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Treatment of Keratoconus Using Collagen Cross-Linking

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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

February 10, 2009
February 11, 2009
February 11, 2009
September 2008
December 2011   (Final data collection date for primary outcome measure)
  • Best corrected visual acuity [ Time Frame: 24 months ]
  • Spherical equivalent power of the cornea (Best spectacle refraction) [ Time Frame: 24 months ]
  • KMax: the maximum corneal curvature [ Time Frame: 24 months ]
  • Average corneal power of the cornea in the central 4 mm. [ Time Frame: 24 months ]
Same as current
No Changes Posted
  • Corneal resistance factor. [ Time Frame: 24 months ]
  • Maximal posterior surface elevation of the cornea. [ Time Frame: 24 months ]
  • Apical corneal thickness. [ Time Frame: 24 months ]
  • Endothelial count. [ Time Frame: 24 months ]
Same as current
Not Provided
Not Provided
 
Treatment of Keratoconus Using Collagen Cross-Linking
Treatment of Keratoconus Using Collagen Cross-Linking By Means of Topical Riboflavin and UV Light.
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. .
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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Keratoconus
  • 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.)
  • 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
  • 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.
    Intervention: Drug: Riboflavin-5-phosphate
  • 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.
    Intervention: Drug: Sham cross-linking

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
150
Same as current
December 2011
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
16 Years to 35 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00841386
101365
No
Not Provided
Not Provided
James J. Reidy, M.D., Department of Ophthalmology, SUNY at Buffalo
University at Buffalo
Not Provided
Principal Investigator: James J Reidy, M.D. SUNY at Buffalo School of Medicine & Biomedical Sciences
University at Buffalo
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP