NCT02762253

Study of the Safety and Effectiveness of Photochemically Induced Collagen Cross-Linking in Eyes With Keratoconus.

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Nvision Laser Eye Centers · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to assess the safety and effectiveness of photochemically induced collagen cross- linking (CCL) at irradiance of 18mW/cm2 in eyes with Keratoconus and Ecstasia.

Detailed description

Riboflavin drops are used every 2 minutes for 30+ minutes until the corneal stroma is saturated with Riboflavin as evidenced by observing Riboflavin in the Anterior chamber. Two arms in the study, one uses Riboflavin with Epithelium on and the other with Epithelium off. Once it is observed that the Riboflavin has penetrated the stroma and is seen in the anterior chamber, the cornea is exposed to Ultraviolet light at an irradiance level of 18mW/cm2 for 5 minutes. A contact lens is applied until the epithelium has fully healed in 3 to 5 days. The study is for 6 months. The corneal curvature as well as the uncorrected and best corrected vision and corneal thickness are evaluated pre-operatively and at 6 months. The primary variable that is assessed to determine the efficacy of the drug is the Kmax - Steep corneal curvature. Secondary effectiveness criteria are uncorrected and best corrected vision and corneal thickness. adverse events are also monitored.

Conditions

• Keratoconus

Interventions

Type	Name	Description
DRUG	Riboflavin drops	Riboflavin drops were used every 2 minutes for 30 minutes on the cornea then exposed to 5 minutes of Ultraviolet light at an intensity of 18mW/cm2

Timeline

• Start date: 2012-09-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2016-05-04
• Last updated: 2016-05-05

Locations

11 sites across 1 country: United States