A Phase 2/3 interventional study of Riboflavin-5-phosphate and Sham cross-linking in Keratoconus, sponsored by University at Buffalo. Status unknown at 2 sites in United States. Open to participants aged 16 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-02-11.
Sponsored by University at Buffalo · Phase 2/3, Interventional, and Treatment
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.
307 studies on the registry are indexed under Keratoconus; 56 are open to participants now.
This study's planned enrollment of 150 is above the median of 40 across 203 interventional studies indexed under Keratoconus.
Browse Keratoconus studies →University at Buffalo is the lead sponsor of 73 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
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patients must meet the diagnostic criteria for keratoconus, which include one or more of the following features:
Exclusion Criteria:
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
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
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.
Also known as: Ricrolin (SOOFT Italia Inc.)
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.
Also known as: Goniosol
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
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
This study is status unknown, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.
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