Treatment of Keratoconus Using Collagen Cross-Linking

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by University at Buffalo.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University at Buffalo
ClinicalTrials.gov Identifier:
NCT00841386
First received: February 10, 2009
Last updated: NA
Last verified: January 2009
History: No changes posted
  Purpose

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. .


Condition Intervention Phase
Keratoconus
Drug: Riboflavin-5-phosphate
Drug: Sham cross-linking
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Keratoconus Using Collagen Cross-Linking By Means of Topical Riboflavin and UV Light.

Resource links provided by NLM:


Further study details as provided by University at Buffalo:

Primary Outcome Measures:
  • Best corrected visual acuity [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Spherical equivalent power of the cornea (Best spectacle refraction) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • KMax: the maximum corneal curvature [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Average corneal power of the cornea in the central 4 mm. [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Corneal resistance factor. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Maximal posterior surface elevation of the cornea. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Apical corneal thickness. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • Endothelial count. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: September 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cross-linking treatment
Topical anesthesia (lidocaine jelly 2%) will be used. The central 9 mm of corneal epithelium will be removed cautiously with an Amoils brush. Riboflavin 0.1% solution will be applied (10 mg riboflavin-5-phosphate in 10 ml dextran T-500 20% solution, supplied in a sterile, single dose container) to the cornea every 2-3 minutes for 15 minutes and then every 5 minutes thereafter. The UV source will be from the CBM VEGA X-linker (CSO, Florence, Italy). A wavelength of 370 nm will be used to direct 5.4 J/cm2 to the area of cornea debrided for 30 minutes. The distance from the UV source to the cornea will be 1.5 to 5.4 cm.
Drug: Riboflavin-5-phosphate
Riboflavin 0.1% (10 mg riboflavin-5-phosphate in 10 ml dextran T-500 20% solution, supplied in a sterile, single dose container) will be applied to the cornea every 2-3 minutes for 15 minutes prior to starting UV irradiation. The UV irradiation will be given in six 5 minute intervals. Additional riboflavin will be administered following each 5 minute UV treatment.
Other Name: Ricrolin (SOOFT Italia Inc.)
Sham Comparator: Sham treatment group
Topical anesthesia (lidocaine jelly 2%) will be used. Differing from the treatment group, no epithelium will be debrided, but instead, this step will be skipped and a 2% methylcellulose solution combined with 1% fluorescein dye will be applied to the cornea every 5 minutes for 30 minutes. The patient will be placed under the UV device, but instead of the UV light, the LED aiming beam will be applied for 30 minutes.
Drug: Sham cross-linking
Topical anesthesia (lidocaine jelly 2%) will be used. Differing from the treatment group, no epithelium will be debrided, but instead, this step will be skipped and 2% methylcellulose solution with 1% sodium fluorescein will be applied to the cornea every 5 minutes for 15 minutes, and then every 5 minutes during the sham UV treatment. The patient will be placed under the UV device, and the aiming beam applied.
Other Name: Goniosol

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

Ages Eligible for Study:   16 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841386

Contacts
Contact: James J. Reidy, M.D. 716-881-7920 jreidymd@mac.com
Contact: Jeanne Stutz 716-881-7920 jstutz@buffalo.edu

Locations
United States, New York
Fichte,Endl, & Elmer EyeCare Recruiting
Amherst, New York, United States, 14228
Contact: Linda Grant, C.O.M.T.    716-564-2020    linda.grant@fichte.com   
Contact: Michael Endl, M.D.    716-564-2020    mpderme@aol.com   
Principal Investigator: Michael Endl, M.D.         
Sub-Investigator: Thomas R Elmer, M.D.         
The Ira G. Ross Eye Institute Recruiting
Buffalo, New York, United States, 14209
Contact: James J Reidy, M.D.    716-881-7920    jreidymd@mac.com   
Principal Investigator: James J Reidy, M.D.         
Sub-Investigator: Sandra L Everett, M.D.         
Sponsors and Collaborators
University at Buffalo
Investigators
Principal Investigator: James J Reidy, M.D. SUNY at Buffalo School of Medicine & Biomedical Sciences
  More Information

Additional Information:
Publications:

Responsible Party: James J. Reidy, M.D., Department of Ophthalmology, SUNY at Buffalo
ClinicalTrials.gov Identifier: NCT00841386     History of Changes
Other Study ID Numbers: 101365
Study First Received: February 10, 2009
Last Updated: February 10, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by University at Buffalo:
Cornea
Keratoconus
Ectasia
Riboflavin
Collagen cross-linking

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases
Flavin Mononucleotide
Riboflavin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Photosensitizing Agents
Radiation-Sensitizing Agents
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014