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

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.