McNeel Eye Center Corneal Crosslinking Study

NCT02921009 | Active Not Recruiting

• 1 other identifier: MEC CxL Transepithelial
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Post Treatment Best Corrected Visual Acuity

  One Year

Study Arms (1)

Crosslinking at different fluence rates

EXPERIMENTAL

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

Interventions

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.

Crosslinking at different fluence rates

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• McNeel Eye Center: lead

Study Sites (1)

McNeel Eye Center

Boise, Idaho, 83713, United States

Location

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Study Officials

• Brian J McNeel, OD

  McNeel Eye Center

  STUDY DIRECTOR

• Gregory Kent, MD

  The Eye Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: O.D., F.A.A.O.

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: September 30, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2022
• Study Completion: December 31, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 90 days of the completion of the study, anticipated to be in December of 2018.
• Access Criteria: Via email - bjmcneelod@yahoo.com

Locations

US (1)