Recruiting
Phase 2
Phase 3

Standard vs. Accelerated

Sponsor:

Price Vision Group

Code:

NCT03922542

Conditions

Keratoconus

Ectasia Corneal

Eligibility Criteria

Sex: All

Age: 10+

Healthy Volunteers: Not accepted

Interventions

riboflavin 0.1%

Riboflavin 0.1%

Study Details

Brief summary:

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

Conditions

Keratoconus

Ectasia Corneal

Study ID

NCT03922542

Start date

Apr 16, 2019

Status verified date

Jul, 2025

Completion date

Jul 1, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

510 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Accelerated

Treatment with 0.1% riboflavin 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

Interventions

riboflavin 0.1%

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

Riboflavin 0.1%

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

Primary outcome measure

  • Change in maximum keratometry [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Marianne Price, PhD

317-814-2990mprice@cornea.org

Locations

Price Vision Group

Recruiting

Indianapolis, Indiana, United States, 46260

Contacts

Marianne Price, Ph.D

317-814-2990marianneprice@cornea.org

Principal Investigator:

Francis Price, MD

More Information

Sponsor

Price Vision Group

Last update posted

Jul 31, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Price Vision Group on 2025-07-31.