Corneal Cross-Linking Comparing Variables

Phase 3

• Conditions: Unstable Corneas
• Interventions: Drug: Epithelium-On Riboflavin; Drug: Epithelium-Off Riboflavin; Device: UV Light - Continuous Beam; Device: UV Pulsed Beam

• Registration Number: NCT02095730
• Lead Sponsor: Crowd Health Research, LTD

Brief Summary

The purpose of this study is to evaluate the Safety and Efficacy of Corneal Cross Linking in a Continuous Beam versus Pulsed Treatments across epithelium on and epithelium off surfaces.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-03
• Study First Submitted: 2014-03-20
• Study First Submitted QC: 2014-03-21
• Last Update Submitted: 2014-03-21
• Study First Posted: 2014-03-26
• Last Update Posted: 2014-03-26
• Study Start: 2014-05
• Primary Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

• Eyes classified as either normal, atypical normal,
• Corneal pachymetry ≤ 350 microns at the thinnest point measured by Orbscan, Pentacam, or ultrasound in the eye to be treated
• A history of chemical injury or delayed epithelial healing in the eye to be treated.
• A known sensitivity to study medications
• Patients with significant nystagmus or any other condition that would prevent a steady gaze during the treatment
• Inability to cooperate with diagnostic tests.
• Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing.
• Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment.
• Patients who are unable to remain comfortable and stable, and tolerate a lid speculum for the appointed period of time for the procedure.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epi-On Continuous	Epithelium-On Riboflavin	Continuous beam of UV light treating cornea with surface epithelium present
Epi-On Continuous	UV Light - Continuous Beam	Continuous beam of UV light treating cornea with surface epithelium present
Epi-Off Continuous	Epithelium-Off Riboflavin	Continuous beam of UV light treating cornea without surface epithelium present
Epi-Off Continuous	UV Light - Continuous Beam	Continuous beam of UV light treating cornea without surface epithelium present
Epi-On Pulsed	Epithelium-On Riboflavin	Pulsed beam of UV light treating cornea with surface epithelium present
Epi-On Pulsed	UV Pulsed Beam	Pulsed beam of UV light treating cornea with surface epithelium present
Epi-Off Pulsed	Epithelium-Off Riboflavin	Pulsed beam of UV light treating cornea without surface epithelium present
Epi-Off Pulsed	UV Pulsed Beam	Pulsed beam of UV light treating cornea without surface epithelium present

Primary Outcome Measures

Name	Time	Method
Visual Acuity	2 years	Uncorrected visual acuity

Trial Locations

Locations (16)

Loden Vision Centers; 🇺🇸 Goodlettsville, Tennessee, United States

LaserVue Eye; 🇺🇸 Santa Rosa, California, United States

Carolina Eye Care; 🇺🇸 Mt. Pleasant, South Carolina, United States

Icon Lasik; 🇺🇸 Denver, Colorado, United States

Eye Consultants of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Gulani Vision Institute; 🇺🇸 Jacksonville, Florida, United States

James Lewis MD PC; 🇺🇸 Elkins Park, Pennsylvania, United States

Liberty Laser Eye Center; 🇺🇸 Vienna, Virginia, United States

Southern Eye Center; 🇺🇸 Hattiesburg, Mississippi, United States

Midwest Center for Sight; 🇺🇸 Des Plaines, Illinois, United States

LASIK of Nevada; 🇺🇸 Las Vegas, Nevada, United States

Parkhurst NuVision; 🇺🇸 San Antonio, Texas, United States

Mercy Clinic Eye Specialists; 🇺🇸 Springfield, Missouri, United States

Memorial Eye Institute; 🇺🇸 Harrisburg, Pennsylvania, United States

Discover Vision Center; 🇺🇸 Leawood, Kansas, United States

Bond Eye Associates; 🇺🇸 Pekin, Illinois, United States