NCT02009709

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

Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking at an Irradiance of 9 mW/cm2 and 18 mW/cm2 in Eyes With Keratoconus or Ectasia

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Robert Mack, M.D. · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Keratoconus
• Corneal Ectasia

Interventions

Type	Name	Description
DRUG	Riboflavin 0.1% ophthalmic solution	Instillation of 0.1% riboflavin ophthalmic solution, one drop every 3 minutes for 30 minutes before the procedure and one drop every 3 minutes during the procedure.
DEVICE	CCL-VARIO UV lamp	Application of ultraviolet light on the eye to be treated at an irradiance of 9 mW/cm2 for 10 minutes
DEVICE	CCL-VARIO at 18 mW/cm2	Application of ultraviolet light on the eye to be treated at an irradiance of 18 mW/cm2 for 5 minutes.

Timeline

• Start date: 2013-10-01
• Primary completion: 2017-01-01
• First posted: 2013-12-12
• Last updated: 2015-12-14

Locations

1 site across 1 country: United States