UVA-Riboflavin Crosslinking Treatment of Corneal Ectasia
1 other identifier
interventional
250
1 country
1
Brief Summary
The primary objective of this study is to evaluate two different ultraviolet (UV) dosing regimens for corneal collagen cross linking to slow the progressive changes in corneal curvature in eyes with progressive keratoconus or post-refractive surgery 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 Mar 2011
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 28, 2011
CompletedFirst Posted
Study publicly available on registry
March 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedMarch 29, 2011
March 1, 2011
3 years
March 28, 2011
March 28, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in corneal curvature
Measured by maximum keratometry (Kmax)
6 months
Secondary Outcomes (3)
corrected distance acuity
6 months
corneal endothelial cell count
6 months
pachymetry
6 months
Study Arms (2)
20 Minute UV-X Light Treatment Duration
ACTIVE COMPARATOR20 Minute UV-X Light Treatment Duration Note: "UV-X" is the trademark of Peschke GmbH
30 Minute UV-X Light Treatment Duration
ACTIVE COMPARATOR30 Minute UV-X Light Treatment Duration
Interventions
UV-X 365 nm wavelength light source is applied to the cornea with continued application of riboflavin 0.1%
Riboflavin 0.1% is applied to the cornea every 2 minutes for 14 minutes prior to and also during UV-X Light treatment.
Eligibility Criteria
You may qualify if:
- i. Age 14 years or older for keratoconus subjects since disease often begins at puberty, and 18 years or older for post-refractive surgery keratectasia and post-transplant patients
- ii. Signed, dated, written informed consent
- iii. 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 24 months or less before randomization:
- An increase of at least 1.0 diopter in the steepest keratometry value (or sim K), or
- an increase of at least 1.0 diopter in regular astigmatism evaluated by subjective manifest refraction, or
- a myopic shift (decrease in the spherical equivalent) of at least 0.5 diopters on subjective refraction, or
- documented decrease in visual acuity associated with irregular astigmatism and topographic features of ectasia
- iv. Have minimal preoperative corneal thickness of 375 microns or more, as measured in the office with epithelium not yet removed
- v. For subjects with non-post refractive surgery keratoconus diagnosis only:
- years or older to 55 years of age,
- axial topography consistent with keratoconus such as presence of abnormal central or paracentral steepening on the corneal topography map, or presence of one or more slit lamp findings associated with keratoconus, such as
- Fleischer ring
- Vogt striae
- Corneal thinning
- Corneal scarring
- +7 more criteria
You may not qualify if:
- i. Patients with excessively thin corneas. (Intraoperative minimal corneal thickness in the swollen state with the epithelium removed must exceed 400 microns)
- ii. Keratometric readings greater than 62D
- iii. No evidence of keratoconus/keratectasia progression over the prior three years
- iv. Age less than 55 years but under
- years for keratoconus patients
- years for post-refractive surgery keratectasia and post-transplant patients
- v. Previous ocular condition in the eye(s) to be treated that might, in the investigator's opinion, predispose to complications (such as history herpes simplex keratitis, corneal melt, perforated corneal ulcer, descemetocele, prior corneal damage from chemical injury, herpes zoster keratitis, nystagmus, corneal scarring that significantly impairs vision, pre-existing glaucoma, glaucoma suspect, Goldmann applanation pressure exceeding 23 mm Hg, cataract, history of uveitis, active ocular disease that might lead to infection, corneal endothelial cell count below 1800 cells per square millimeter)
- vi. Patients with a systemic condition that, in the investigator's opinion, might predispose to complications (such as Down syndrome, autoimmune disease, pregnancy or nursing at the time of initial treatment, history of alcohol abuse, being immunocompromised, allergy to riboflavin or other study medications)
- vii. Patients who are unwilling or unable to comply with the study regimen and doctor's advice
- viii. Patients unwilling to discontinue wear of rigid contact lenses in the eye to be operated on for at least one month before baseline examination, and for the first six months post-operatively
- ix. Patient unwilling to discontinue contact lenses prior to baseline exam: one week for soft lenses, two weeks for rigid or soft toric lenses
- x. Pregnancy at the time of proposed crosslinking
- xi. Known hypersensitivity to riboflavin
- xii. Central corneal endothelial cell count below 1400 cells per square millimeter.
- xiii. Presence of significant central corneal stromal scar
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mercy Center for Corrective Eye Surgery
McHenry, Illinois, 60050, United States
Related Publications (6)
Caporossi A, Mazzotta C, Baiocchi S, Caporossi T. Long-term results of riboflavin ultraviolet a corneal collagen cross-linking for keratoconus in Italy: the Siena eye cross study. Am J Ophthalmol. 2010 Apr;149(4):585-93. doi: 10.1016/j.ajo.2009.10.021. Epub 2010 Feb 6.
PMID: 20138607RESULTGoldich Y, Marcovich AL, Barkana Y, Avni I, Zadok D. Safety of corneal collagen cross-linking with UV-A and riboflavin in progressive keratoconus. Cornea. 2010 Apr;29(4):409-11. doi: 10.1097/ICO.0b013e3181bd9f8c.
PMID: 20164744RESULTWittig-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: 18811118RESULTRaiskup-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: 18471635RESULTMazzotta 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: 16952090RESULTCaporossi 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: 16765803RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert L Epstein, MD
Mercy Center for Corrective Eye Surgery
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 28, 2011
First Posted
March 29, 2011
Study Start
March 1, 2011
Primary Completion
March 1, 2014
Study Completion
May 1, 2014
Last Updated
March 29, 2011
Record last verified: 2011-03