Overview

Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking in Eyes With Keratoconus.

Status:
Terminated
Trial end date:
2016-04-01
Target enrollment:
0
Participant gender:
All
Summary
This study is being conducted to assess the safety and effectiveness of photochemically induced collagen cross- linking (CCL) at irradiance of 18mW/cm2 in eyes with Keratoconus and Ecstasia.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Nvision Laser Eye Centers
Treatments:
Riboflavin
Criteria
INCLUSION CRITERIA GENERAL:

1. 12 years of age or older

2. Signed written informed consent

3. Willingness and ability to comply with schedule for follow-up visits

4. Contact lens removal prior to evaluation and treatment

5. Candidates must also have two of the following criteria:

1. Presence of central or inferior steepening on the Pentacam or Orbscan map
consistent with Keratoconus.

2. Axial topography consistent with keratoconus.

3. Steepest keratometry (Kmax) value of 47.00D

INCLUSION CRITERIA FOR ECTASIA:

History of having undergone a keratorefractive procedure and 2 of the following criteria:

1. Steepening by topography, either Pentacam or Orbscan

2. Thinning of cornea

3. Shift in the position of thinnest portion of cornea

4. Change in refraction with increasing myopia

5. Development of myopic astigmatism

6. Development of irregular astigmatism

7. Loss of BSCVA

EXCLUSION CRITERIA:

I. Eyes classified as either normal or atypical normal 2. Corneal pachymetry 350
microns at the thinnest point measured by Pentacam in the eye to be treated 3. A
history of chemical injury or delayed epithelial healing in the eye to be treated.

4. Pregnancy (including plan to become pregnant) or lactation during the course of the
study 5. A known sensitivity to study medications 6. Patients with nystagmus or any
other condition that would prevent a steady gaze during the treatment 7. Inability to
cooperate with diagnostic tests. 8. Patients with a concomitant condition that, in the
investigator's opinion, would interfere with or prolong epithelial healing.

9. Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking
treatment.

10. Patients who are unable to remain supine and tolerate a lid speculum for an
extended period of time.

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