McNeel Eye Center Corneal Crosslinking Study

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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02921009

Enrollment

100

Registered

2016-09-30

Start date

2016-09-01

Completion date

2025-12-31

Last updated

2025-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keratoconus

Brief summary

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.

Detailed description

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.

Interventions

DEVICECrosslinking using UV light of two different fluence rates

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Post treatment topographic analysis of Crosslinked patients	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

Measure	Time frame	Description
Post Treatment Best Corrected Visual Acuity	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026