McNeel Eye Center Corneal Crosslinking Study

Sponsor

McNeel Eye Center (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02921009

Collaborator

(none)

100

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Keratoconus	Device: Crosslinking using UV light of two different fluence rates	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Crosslinking at different fluence rates The study will investigate the effectiveness of Transepithelial riboflavin .25% treated with Ultraviolet light at fluence rates of 9mw/cm2 and 18mw/cm2 in the treatment of diagnosed keratoconus, pellucid marginal degeneration or post-LASIK ectasia.	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.

Arm

Intervention/Treatment

Experimental: Crosslinking at different fluence rates

The study will investigate the effectiveness of Transepithelial riboflavin .25% treated with Ultraviolet light at fluence rates of 9mw/cm2 and 18mw/cm2 in the treatment of diagnosed keratoconus, pellucid marginal degeneration or post-LASIK ectasia.

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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McNeel Eye Center	Boise	Idaho	United States	83713

Sponsors and Collaborators

McNeel Eye Center

Investigators

Study Director: Brian J McNeel, OD, McNeel Eye Center
Principal Investigator: Gregory Kent, MD, The Eye Associates

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Brian J. McNeel, O.D., F.A.A.O., McNeel Eye Center

ClinicalTrials.gov Identifier:

NCT02921009

Other Study ID Numbers:

MEC CxL Transepithelial

First Posted:

Sep 30, 2016

Last Update Posted:

Mar 13, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Additional relevant MeSH terms:

Keratoconus

Study Results

No Results Posted as of Mar 13, 2019