-linking (Continuous Wave)
    Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 2 minutes continuous UVA.
    Interventions:
    • Drug: riboflavin ophthalmic solution, 0% dextran
    • Device: UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)
    • Procedure: Laser-assisted in situ keratomileusis
  • Experimental: LASIK followed by Cross-linking (Pulsed)
    Following LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off.
    Interventions:
    • Drug: riboflavin ophthalmic solution, 0% dextran
    • Device: UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)
    • Procedure: Laser-assisted in situ keratomileusis
  • Placebo Comparator: LASIK Only
    Eyes assigned to this arm will receive standard LASIK with no cross-linking.
    Intervention: Procedure: Laser-assisted in situ keratomileusis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 31, 2016)
2
Original Estimated Enrollment  ICMJE
 (submitted: July 2, 2013)
110
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 1. Be at least 18 years of age, male or female, of any race;
  • 2. Provide written informed consent and sign a HIPAA form;
  • 3. Willingness and ability to follow all instructions and comply with the schedule for study visits;
  • 4. Undergoing bilateral LASIK for the correction of hyperopia or hyperopic astigmatism;
  • 5. Intended treatment > +2.0 diopters (D) to < +6.0 D of MRSE hyperopia or hyperopia with astigmatism, with up to +6.0 D of spherical component and up to 5.0 D of astigmatic component (all refractions measured at the spectacle plane);
  • 6. Bilateral physiologic hyperopia;
  • 7. For females capable of becoming pregnant, agree to have urine pregnancy testing performed at visit 2 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 visit 2 and continue to use the method for one month following the treatment. Acceptable forms for birth control are spermicide with barrier, oral contraceptive, injectable or implantable method of contraception, transdermal contraceptive, intrauterine device, or surgical sterilization of partner. For non-sexually active females, abstinence will be considered an acceptable form of birth control. Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (e.g. hysterectomy, bilateral tubal ligation, or bilateral oophorectomy);
  • 8. Best spectacle corrected visual acuity (BSCVA) of 70 letters or more on ETDRS chart;
  • 9. Difficulty maintaining uncorrected visual acuity (UCVA) of at least 70 letters on ETDRS chart as evidenced by need for constant contact lens or spectacle wear;
  • 10. Less than 0.75 D spherical equivalent difference between cycloplegic and manifest refractions;
  • 11. Stable refraction (a difference of 0.50 D or less in MRSE) for the last 12 months, objectively documented (by previous clinical records, prescriptions, etc.), exclusive of changes determined by the investigator to be due to unmasking latent hyperopia;
  • 12. Normal corneal topography, as judged by the investigator;
  • 13. Removal of contact lenses for the required period of time prior to the screening refraction:

    1. Soft - 3 Days
    2. Soft Toric - 2 Weeks
    3. Rigid gas permeable - 2 Weeks
  • 14. Contact Lens Wearers Only: Must demonstrate a stable refraction (a difference of 0.50 D or less) as determined by MRSE on two consecutive exam dates performed at least 7 days apart. A contact lens wearer is defined as someone who has worn contact lenses in either eye in the last 30 days.

Exclusion Criteria:

  • 1. Contraindications, sensitivity or known allergy to the use of the test article(s) or their components;
  • 2. 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;
  • 3. Eyes which are aphakic;
  • 4. Eyes which are pseudophakic and do not have a UV blocking lens implanted;
  • 5. Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study (e.g., dry eyes, immuno- compromised, connective tissue disease, clinically significant atopic disease, diabetes, etc.);
  • 6. Systemic medications that may confound the outcome of the study or increase the risk to the subject, including but not limited to steroids, antimetabolites, etc.;
  • 7. Ocular condition that may predispose the subject to future complications, for example:

    1. History or evidence of active or inactive corneal disease (e.g., herpes simplex keratitis, herpes zoster keratitis, recurrent corneal erosion syndrome, corneal dystrophy, etc.);
    2. Evidence of retinal vascular disease;
    3. Keratoconus or keratoconus suspect;
    4. Glaucoma or glaucoma suspect by exam findings and/or family history;
  • 8. Previous intraocular or corneal surgery including prior refractive surgery that might confound the outcome of the study or increase the risk to the subject;
  • 9. An increased risk for developing strabismus post-treatment;
  • 10. Subjects with nystagmus or any other condition that would prevent a steady gaze during treatment or other diagnostic tests;
  • 11. Taking supplements containing Vitamin C (ascorbic acid) within 1 week of the cross-linking treatment;
  • 12. Corneal thickness <470 microns as measured by Pentacam;
  • 13. The Investigator may exclude or discontinue any subject for any sound medical reason;
  • 14. The subject should not have participated in any investigational drug or device study within 30 days of screening or be concurrently enrolled in another investigational drug or device study.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01893359
Other Study ID Numbers  ICMJE KXL-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Avedro, Inc.
Study Sponsor  ICMJE Avedro, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Avedro, Inc.
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP