Treatment of Keratoconus Using Collagen Cross-Linking
Information source: University at Buffalo
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Keratoconus
Intervention: Riboflavin-5-phosphate (Drug); Sham cross-linking (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: University at Buffalo Official(s) and/or principal investigator(s): James J Reidy, M.D., Principal Investigator, Affiliation: SUNY at Buffalo School of Medicine & Biomedical Sciences
Overall contact: James J. Reidy, M.D., Phone: 716-881-7920, Email: jreidymd@mac.com
Summary
The purpose of this study is to determine the effectiveness of collagen cross-linking in the
cornea in halting the progression and possibly partially reversing the effects of
keratoconus. Keratoconus is a progressive weakening in the cornea that causes irregular
astigmatism and thinning of the cornea. The overall effect is reduction of vision, and in
more advanced cases, scarring of the cornea that may lead to the need for corneal
transplantation. Cross-linking has been shown increase the rigidity of the cornea. The
patients would be treated once and then followed over 24 months. .
Clinical Details
Official title: Treatment of Keratoconus Using Collagen Cross-Linking By Means of Topical Riboflavin and UV Light.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Best corrected visual acuitySpherical equivalent power of the cornea (Best spectacle refraction) KMax: the maximum corneal curvature Average corneal power of the cornea in the central 4 mm.
Secondary outcome: Corneal resistance factor.Maximal posterior surface elevation of the cornea. Apical corneal thickness. Endothelial count.
Detailed description:
The goal is for two groups of approximately 66 patients to be included in the study. One
eye from the first group will undergo treatment, while the second group of age matched
individuals will serve as a control. It will be a prospective, randomized, blinded study.
Each patient will be randomized at the beginning of enrollment in the study and will receive
a randomization number. The following parameters will be followed: 1. Best corrected
spectacle acuity (BCSA) 2. The steepest keratometry measurement (KMax) as measured by
computerized corneal topography 3. Apical corneal thickness 4. Corneal mechanical
resistance. These measurements will be repeated at 1 month, 3 months, 6 months, 12, 18, and
24 months following treatment.
Eligibility
Minimum age: 16 Years.
Maximum age: 35 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- no prior history of ocular surgery
- treatment eye must have a maximum corneal power of between 47 D and 60 diopters
- corneal thickness must be greater than 400 µ
- absence of corneal scarring
- patients must meet the diagnostic criteria for keratoconus, which include one or more
of the following features:
- high myopia
- corneal ectasia as viewed by slit-lamp exam or measured by pachometry
- Vogt's striae
- topographic findings of superior flattening and inferior steepening of the
cornea
- presence of Fleischer ring
Exclusion Criteria:
- history of prior ocular surgery (history of contact lens use is not an exclusion
criterion)
- average corneal power > 60 D
- presence of corneal scarring
- corneal thickness 400 µ or less
- history of herpes simplex virus keratitis
- history of uveitis
- pre-existing glaucoma
Locations and Contacts
James J. Reidy, M.D., Phone: 716-881-7920, Email: jreidymd@mac.com
Fichte,Endl, & Elmer EyeCare, Amherst, New York 14228, United States; Recruiting Linda Grant, C.O.M.T., Phone: 716-564-2020, Email: linda.grant@fichte.com Michael Endl, M.D., Phone: 716-564-2020, Email: mpderme@aol.com Michael Endl, M.D., Principal Investigator Thomas R Elmer, M.D., Sub-Investigator
The Ira G. Ross Eye Institute, Buffalo, New York 14209, United States; Recruiting James J Reidy, M.D., Phone: 716-881-7920, Email: jreidymd@mac.com James J Reidy, M.D., Principal Investigator Sandra L Everett, M.D., Sub-Investigator
Additional Information
National Keratoconus Foundation
Starting date: September 2008
Last updated: February 10, 2009
|