ACOS-KXL-001 Corneal Collagen Cross-Linking in Eyes with

Keratoconus or Corneal Ectasia after Refractive Surgery

Patient Pre-Screening Script

Thank you for your interest in the corneal collagen cross-linking study for Keratoconus or Corneal Ectasia after refractive surgery.

  • Keratoconus is a condition in which the cornea (clear front part of the eye) thins and becomes cone-shaped causing visual problems.
  • Corneal Ectasia is a condition in which the cornea (clear front part of the eye) thins and becomes irregularly shaped causing visual problems after refractive surgery.

The purpose of this study is to evaluate the safety and effectiveness of the KXL System (ultraviolet light treatment) with riboflavin (vitamin B2) solution (eye drops) for the treatment of Keratoconus and Corneal Ectasia.

Participation in this study would last approximately 12 months and will require eight study visits to our office including a screening visit (to determine if you are eligible to participate), a treatment visit (Day 0), and follow-up visits at Day 1, 1 week, 1 month, 3 months, 6 months and 12 months.

In order to help determine if you might qualify to participate in this study, I need to ask you a few questions about your present condition. You do not have to answer any questions you do not want to answer. If you do not qualify for this study, with your permission, the information you provide may be used to see if you qualify for future studies, otherwise, the information you give me will be destroyed.

Do I have your permission to proceed? Yes/No

  1. Name:______
  1. Date of Birth:______(must be 12 years of age or older)
  1. Have you ever been diagnosed with Keratoconus? (If yes, continue to Question 4. If no, skip to Question 12)
  1. Date diagnosed with Keratoconus:______
  1. Eye diagnosed with Keratoconus: Right/ Left / Both Eyes
  1. Do you wear contact lenses?Yes / No
  2. If yes, Right/Left / Both Eyes?
  3. If yes, what type of contact lenses do you wear?
  4. Soft
  5. Soft extended wear
  6. Soft toric
  7. Rigid/hard gas permeable lenses
  8. Other (specify):______
  1. Are you willing and able to return for all study visits? Yes / No

(must be yes for subject to qualify)

  1. Have you ever had previous corneal surgery or the insertion of Intacs(corneal implants) in the eye to be treated? Yes / No (must be no for subject to qualify)
  1. Other than Keratoconus or needing to wear glasses or contact lenses, have you ever had any other eye disease or condition? Yes / No
  2. If yes, what is/was the diagnosis? ______
  3. Which eye? Right/ Left/ Both Eyes
  4. Date of Diagnosis? ______
  5. What did your doctor recommend for your eye disease or condition? ______
  1. Do you have a history of any corneal disease? Yes / No
  2. If yes, what is/was your diagnosis?______
  3. Which eye? Right / Left / Both Eyes
  4. Date of diagnosis?______
  5. What type of treatment did you receive? ______
  1. Are you pregnant/lactating or do you plan to become pregnant during the next 12 months? Yes / No(must be no for subject to qualify)

Do you have a known sensitivity to riboflavin (vitamin B2)? Yes / No

(must be no for subject to qualify)

If patient answered Keratoconus questions (4 through 11), skip questions 12 through 21 and continue with the rest of the script.

  1. Have you ever been diagnosed with corneal ectasia after you received refractive surgery (e.g. LASIK,PRK)? (If yes, continue to question 13. If patient has not been diagnosed with corneal ectasia or keratoconus, he/sheis not eligible for this study. Skip questions 13 through 21 and continue with the rest of the script).
  1. Date of Refractive Surgery (e.g., LASIK, PRK):Right Eye______

Left Eye______

  1. Date first diagnosed with Corneal Ectasia:______
  1. Eye diagnosed with Corneal Ectasia: Right / Left / Both Eyes
  1. Do you wear contact lenses? Yes / No
  2. If yes, Right / Left / Both Eyes?
  3. If yes, what type of contact lenses do you wear?
  4. Soft
  5. Soft extended wear
  6. Soft toric
  7. Rigid/hard gas permeable lenses
  8. Other (specify):______
  1. Are you willing and able to return for all study visits? Yes / No

(must be yes for subject to qualify)

  1. Have you ever had previous corneal surgery (other than for refractive correction) or the insertion of Intacs (corneal implants) in the eye to be treated? Yes / No (must be no for subject to qualify)
  2. Other than Corneal Ectasia or needing to wear glasses or contact lenses, have you ever had any other eye disease or condition? Yes / No
  3. If yes, what is/was the diagnosis? ______
  4. Which eye? Right / Left/ Both Eyes
  5. Date of Diagnosis? ______
  6. What did your doctor recommend for your eye disease or condition? ______
  1. Are you pregnant/lactating or do you plan to become pregnant during the next 12 months? Yes / No(must be no for subject to qualify)
  1. Do you have a known sensitivity to riboflavin (vitamin B2)? Yes / No

(must be no for subject to qualify)

Based on the information you’ve provided during this pre-screening call, it appears:

  • You are eligible to be screened and thereforewe would like to schedule ascreening visit to confirm your eligibility.
  • Can we schedulean appointment for your screening visit now? Yes / No
  • Date of scheduled screening visit.______
  • You are not eligible; however we would like to keep your information in our database for future studies that you may be eligible to participate in. If we keep your information, it will be stored in a secure database at our site.
  • Will you allow us to keep your information? Yes / No

Thank you for taking the time to complete this pre-screening interview. If you have any questions please feel free to contact the study physician or the study coordinator at [Site contact information].

Date: ______

Name: ______

Signature: ______

Page 1 of 3Version Date 24Apr12

Protocol ACOS KXL-001