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Comparison of Standard vs. Accelerated Corneal Crosslinking

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03922542
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : August 30, 2021
Sponsor:
Information provided by (Responsible Party):
Price Vision Group

Study Description
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Brief Summary:
The study objective is to compare accelerated and standard corneal crosslinking for treatment of progressive keratoconus or corneal ectasia.

Condition or disease Intervention/treatment Phase
Keratoconus Ectasia Corneal Combination Product: riboflavin 0.1% Combination Product: Riboflavin 0.1% Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
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 16, 2019
Estimated Primary Completion Date : April 1, 2026
Estimated Study Completion Date : May 1, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Riboflavin

Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922542


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

Locations
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United States, Indiana
Price Vision Group Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Marianne Price, Ph.D    317-814-2990    marianneprice@cornea.org   
Principal Investigator: Francis Price, MD         
Sponsors and Collaborators
Price Vision Group
Investigators
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Principal Investigator: Francis W Price, Jr., MD Price Vision Group
More Information
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Publications:

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Responsible Party: Price Vision Group
ClinicalTrials.gov Identifier: NCT03922542    
Other Study ID Numbers: 2019-003
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: August 30, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Keratoconus
Dilatation, Pathologic
Corneal Diseases
Eye Diseases
Pathological Conditions, Anatomical
Riboflavin
 Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents