McNeel Eye Center Corneal Crosslinking Study

Keratoconus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02921009
• Other study ID #: MEC CxL Transepithelial
• Status: Recruiting
• Phase: N/A
• Start date: September 2016
• Est. completion date: December 2022

Study information

• Verified date: September 2022
• Source: McNeel Eye Center
• Contact: Brian J McNeel, OD
• Phone: 2089382010
• Email: bjmcneelod[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Keratoconus

Intervention

Device:
• Crosslinking 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.

Locations

Country	Name	City	State
United States	McNeel Eye Center	Boise	Idaho

Sponsors (1)

Lead Sponsor	Collaborator
McNeel Eye Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post treatment topographic analysis of Crosslinked patients	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.	One Year
Secondary	Post Treatment Best Corrected Visual Acuity	Best Corrected Visual acuity will be measured post treatment out to one year. Success will be determined by improvement in best corrected acuity.	One Year