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Currently, you can access the following clinical trials being conducted worldwide:

378040 studies
in
220 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Comparison of Standard vs. Accelerated Corneal Crosslinking

Clinicaltrials.gov identifier NCT03922542

Recruitment Status Recruiting

First Posted April 22, 2019

Last update posted March 4, 2021

Study Description

Brief summary:

The study objective is to compare accelerated and standard corneal crosslinking for treatment of progressive keratoconus or corneal ectasia.

  • Condition or Disease:Keratoconus
    Ectasia Corneal
  • Intervention/Treatment: Combination Product: riboflavin 0.1%
    Combination Product: Riboflavin 0.1%
  • Phase: Phase 2/Phase 3
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 510 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Randomized Comparison of Standard vs. Accelerated Corneal Crosslinking for Treatment of Progressive Keratoconus or Ectasia
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: April 2025
  • Estimated Study Completion Date: May 2025
Arms and interventions
Arm Intervention/treatment
Active Comparator: Accelerated
Treatment with 0.1% riboflavin eye drops and 9 mW/cm2 UVA light for 10 minutes
Combination Product: riboflavin 0.1%
Use of riboflavin 0.1% eye drops and 9 mW/cm2 UVA light for 10 minutes
Active Comparator: Standard
Treatment with 0.1% riboflavin eye drops and 3 mW/cm2 UVA light for 30 minutes
Combination Product: Riboflavin 0.1%
Use of riboflavin 0.1% eye drops and 3 mW/cm2 UVA light for 30 minutes
Outcome Measures
  • Primary Outcome Measures: 1. Change in maximum keratometry [ Time Frame: 6 months ]
    assessed by corneal tomography
  • Secondary Outcome Measures: 1. Change in corrected distance visual acuity [ Time Frame: 6 months ]
    assessed with Snellen chart
  • 2. Change in uncorrected distance visual acuity [ Time Frame: 6 months ]
    assessed with Snellen chart
Eligibility Criteria
  • Ages Eligible for Study: 10 Years and older (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

- Documented keratoconus or ectasia after refractive surgery

Exclusion Criteria:

- Insufficient corneal thickness

- Ocular condition that may predispose the eye to complications

- History of chemical injury or delayed epithelial healing

- Condition that would interfere with or prolong epithelial healing

- Known sensitivity to treatment medications

- Pregnancy

Contacts and Locations
Contacts

Contact: Marianne Price, PhD 317-814-2990 mprice@cornea.org

Locations

United States, Indiana
Price Vision Group
Indianapolis

Sponsors and Collaborators

Price Vision Group

Investigators

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

More Information