Comparison of Standard vs. Accelerated Corneal Crosslinking

Sponsor
Price Vision Group (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03922542
Collaborator
(none)
510
1
2
84.5
6

Study Details

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 Intervention/Treatment Phase
  • Combination Product: riboflavin 0.1%
  • Combination Product: Riboflavin 0.1%
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Apr 16, 2019
Anticipated Primary Completion Date :
May 1, 2026
Anticipated Study Completion Date :
May 1, 2026

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 [6 months]

    assessed by corneal tomography

Secondary Outcome Measures

  1. Change in corrected distance visual acuity [6 months]

    assessed with Snellen chart

  2. Change in uncorrected distance visual acuity [6 months]

    assessed with Snellen chart

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Price Vision Group Indianapolis Indiana United States 46260

Sponsors and Collaborators

  • Price Vision Group

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Price Vision Group
ClinicalTrials.gov Identifier:
NCT03922542
Other Study ID Numbers:
  • 2019-003
First Posted:
Apr 22, 2019
Last Update Posted:
Jul 28, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2022