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| Sponsor: | Price Vision Group |
|---|---|
| Information provided by (Responsible Party): | Price Vision Group |
| ClinicalTrials.gov Identifier: | NCT01143389 |
Purpose
The purpose of this study is to evaluate the effectiveness of using riboflavin and UV light to treat progressive keratoconus or post-refractive corneal ectasia.
| Condition | Intervention | Phase |
|---|---|---|
|
Keratoconus Post-Refractive Ectasia |
Device: UVX Light |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Evaluation of Two Riboflavin Dosing Regimens for Corneal Collagen Cross-Linking in Eyes With Progressive Keratoconus or Ectasia |
| Estimated Enrollment: | 200 |
| Study Start Date: | May 2010 |
| Estimated Primary Completion Date: | May 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Riboflavin 0.1% eyedrops every 5 minutes
The eye will be irradiated for 30 minutes, during which time instillation of riboflavin will continue (1 drop every 5 minutes for this arm).
|
Device: UVX Light
UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%
|
|
Active Comparator: Riboflavin 0.1% eyedrops every 2 minutes
The eye will be irradiated for 30 minutes, during which time instillation of riboflavin will continue (1 drop every 2 minutes for this arm).
|
Device: UVX Light
UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%
|
The primary objective of this study is to evaluate two riboflavin-dosing regimens for corneal collagen cross-linking to slow the progressive changes in corneal curvature in eyes with progressive keratoconus or post-refractive ectasia.
Eligibility| Ages Eligible for Study: | 10 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Having documented ectasia on topography or tomography after previous refractive surgery OR progressive keratoconus defined as one or more of the following changes over a period of 36 months or less before randomization:
Subjects with keratoconus diagnosis only:
a. Axial topography consistent with keratoconus b. Presence of central or inferior steepening on the Pentacam map. c. Presence of one or more slit lamp findings associated with keratoconus, such as: i. Fleischer ring ii. Vogt striae iii. Corneal thinning iv. Corneal scarring
Contact Lens Wearers Only: Removal of contact lenses for the required period of time prior to the screening refraction:
Contact Lens Type Minimum Discontinuation Time Soft 3 Days Soft Extended Wear 1 Week Soft Toric 2 Weeks Rigid gas permeable 2 Weeks
Exclusion Criteria:
1. Any keratoconus patient without evidence of progression of his corneal deformity.
2. Patients with excessively thin corneas. 3. Previous ocular condition in the eyes to be treated that may predispose the eye for future complications, for example:
a. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.) b. Clinically significant corneal scarring in the proposed treatment zone 4. A history of chemical injury or delayed epithelial healing in the eye(s) to be treated.
5. A known sensitivity to treatment medications. 6. Patients with a current condition that, in the treating physician's opinion, would interfere with or prolong epithelial healing.
7. Pregnancy (including plan to become pregnant) or lactation during the course of the study
Contacts and Locations| Contact: Marianne Price, Ph.D. | 317-814-2990 | marianneprice@cornea.org |
| Contact: Kelly Fairchild, BA | 317-814-2995 | kellyfairchild@cornea.org |
| United States, Indiana | |
| Price Vision Group | Recruiting |
| Indianapolis, Indiana, United States, 46260 | |
| Contact: Marianne Price, Ph.D 317-814-2990 marianneprice@cornea.org | |
| Contact: Kelly Fairchild, BA 317-814-2995 kellyfairchild@cornea.org | |
| Principal Investigator: Francis Price, MD | |
| Principal Investigator: | Francis W Price, MD | Price Vision Group |
More Information
| Responsible Party: | Price Vision Group |
| ClinicalTrials.gov Identifier: | NCT01143389 History of Changes |
| Other Study ID Numbers: | 2010-0243 |
| Study First Received: | June 11, 2010 |
| Last Updated: | April 13, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
|
Keratoconus Ectasia cross linking collagen cross linking |
|
Dilatation, Pathologic Keratoconus Pathological Conditions, Anatomical Corneal Diseases Eye Diseases Riboflavin Photosensitizing Agents Radiation-Sensitizing Agents |
Physiological Effects of Drugs Pharmacologic Actions Dermatologic Agents Therapeutic Uses Vitamin B Complex Vitamins Micronutrients Growth Substances |