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Recruiting

NCT Number: NCT07841470

Corneal Crosslinking for Treatment of Progressive Keratoconus or Corneal Ectasia

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

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Key information

Age range

10 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location status: Recruiting

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Change in maximum keratometry

    Time frame: 6 months

    assessed with corneal tomography

Secondary outcomes

  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

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Price Vision Group

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2030
Study completion
2031
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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