Corneal Crosslinking for Treatment of Progressive Keratoconus or Corneal Ectasia

NCT07841470 — Phase 2 / Phase 3, Recruiting, 500 participants, Price Vision Group

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Corneal Crosslinking for Treatment of Progressive Keratoconus or Ectasia: Randomized Comparison of Pulsed vs. Non-pulsed Treatment

Registry	NCT07841470
Status	Recruiting
Phase	Phase 2 / Phase 3
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	500 (Estimated)
Sponsor	Price Vision Group (Industry)
Conditions	Keratoconus, Corneal Ectasia
Interventions	Riboflavin 0.1% ophthalmic solution and pulsed light, Riboflavin 0.1% ophthalmic solution and non-pulsed light (Combination product)
Dates	start 2025-10-01, primary completion 2030-12-31 (estimated), completion 2031-06-30 (estimated), first posted 2026-09-25, last updated 2026-09-25
Locations	1 site in United States

-Summary

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

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+Detailed description

Subjects diagnosed with keratoconus or corneal ectasia are randomized to one of two corneal crosslinking light durations.

+Arms and interventions

Arm	Type	Interventions	Description
Pulsed	Active comparator	Combination Product: Riboflavin 0.1% ophthalmic solution and pulsed light	Treatment with 0.1% riboflavin eye drops and pulsed 18 milliwatt/cm2 ultraviolet A light for 10 minutes
Non-pulsed	Active comparator	Combination Product: Riboflavin 0.1% ophthalmic solution and non-pulsed light	Treatment with 0.1% riboflavin eye drops non-pulsed 9 milliwatt/cm2 ultraviolet A light for 10 minutes

Riboflavin 0.1% ophthalmic solution and pulsed light (Combination product): 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 (Combination product): Use of riboflavin 0.1% eye drops and non-pulsed 9 milliwatt/cm2 ultraviolet A light for 10 minutes

+Outcome measures

Primary outcomes

Change in maximum keratometry [6 months]: assessed with corneal tomography

Secondary outcomes

change in corrected distance visual acuity [6 months]: assessed with Snellen chart
change in uncorrected distance visual acuity [6 months]: assessed with Snellen chart

+Eligibility

Sex: All, ages: 10 Years to 90 Years

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

+Locations (1)

Facility	City	Country	Status
Price Vision Group	Indianapolis, Indiana	United States	Recruiting

+Investigators

Francis Price, MD, Principal investigator, Price Vision Group