Corneal Crosslinking in Patients With Keratoconus and Post-Refractive Ectasia

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Price Vision Group
Sponsor:
Information provided by (Responsible Party):
Price Vision Group
ClinicalTrials.gov Identifier:
NCT01143389
First received: June 11, 2010
Last updated: August 21, 2014
Last verified: August 2014
  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

Resource links provided by NLM:


Further study details as provided by Price Vision Group:

Primary Outcome Measures:
  • Change in corneal curvature [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measured by maximum keratometry (Kmax)


Secondary Outcome Measures:
  • Pachymetry [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Corrected Distance Acuity (CDA) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Manifest Refraction [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 264
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%

Detailed Description:

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
Criteria

Inclusion Criteria:

  1. 10 years of age or older
  2. 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:

    1. An increase of ≥ 1.00 D in the steepest keratometry value (or sim K)
    2. An increase of ≥ 1.00 D in regular astigmatism evaluated by subjective manifest refraction
    3. A myopic shift (decrease in the spherical equivalent) of ≥ 0.50 D on subjective manifest refraction
    4. Documented decrease in visual acuity associated with irregular astigmatism and topographic features of ectasia.
  3. 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

  4. 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

  5. Signed written informed consent

Exclusion Criteria:

  • 1. Any keratoconus patient over 21 years of age 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01143389

Contacts
Contact: Marianne Price, Ph.D. 317-814-2990 marianneprice@cornea.org
Contact: Clorissa Quillin 317-814-2996 clorissaquillin@cornea.org

Locations
United States, Indiana
Price Vision Group Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Marianne Price, Ph.D    317-814-2990    marianneprice@cornea.org   
Principal Investigator: Francis Price, MD         
Sponsors and Collaborators
Price Vision Group
Investigators
Principal Investigator: Francis W Price, MD Price Vision Group
  More Information

Additional Information:
Publications:
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: August 21, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Price Vision Group:
Keratoconus
Ectasia
cross linking
collagen cross linking

Additional relevant MeSH terms:
Riboflavin
Keratoconus
Dilatation, Pathologic
Corneal Diseases
Eye Diseases
Pathological Conditions, Anatomical
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on October 19, 2014