Corneal Neovascularization Clinical Trial
Official title:
Randomized Comparison of Standard vs. Accelerated Corneal Crosslinking for Treatment of Corneal Neovascularization With or Without Concomitant Inflammation and/or Infection
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.
Status | Recruiting |
Enrollment | 62 |
Est. completion date | July 15, 2025 |
Est. primary completion date | April 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Price Vision Group | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Price Vision Group | Cornea Research Foundation of America |
United States,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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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