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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 acuity

Spherical 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

Page last updated: August 20, 2015

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