Study of the Safety and Effectiveness of Collagen Cross-Linking at an Irradiance of 9 mW/cm2 and 18 mW/cm2

Phase 1

• Conditions: Keratoconus; Corneal Ectasia
• Interventions: Drug: Riboflavin 0.1% ophthalmic solution; Device: CCL-VARIO at 18 mW/cm2; Device: CCL-VARIO UV lamp

• Registration Number: NCT02009709
• Lead Sponsor: Robert Mack, M.D.

Brief Summary

The primary objective of this study is to determine the effectiveness and safety of corneal collagen cross-linking at irradiance levels of 9 and 18 mW/cm2.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-12-09
• Study First Submitted QC: 2013-12-09
• Study First Posted: 2013-12-12
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-10
• Last Update Posted: 2015-12-14
• Primary Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
18 mW/cm2	CCL-VARIO at 18 mW/cm2	CCL-VARIO at 18 mW/cm2 Riboflavin 0.1% ophthalmic solution
9 mW/cm2	CCL-VARIO UV lamp	CCL-VARIO UV lamp Riboflavin 0.1% ophthalmic solution
18 mW/cm2	Riboflavin 0.1% ophthalmic solution	CCL-VARIO at 18 mW/cm2 Riboflavin 0.1% ophthalmic solution
9 mW/cm2	Riboflavin 0.1% ophthalmic solution	CCL-VARIO UV lamp Riboflavin 0.1% ophthalmic solution

Primary Outcome Measures

Name	Time	Method
Decrease in maximum corneal curvature	3 and 6 months post-procedure

Trial Locations

Locations (1)

Mack Eye Center; 🇺🇸 Hoffman Estates, Illinois, United States