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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02921009
Other study ID # MEC CxL Transepithelial
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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