Treatment of Keratoconus Using Collagen Cross-Linking
Recruitment status was Recruiting
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. .
Drug: Sham cross-linking
|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.|
- 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 ]
- 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 ]
|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)|
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.
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841386
|Contact: James J. Reidy, M.D.||firstname.lastname@example.org|
|Contact: Jeanne Stutzemail@example.com|
|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 firstname.lastname@example.org|
|Contact: Michael Endl, M.D. 716-564-2020 email@example.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 firstname.lastname@example.org|
|Principal Investigator: James J Reidy, M.D.|
|Sub-Investigator: Sandra L Everett, M.D.|
|Principal Investigator:||James J Reidy, M.D.||SUNY at Buffalo School of Medicine & Biomedical Sciences|