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Long Term Safety and Effectiveness of VEGA UV-A CXL in Keratoconus and Ectasia
NCT01398852Phase 3
Key facts
- Status
- Terminated
- Start
- Dec 2010
- Primary completion
- Jul 2012
- Countries
- 1
- Sponsor
- Topcon Healthcare
- Modality
- Orthosteric Ligands, Metabolically Activated Prodrugs
- Drugs
- riboflavin
- Conditions
- keratoconuscorneal ectasia
01
Overview
Phase 3, open-label, single-arm trial of riboflavin in keratoconus and corneal ectasia, sponsored by Topcon Healthcare. Primary endpoint: Changes in Corneal Curvature at 24 months. Started Dec 2010; status: terminated.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
CXL Treatment
Riboflavin solution + VEGA UV-A Illumination System
03
Who it enrols
Patients 12 years or older with keratoconus or ectasia, corneal pachymetry >= 400 microns, and no history of corneal surgery (for keratoconus patients).
04
Endpoints
Primary
Changes in Corneal Curvature
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