Corneal Crosslinking for Treatment of Corneal Neovascularization

February 6, 2024 updated by: Price Vision Group

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

62

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Price Vision Group
        • Principal Investigator:
          • Francis Price, Jr., MD
        • Sub-Investigator:
          • Matthew Feng, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
corneal neovascularization as a proportion of the total corneal area
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Price Vision Group

Collaborators

Cornea Research Foundation of America

Investigators

  • Principal Investigator: Francis W Price, Jr., MD, Price Vision Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2021

Primary Completion (Estimated)

April 15, 2025

Study Completion (Estimated)

July 15, 2025

Study Registration Dates

First Submitted

March 3, 2021

First Submitted That Met QC Criteria

March 5, 2021

First Posted (Actual)

March 8, 2021

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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