Recruiting NCT04787471
Corneal Crosslinking for Treatment of Corneal Neovascularization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 30 minute photoactivation of riboflavin 0.1%, 10 minute photoactivation of riboflavin 0.1%.
- Who it may be relevant to
- Registry conditions: Corneal Neovascularization. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized Comparison of Standard vs. Accelerated Corneal Crosslinking for Treatment of Corneal Neovascularization With or Without Concomitant Inflammation and/or Infection
Overview
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.
Interventions
- Combination product 30 minute photoactivation of riboflavin 0.1%
Use of riboflavin 0.1% eye drops and 3mW/cm2 UVA light for 30 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
Primary outcome measures
- corneal neovascularization as a proportion of the total corneal area [Time frame: 6 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Price Vision Group — Indianapolis
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. PMID 28655538
- 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. PMID 28495149
- 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. PMID 29203068
- 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. PMID 23062001
- 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. PMID 33395116
- 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. PMID 40172865
Identifiers
NCT: NCT04787471 · 2021-001