Safety and Efficacy of Corneal Collagen Cross-linking Following LASIK for Treatment of Hyperopia and Hyperopic Astigmatism
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
1 other identifier
interventional
2
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2013
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2013
CompletedFirst Posted
Study publicly available on registry
July 9, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedResults Posted
Study results publicly available
October 24, 2016
CompletedApril 26, 2021
April 1, 2021
1.5 years
June 28, 2013
July 18, 2016
April 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
MRSE Regression
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.
one week to six months
MRSE Regression
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.
one week to twelve months
Study Arms (3)
LASIK followed by Cross-linking (Continuous Wave)
EXPERIMENTALFollowing 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.
LASIK followed by Cross-linking (Pulsed)
EXPERIMENTALFollowing 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.
LASIK Only
PLACEBO COMPARATOREyes assigned to this arm will receive standard LASIK with no cross-linking.
Interventions
Eligibility Criteria
You may qualify if:
- \. Be at least 18 years of age, male or female, of any race;
- \. Provide written informed consent and sign a HIPAA form;
- \. Willingness and ability to follow all instructions and comply with the schedule for study visits;
- \. Undergoing bilateral LASIK for the correction of hyperopia or hyperopic astigmatism;
- \. 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);
- \. Bilateral physiologic hyperopia;
- \. 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);
- \. Best spectacle corrected visual acuity (BSCVA) of 70 letters or more on ETDRS chart;
- \. 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;
- \. Less than 0.75 D spherical equivalent difference between cycloplegic and manifest refractions;
- \. 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;
- \. Normal corneal topography, as judged by the investigator;
- \. Removal of contact lenses for the required period of time prior to the screening refraction:
- Soft - 3 Days
- Soft Toric - 2 Weeks
- +2 more criteria
You may not qualify if:
- \. Contraindications, sensitivity or known allergy to the use of the test article(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 which are aphakic;
- \. Eyes which are pseudophakic and do not have a UV blocking lens implanted;
- \. 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.);
- \. 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.;
- \. Ocular condition that may predispose the subject to future complications, for example:
- History or evidence of active or inactive corneal disease (e.g., herpes simplex keratitis, herpes zoster keratitis, recurrent corneal erosion syndrome, corneal dystrophy, etc.);
- Evidence of retinal vascular disease;
- Keratoconus or keratoconus suspect;
- Glaucoma or glaucoma suspect by exam findings and/or family history;
- \. Previous intraocular or corneal surgery including prior refractive surgery that might confound the outcome of the study or increase the risk to the subject;
- \. An increased risk for developing strabismus post-treatment;
- \. Subjects with nystagmus or any other condition that would prevent a steady gaze during treatment or other diagnostic tests;
- \. Taking supplements containing Vitamin C (ascorbic acid) within 1 week of the cross-linking treatment;
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Gordon -Weiss-Schanzlin Vision Institute
San Diego, California, 92122, United States
Ophthalmic Consultants of Boston
Waltham, Massachusetts, 02451, United States
Hersh Vision Group
Teaneck, New Jersey, 07666, United States
Vance Thompson Vision
Sioux Falls, South Dakota, 57108, United States
See Clearly Vision
McLean, Virginia, 22102, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vineeta Belanger, VP of Clinical Affairs
- Organization
- Avedro, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2013
First Posted
July 9, 2013
Study Start
August 1, 2013
Primary Completion
February 1, 2015
Study Completion
April 1, 2016
Last Updated
April 26, 2021
Results First Posted
October 24, 2016
Record last verified: 2021-04