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Treatment of Keratoconus Using Collagen Cross-Linking

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00841386
Recruitment Status : Unknown
Verified January 2009 by University at Buffalo.
Recruitment status was:  Recruiting
First Posted : February 11, 2009
Last Update Posted : February 11, 2009
Sponsor:
Information provided by:
University at Buffalo

Study Description
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Brief 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. .

Condition or disease Intervention/treatment Phase
Keratoconus Drug: Riboflavin-5-phosphate Drug: Sham cross-linking Phase 2 Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Keratoconus Using Collagen Cross-Linking By Means of Topical Riboflavin and UV Light.
Study Start Date : September 2008
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Best corrected visual acuity [ Time Frame: 24 months ]
  2. Spherical equivalent power of the cornea (Best spectacle refraction) [ Time Frame: 24 months ]
  3. KMax: the maximum corneal curvature [ Time Frame: 24 months ]
  4. Average corneal power of the cornea in the central 4 mm. [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Corneal resistance factor. [ Time Frame: 24 months ]
  2. Maximal posterior surface elevation of the cornea. [ Time Frame: 24 months ]
  3. Apical corneal thickness. [ Time Frame: 24 months ]
  4. Endothelial count. [ Time Frame: 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00841386


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

Locations
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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
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Principal Investigator: James J Reidy, M.D. SUNY at Buffalo School of Medicine & Biomedical Sciences
More Information
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Additional Information:

Publications of Results:

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Responsible Party: James J. Reidy, M.D., Department of Ophthalmology, SUNY at Buffalo
ClinicalTrials.gov Identifier: NCT00841386    
Other Study ID Numbers: 101365
First Posted: February 11, 2009    Key Record Dates
Last Update Posted: February 11, 2009
Last Verified: January 2009
Keywords provided by University at Buffalo:
Cornea
Keratoconus
Ectasia
Riboflavin
Collagen cross-linking
Additional relevant MeSH terms:
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Keratoconus
Corneal Diseases
Eye Diseases
Riboflavin
Flavin Mononucleotide
Vitamin B Complex
 Vitamins
Micronutrients
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents