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

Arm | Intervention/treatment |
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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.
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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.
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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 |
- 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 ]

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Ages Eligible for Study: | 16 Years to 35 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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
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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

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
Contact: James J. Reidy, M.D. | 716-881-7920 | jreidymd@mac.com | |
Contact: Jeanne Stutz | 716-881-7920 | jstutz@buffalo.edu |
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. |
Principal Investigator: | James J Reidy, M.D. | SUNY at Buffalo School of Medicine & Biomedical Sciences |
Publications of Results:
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 |
Cornea Keratoconus Ectasia Riboflavin Collagen cross-linking |
Keratoconus Corneal Diseases Eye Diseases Riboflavin Flavin Mononucleotide Vitamin B Complex |
Vitamins Micronutrients Physiological Effects of Drugs Photosensitizing Agents Dermatologic Agents |