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Crosslinking Agent

Standard vs. Accelerated Corneal Crosslinking for Keratoconus

Phase 2 & 3

Recruiting

Led By Francis W Price, Jr., MD

Research Sponsored by Price Vision Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented keratoconus or ectasia after refractive surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial will compare two methods of corneal crosslinking, accelerated and standard, to see which is more effective in treating progressive keratoconus or corneal ectasia.

Who is the study for?

This trial is for people with progressive keratoconus or corneal ectasia after refractive surgery. It's not suitable for those with conditions affecting eye healing, a history of chemical injury or slow healing, known sensitivity to the medications used in the study, pregnant individuals, those with thin corneas, or other ocular conditions that could complicate treatment.Check my eligibility

What is being tested?

The trial aims to compare two methods of corneal crosslinking: accelerated and standard. Both use riboflavin (vitamin B2) drops but differ in how quickly UV light is applied to strengthen the cornea and halt progression of keratoconus or ectasia.See study design

What are the potential side effects?

Potential side effects may include discomfort during treatment, temporary vision changes like haziness, risk of infection due to eye surface disruption during procedure, and delayed recovery leading to prolonged blurry vision.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with keratoconus or had corneal thinning after eye surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in maximum keratometry

Secondary outcome measures

Change in corrected distance visual acuity

Change in uncorrected distance visual acuity

Trial Design

2Treatment groups

Active Control

Group I: AcceleratedActive Control1 Intervention

Treatment with 0.1% riboflavin eye drops and 9 mW/cm2 UVA light for 10 minutes

Group II: StandardActive Control1 Intervention

Treatment with 0.1% riboflavin eye drops and 3 mW/cm2 UVA light for 30 minutes

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Price Vision GroupLead Sponsor

11 Previous Clinical Trials

1,173 Total Patients Enrolled

1 Trials studying Keratoconus

510 Patients Enrolled for Keratoconus

Francis W Price, Jr., MDPrincipal InvestigatorPrice Vision Group

5 Previous Clinical Trials

2,938 Total Patients Enrolled

Media Library

Riboflavin 0.1% (Crosslinking Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03922542 — Phase 2 & 3

Keratoconus Research Study Groups: Accelerated, Standard

Keratoconus Clinical Trial 2023: Riboflavin 0.1% Highlights & Side Effects. Trial Name: NCT03922542 — Phase 2 & 3

Riboflavin 0.1% (Crosslinking Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03922542 — Phase 2 & 3

Keratoconus Patient Testimony for trial: Trial Name: NCT03922542 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we able to sign up for this experiment yet?

"That is correct, the clinical trial mentioned is looking for more participants and was last updated on 7/27/2022. The study requires 510 patients in total from 1 location."

Answered by AI

What types of medical conditions does Accelerated treatment usually address?

"dietary and nutritional therapies are often accelerated. This treatment is also effective for other conditions such as vitamin deficiency, joint pain, and supplementing vitamins."

Answered by AI

Is the Accelerated program unique or have other organizations done something similar?

"Right now, 20 different research trials are investigating Accelerated. Out of those 20, 11 are in the third stage. Most of the investigations for Accelerated take place in San Francisco; however, studies related to this topic are spread out over 47 locations."

Answered by AI

Who else is applying?

What state do they live in?

Missouri

What site did they apply to?

Price Vision Group

What portion of applicants met pre-screening criteria?

Met criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

I have progressive Keratoconus and received corneal cross linking in my left eye. Upon further testing I have been referred to treat my right eye. Expense is a concern. I want to help others with my condition to prevent further issues and prevent a corneal transplant in my future.

PatientReceived no prior treatments