Corneal Crosslinking for Treatment of Corneal Neovascularization
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 30 minute photoactivation photoactivation of riboflavin 0.1% using 365-nm UV light, 3mW/cm2 for 30 minutes |
Combination Product: 30 minute photoactivation of riboflavin 0.1%
Use of riboflavin 0.1% eye drops and 3mW/cm2 UVA light for 30 minutes
|
| Active Comparator: 10 minute photoactivation photoactivation of riboflavin 0.1% using 365-nm UV light, 9mW/cm2 for 10 minutes |
Combination Product: 10 minute photoactivation of riboflavin 0.1%
Use of riboflavin 0.1% eye drops and 9mW/cm2 UVA light for 10 minutes
|
Outcome Measures
Primary Outcome Measures
- corneal neovascularization as a proportion of the total corneal area [6 months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18 years of age or older
-
With active inflammation or infection causing vascularization and possibly melting of the cornea, or vessels extending into the cornea causing lipid deposition, or vascularization that could significantly increase the risk of rejection of a current or planned corneal transplant, or vessels that continue to extend into the cornea despite topical treatment with corticosteroids.
-
Signed written informed consent.
Exclusion Criteria:
-
Known sensitivity to treatment medications
-
Current condition that in the investigator's opinion could compromise safety or data integrity.
-
Pregnancy (including plan to become pregnant) or lactation during the course of the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Price Vision Group | Indianapolis | Indiana | United States | 46260 |
Sponsors and Collaborators
- Price Vision Group
- Cornea Research Foundation of America
Investigators
- Principal Investigator: Francis W Price, Jr., MD, Price Vision Group
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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. Erratum in: Ophthalmology. 2017 Dec;124(12 ):1878.
- 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.
- 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.
- 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.
- 2021-001