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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cross-linking treatment | Experimental | 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. |
|
| Sham treatment group | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Riboflavin-5-phosphate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Best corrected visual acuity | 24 months | |
| Spherical equivalent power of the cornea (Best spectacle refraction) | 24 months | |
| KMax: the maximum corneal curvature | 24 months | |
| Average corneal power of the cornea in the central 4 mm. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal resistance factor. | 24 months | |
| Maximal posterior surface elevation of the cornea. | 24 months | |
| Apical corneal thickness. |
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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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James J. Reidy, M.D. | Contact | 716-881-7920 | jreidymd@mac.com | |
| Jeanne Stutz | Contact | 716-881-7920 | jstutz@buffalo.edu |
| Name | Affiliation | Role |
|---|---|---|
| James J Reidy, M.D. | SUNY at Buffalo School of Medicine & Biomedical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fichte,Endl, & Elmer EyeCare | Recruiting | Amherst | New York | 14228 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17720054 | Result | Natarajan R, Padmanabhan P, Guruswami S. Hydration behavior of porcine cornea crosslinked with riboflavin and ultraviolet A. J Cataract Refract Surg. 2007 Sep;33(9):1503. doi: 10.1016/j.jcrs.2007.04.047. No abstract available. | |
| 17457184 | Result | Mazzotta C, Balestrazzi A, Traversi C, Baiocchi S, Caporossi T, Tommasi C, Caporossi A. Treatment of progressive keratoconus by riboflavin-UVA-induced cross-linking of corneal collagen: ultrastructural analysis by Heidelberg Retinal Tomograph II in vivo confocal microscopy in humans. Cornea. 2007 May;26(4):390-7. doi: 10.1097/ICO.0b013e318030df5a. |
| Label | URL |
|---|---|
| National Keratoconus Foundation | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 8, 2025 | |
| Reset | Aug 28, 2025 | |
| Release | May 12, 2026 | |
| Reset | Jun 5, 2026 | |
| Release | Jun 11, 2026 | |
| Reset | Jul 8, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 8, 2025 | Aug 28, 2025 | |||
| May 12, 2026 |
| ID | Term |
|---|---|
| D007640 | Keratoconus |
| D003316 | Corneal Diseases |
| D004108 | Dilatation, Pathologic |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D005486 | Flavin Mononucleotide |
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D012256 | Riboflavin |
| D005415 | Flavins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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|
|
| Sham cross-linking | Drug | 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. |
|
|
| 24 months |
| Endothelial count. | 24 months |
| The Ira G. Ross Eye Institute | Recruiting | Buffalo | New York | 14209 | United States |
|
| 17457183 | Result | Spoerl E, Mrochen M, Sliney D, Trokel S, Seiler T. Safety of UVA-riboflavin cross-linking of the cornea. Cornea. 2007 May;26(4):385-9. doi: 10.1097/ICO.0b013e3180334f78. |
| 16952090 | Result | Mazzotta C, Traversi C, Baiocchi S, Sergio P, Caporossi T, Caporossi A. Conservative treatment of keratoconus by riboflavin-uva-induced cross-linking of corneal collagen: qualitative investigation. Eur J Ophthalmol. 2006 Jul-Aug;16(4):530-5. doi: 10.1177/112067210601600405. |
| 16900027 | Result | Wollensak G. Crosslinking treatment of progressive keratoconus: new hope. Curr Opin Ophthalmol. 2006 Aug;17(4):356-60. doi: 10.1097/01.icu.0000233954.86723.25. |
| 16765803 | Result | Caporossi A, Baiocchi S, Mazzotta C, Traversi C, Caporossi T. Parasurgical therapy for keratoconus by riboflavin-ultraviolet type A rays induced cross-linking of corneal collagen: preliminary refractive results in an Italian study. J Cataract Refract Surg. 2006 May;32(5):837-45. doi: 10.1016/j.jcrs.2006.01.091. |
| 16565005 | Result | Kohlhaas M, Spoerl E, Schilde T, Unger G, Wittig C, Pillunat LE. Biomechanical evidence of the distribution of cross-links in corneas treated with riboflavin and ultraviolet A light. J Cataract Refract Surg. 2006 Feb;32(2):279-83. doi: 10.1016/j.jcrs.2005.12.092. |
| 12719068 | Result | Wollensak G, Spoerl E, Seiler T. Riboflavin/ultraviolet-a-induced collagen crosslinking for the treatment of keratoconus. Am J Ophthalmol. 2003 May;135(5):620-7. doi: 10.1016/s0002-9394(02)02220-1. |
| 17531694 | Result | Mencucci R, Mazzotta C, Rossi F, Ponchietti C, Pini R, Baiocchi S, Caporossi A, Menchini U. Riboflavin and ultraviolet A collagen crosslinking: in vivo thermographic analysis of the corneal surface. J Cataract Refract Surg. 2007 Jun;33(6):1005-8. doi: 10.1016/j.jcrs.2007.03.021. |
| Jun 5, 2026 |
| Jun 11, 2026 | Jul 8, 2026 |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D003067 | Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D012265 | Ribonucleotides |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D010860 | Pigments, Biological |
| D001685 | Biological Factors |
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |