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Corneal Crosslinking in Patients With Keratoconus and Post-Refractive Ectasia

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ClinicalTrials.gov Identifier: NCT01143389
Recruitment Status : Completed
First Posted : June 14, 2010
Results First Posted : May 4, 2018
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Price Vision Group

Brief Summary:
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 or disease Intervention/treatment Phase
Keratoconus Post-Refractive Ectasia Drug: Riboflavin Device: UVX light Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Two Riboflavin Dosing Regimens for Corneal Collagen Cross-Linking in Eyes With Progressive Keratoconus or Ectasia
Study Start Date : May 2010
Actual Primary Completion Date : May 30, 2017
Actual Study Completion Date : August 30, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Riboflavin
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Riboflavin 0.1% eyedrops every 5 minutes
The eye will be irradiated for 30 minutes with UVX light, during which time instillation of riboflavin will continue (1 drop every 5 minutes for this arm).
Drug: Riboflavin
Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.
Device: UVX light
UVX 365 nm wavelength light source is applied with continued application of riboflavin.
Active Comparator: Riboflavin 0.1% eyedrops every 2 minutes
The eye will be irradiated for 30 minutes with UVX light, during which time instillation of riboflavin will continue (1 drop every 2 minutes for this arm).
Drug: Riboflavin
Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.
Device: UVX light
UVX 365 nm wavelength light source is applied with continued application of riboflavin.



Primary Outcome Measures :
  1. Change in Maximum Keratometry From Baseline to 6 Months After Treatment [ Time Frame: 6 months ]
    Change in maximum keratometry (Kmax) between baseline and 6 months after treatment, measured by corneal tomography.


Secondary Outcome Measures :
  1. Pachymetry [ Time Frame: 6 months ]
    Minimum corneal thickness measured by corneal tomography

  2. Corrected Distance Visual Acuity (CDVA) [ Time Frame: 6 months ]
    Corrected distance visual acuity (CDVA) reported in logarithm of the minimum angle of resolution (logMAR)

  3. Uncorrected Distance Visual Acuity (UDVA) [ Time Frame: 6 months ]
    Uncorrected distance visual acuity reported in logarithm of the minimum angle of resolution units



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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01143389


Locations
United States, Indiana
Price Vision Group
Indianapolis, Indiana, United States, 46260
Sponsors and Collaborators
Price Vision Group
Investigators
Principal Investigator: Francis W Price, MD Price Vision Group
  Study Documents (Full-Text)

Documents provided by Price Vision Group:
Study Protocol  [PDF] September 16, 2016
Statistical Analysis Plan  [PDF] September 12, 2017


Additional Information:
Publications:
Responsible Party: Price Vision Group
ClinicalTrials.gov Identifier: NCT01143389     History of Changes
Other Study ID Numbers: 2010-0243
First Posted: June 14, 2010    Key Record Dates
Results First Posted: May 4, 2018
Last Update Posted: May 4, 2018
Last Verified: April 2018

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

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