Corneal Crosslinking for Treatment of Corneal Neovascularization

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-03

Study Completion Date

2026-09-15

Brief Summary

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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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Detailed Description

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Conditions

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Corneal Neovascularization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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30 minute photoactivation

photoactivation of riboflavin 0.1% using 365-nm UV light, 3mW/cm2 for 30 minutes

Group Type ACTIVE_COMPARATOR

30 minute photoactivation of riboflavin 0.1%

Intervention Type COMBINATION_PRODUCT

Use of riboflavin 0.1% eye drops and 3mW/cm2 UVA light for 30 minutes

10 minute photoactivation

photoactivation of riboflavin 0.1% using 365-nm UV light, 9mW/cm2 for 10 minutes

Group Type ACTIVE_COMPARATOR

10 minute photoactivation of riboflavin 0.1%

Intervention Type COMBINATION_PRODUCT

Use of riboflavin 0.1% eye drops and 9mW/cm2 UVA light for 10 minutes

Interventions

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30 minute photoactivation of riboflavin 0.1%

Use of riboflavin 0.1% eye drops and 3mW/cm2 UVA light for 30 minutes

Intervention Type COMBINATION_PRODUCT

10 minute photoactivation of riboflavin 0.1%

Use of riboflavin 0.1% eye drops and 9mW/cm2 UVA light for 10 minutes

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No