Recruiting
Phase 2
Phase 3

Corneal Crosslinking

Sponsor:

Price Vision Group

Code:

NCT07841470

Conditions

Keratoconus

Corneal Ectasia

Eligibility Criteria

Sex: All

Age: 10 - 70+

Healthy Volunteers: Not accepted

Interventions

Riboflavin 0.1% ophthalmic solution and pulsed light

Riboflavin 0.1% ophthalmic solution and non-pulsed light

Study Details

Brief summary:

This randomized study compares 2 variations of corneal crosslinking for treatment of keratoconus or corneal ectasia.

Conditions

Keratoconus

Corneal Ectasia

Study ID

NCT07841470

Start date

Oct 1, 2025

Status verified date

Sep, 2026

Completion date

Jun 30, 2031

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of keratoconus or corneal ectasia
  • Provision of written informed consent

Exclusion Criteria:

  • Previous ocular condition in the study eye that may predispose for future complications including history of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)
  • Clinically significant corneal scarring in the proposed treatment zone
  • History of chemical injury or delayed epithelial healing in the study eye
  • Known sensitivity to study medication
  • A current condition, including clinically significant dry eyes or use of medications know to induce dry eye symptoms, that, in the treating physician's opinion, would interfere with or prolong epithelial healing
  • Pregnancy (including plan to become pregnant) or lactation during the course of the study

Study Design

Enrollment

500 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Pulsed

Treatment with 0.1% riboflavin eye drops and pulsed 18 milliwatt/cm2 ultraviolet A light for 10 minutes

active comparator: Non-pulsed

Treatment with 0.1% riboflavin eye drops non-pulsed 9 milliwatt/cm2 ultraviolet A light for 10 minutes

Interventions

Riboflavin 0.1% ophthalmic solution and pulsed light

Use of riboflavin 0.1% eye drops and pulsed 18 milliwatt/cm2 ultraviolet A light for 10 minutes

Riboflavin 0.1% ophthalmic solution and non-pulsed light

Use of riboflavin 0.1% eye drops and non-pulsed 9 milliwatt/cm2 ultraviolet A light for 10 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

Francis Price, MD

317-814-2823fprice@pricevisiongroup.net

Locations

Price Vision Group

Recruiting

Indianapolis, Indiana, United States, 46260

Contacts

Marianne Price, PhD

317-814-2990mprice@cornea.org

More Information

Sponsor

Price Vision Group

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Keywords

  • crosslinking
  • keratoconus

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Price Vision Group on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.