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NCT Number: NCT02921009

McNeel Eye Center Corneal Crosslinking Study

This study will investigate the effectiveness in treating keratoconus, pellucid marginal degeneration and post LASIK iatrogenic ectasia utilizing fluence rates and treatment times of Corneal Cross Linking other than the original FDA approved protocol of 3mw/cm2.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases

Age range

15 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McNeel Eye Center

Boise, Idaho, 83713, United States

About this study

Patient recruitment will include a patient population of 100 individuals from 15 years to 50 years old with established keratoconus, pellucid marginal degeneration or post-LASIK ectasia determined by keratography. A solution of transepithelial riboflavin .25% will be applied every three minutes for 30 minutes or until complete corneal penetration is observed. Then the cornea will be irradiated with UV light at fluence rates of 9mw/cm2 for 10 minutes or 18 mw/cm2 for 5 minutes. Post procedural evaluation will take place at day one, day 7 day 30, day 90, day 180 and day 365. Pretreatment keratography, uncorrected acuity, best corrected acuity will be compared at follow up days beginning on day 30.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males or females between the ages of 15 and 50 with keratoconus diagnosed topographically with or without other corneal ectatic disease.

Exclusion criteria

  • Prior corneal transplantation, pregnancy, inability or unwillingness to adhere to follow up protocol.

Treatment and study plan

Crosslinking using UV light of two different fluence rates

Device

The treatment of keratoconus involves the application of riboflavin followed by Ultraviolet light of differing intensities. This study will determine the effectiveness of a greater UV light fluence at a shorter treatment time than is currently utilized.

Primary outcomes

  1. Post treatment topographic analysis of Crosslinked patients

    Time frame: One Year

    Pre-treatment videokeratography will be compared to post treatment keratography at certain intervals up to one year. Overall flattening of corneal curvature will be a primary study item.

Secondary outcomes

  1. Post Treatment Best Corrected Visual Acuity

    Time frame: One Year

    Best Corrected Visual acuity will be measured post treatment out to one year. Success will be determined by improvement in best corrected acuity.

Sponsors and collaborators

Lead sponsor

McNeel Eye Center

Industry

Registry information

Official study title

Study of Effectiveness and Safety of Transepithelial Collagen Cross-linking at Varying Fluence Levels.

Important dates

Study start
2016
Primary completion
2022
Study completion
2025
First posted
Sep 30, 2016
Registry last updated
Apr 6, 2025

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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