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| Name | Class |
|---|---|
| Cornea Research Foundation of America | OTHER |
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The study objective is to assess safety and efficacy of photo-activation of riboflavin for treatment of corneal neovascularization with or without concomitant inflammation and/or infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 30 minute photoactivation | Active Comparator | photoactivation of riboflavin 0.1% using 365-nm UV light, 3mW/cm2 for 30 minutes |
|
| 10 minute photoactivation | Active Comparator | photoactivation of riboflavin 0.1% using 365-nm UV light, 9mW/cm2 for 10 minutes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 30 minute photoactivation of riboflavin 0.1% | Combination Product | Use of riboflavin 0.1% eye drops and 3mW/cm2 UVA light for 30 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| corneal neovascularization as a proportion of the total corneal area | the cornea will be photographed and morphometric image analysis software will be used to measure corneal neovascularization as a proportion of the total corneal area. The proportion measured at baseline will be compared with the proportion measured at 6 months after treatment. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marianne Price, PhD | Contact | 317-814-2990 | mprice@cornea.org |
| Name | Affiliation | Role |
|---|---|---|
| Francis W Price, Jr., MD | Price Vision Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Price Vision Group | Recruiting | Indianapolis | Indiana | 46260 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28655538 | Background | Hersh PS, Stulting RD, Muller D, Durrie DS, Rajpal RK; U.S. Crosslinking Study Group. U.S. Multicenter Clinical Trial of Corneal Collagen Crosslinking for Treatment of Corneal Ectasia after Refractive Surgery. Ophthalmology. 2017 Oct;124(10):1475-1484. doi: 10.1016/j.ophtha.2017.05.036. Epub 2017 Jun 24. | |
| 28495149 | Background |
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| ID | Term |
|---|---|
| D016510 | Corneal Neovascularization |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
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| 10 minute photoactivation of riboflavin 0.1% | Combination Product | Use of riboflavin 0.1% eye drops and 9mW/cm2 UVA light for 10 minutes |
|
| Hersh PS, Stulting RD, Muller D, Durrie DS, Rajpal RK; United States Crosslinking Study Group. United States Multicenter Clinical Trial of Corneal Collagen Crosslinking for Keratoconus Treatment. Ophthalmology. 2017 Sep;124(9):1259-1270. doi: 10.1016/j.ophtha.2017.03.052. Epub 2017 May 7. |
| 29203068 | Background | Price MO, Fairchild K, Feng MT, Price FW Jr. Prospective Randomized Trial of Corneal Cross-linking Riboflavin Dosing Frequencies for Treatment of Keratoconus and Corneal Ectasia. Ophthalmology. 2018 Apr;125(4):505-511. doi: 10.1016/j.ophtha.2017.10.034. Epub 2017 Dec 2. |
| 23062001 | Background | Price MO, Tenkman LR, Schrier A, Fairchild KM, Trokel SL, Price FW Jr. Photoactivated riboflavin treatment of infectious keratitis using collagen cross-linking technology. J Refract Surg. 2012 Oct;28(10):706-13. doi: 10.3928/1081597X-20120921-06. |
| 33395116 | Background | Schaub F, Hou Y, Zhang W, Bock F, Hos D, Cursiefen C. Corneal Crosslinking to Regress Pathologic Corneal Neovascularization Before High-Risk Keratoplasty. Cornea. 2021 Feb 1;40(2):147-155. doi: 10.1097/ICO.0000000000002406. |
| 40172865 | Derived | Price FW Jr, Tefasse Z, Frances KD, Feng MT, Gang A, Price MO. Assessment of Corneal Crosslinking for the Treatment of Corneal Neovascularization With and Without Associated Infection. Cornea. 2026 Apr 1;45(4):450-456. doi: 10.1097/ICO.0000000000003869. Epub 2025 Apr 2. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |