Trial Details

Multi-Center, Randomized, Controlled Evaluation of the Safety & Efficacy of the KXL System With VibeX (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in Eyes With Keratoconus or Corneal Ectasia After Refractive Surgery

NCT01459679

TERMINATED

DESCRIPTION

The objectives of this study are to evaluate and compare the safety and efficacy of three treatment regimens for corneal collagen cross-linking performed with VibeX (riboflavin ophthalmic solution) and the KXL System in impeding the progression of, and/or reducing maximum corneal curvature.

CONDITIONS

ELIGIBILITY CRITERIA

• Inclusion Criteria
• (all subjects): 1. Be at least 12 years of age, male or female, of any race; 2. Provide written informed consent and sign a HIPAA form. Patients who are under the age of 18 will need to sign an assent form as well as having a parent or legal guardian sign an informed consent; 3. Willingness and ability to follow all instructions and comply with schedule for follow-up visits; 4. For females capable of becoming pregnant, agree to have urine pregnancy testing performed prior to randomization of the study eye and on the day of the fellow eye treatment (which occurs between the 3 to 6 month study eye visits); must not be lactating, and must agree to use a medically acceptable form of birth control for at least one week prior to the randomization visit and continue to use the method until one month after the last dose of test article. 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); 5. BSCVA of ≥1 letter and ≤80 letters on ETDRS chart; 6. Presence of central or inferior steepening on the topographic map; 7. Contact Lens Wearers Only: Removal of contact lenses is required for a 1 week period prior to the screening visit(s); 8. Contact Lens Wearers Only: manifest refraction must be stable between two visits which occur at least 7 days apart. A stable refraction is one in which the manifest refraction spherical equivalent and the average K (Km) on the topographer taken at the first visit do not differ by more than 0.75 D from the respective measurements taken at the second exam;
• Mild Keratoconus 1. Axial topography consistent with keratoconus 2. Flat keratometry reading ≤ 51.00 D on topography map
• Moderate Keratoconus 1. Axial topography consistent with keratoconus 2. Flat keratometry reading ≥ 51.01 D and ≤ 56.00 D or astigmatism ≥ 8.00D on topography map
• Severe Keratoconus: 1. Axial topography consistent with keratoconus with marked areas of steepening 2. Flat keratometry reading ≥ 56.01 D on topography map
• Inclusion Criteria
• (corneal ectasia subjects only): 11. Having a diagnosis of corneal ectasia after refractive surgery; 12. Having axial topography consistent with ectasia;