Corneal Crosslinking in Patients With Keratoconus and Post-Refractive Ectasia
Evaluation of Two Riboflavin Dosing Regimens for Corneal Collagen Cross-Linking in Eyes With Progressive Keratoconus or Ectasia
1 other identifier
interventional
510
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2010
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 11, 2010
CompletedFirst Posted
Study publicly available on registry
June 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2017
CompletedResults Posted
Study results publicly available
May 4, 2018
CompletedJune 6, 2018
May 1, 2018
7.1 years
June 11, 2010
April 3, 2018
May 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Maximum Keratometry From Baseline to 6 Months After Treatment
Change in maximum keratometry (Kmax) between baseline and 6 months after treatment, measured by corneal tomography.
6 months
Secondary Outcomes (3)
Pachymetry
6 months
Corrected Distance Visual Acuity (CDVA)
6 months
Uncorrected Distance Visual Acuity (UDVA)
6 months
Study Arms (2)
Riboflavin 0.1% eyedrops every 5 minutes
ACTIVE COMPARATORThe 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).
Riboflavin 0.1% eyedrops every 2 minutes
ACTIVE COMPARATORThe 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).
Interventions
Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.
UVX 365 nm wavelength light source is applied with continued application of riboflavin.
Eligibility Criteria
You may qualify if:
- years of age or older
- 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:
- An increase of ≥ 1.00 D in the steepest keratometry value (or sim K)
- An increase of ≥ 1.00 D in regular astigmatism evaluated by subjective manifest refraction
- A myopic shift (decrease in the spherical equivalent) of ≥ 0.50 D on subjective manifest refraction
- Documented decrease in visual acuity associated with irregular astigmatism and topographic features of ectasia.
- 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
- Signed written informed consent
You may not qualify if:
- \. Any keratoconus patient over 21 years of age without evidence of progression of his corneal deformity.
- \. 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.
- \. 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.
- \. Pregnancy (including plan to become pregnant) or lactation during the course of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Price Vision Group
Indianapolis, Indiana, 46260, United States
Related Publications (5)
Wittig-Silva C, Whiting M, Lamoureux E, Lindsay RG, Sullivan LJ, Snibson GR. A randomized controlled trial of corneal collagen cross-linking in progressive keratoconus: preliminary results. J Refract Surg. 2008 Sep;24(7):S720-5. doi: 10.3928/1081597X-20080901-15.
PMID: 18811118BACKGROUNDRaiskup-Wolf F, Hoyer A, Spoerl E, Pillunat LE. Collagen crosslinking with riboflavin and ultraviolet-A light in keratoconus: long-term results. J Cataract Refract Surg. 2008 May;34(5):796-801. doi: 10.1016/j.jcrs.2007.12.039.
PMID: 18471635BACKGROUNDMazzotta C, Traversi C, Baiocchi S, Sergio P, Caporossi T, Caporossi A. Conservative treatment of keratoconus by riboflavin-uva-induced cross-linking of corneal collagen: qualitative investigation. Eur J Ophthalmol. 2006 Jul-Aug;16(4):530-5. doi: 10.1177/112067210601600405.
PMID: 16952090BACKGROUNDCaporossi A, Baiocchi S, Mazzotta C, Traversi C, Caporossi T. Parasurgical therapy for keratoconus by riboflavin-ultraviolet type A rays induced cross-linking of corneal collagen: preliminary refractive results in an Italian study. J Cataract Refract Surg. 2006 May;32(5):837-45. doi: 10.1016/j.jcrs.2006.01.091.
PMID: 16765803BACKGROUNDPrice MO, Fairchild K, Feng MT, Price FW Jr. Prospective Randomized Trial of Corneal Cross-linking Riboflavin Dosing Frequencies for Treatment of Keratoconus and Corneal Ectasia. Ophthalmology. 2018 Apr;125(4):505-511. doi: 10.1016/j.ophtha.2017.10.034. Epub 2017 Dec 2.
PMID: 29203068DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Limitations included the 6-month follow up duration and the reduced reproducibility of measurement techniques in eyes with ectasia as compared with normal eyes.
Results Point of Contact
- Title
- Marianne Price, PhD
- Organization
- Cornea Research Foundation of America
Study Officials
- PRINCIPAL INVESTIGATOR
Francis W Price, MD
Price Vision Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2010
First Posted
June 14, 2010
Study Start
May 1, 2010
Primary Completion
May 30, 2017
Study Completion
August 30, 2017
Last Updated
June 6, 2018
Results First Posted
May 4, 2018
Record last verified: 2018-05