NCT02023437

Long-term (3 Months) Safety of Femtosecond-laser Assisted Cataract Surgery

A Prospective, Post-Market-Clinical-Follow-Up Study to Investigate the Long-term (3 Months) Safety of Femtosecond-laser Assisted Cataract Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Technolas Perfect Vision GmbH · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

This clinical study is a prospective, post-market-clinical-follow-up study to investigate the long-term (3 months) safety of femtosecond laser assisted cataract surgery as a study follow-up extension to the Study #1304 titled as "A Multi-centre, Multi-surgeon, Randomized, Controlled, Prospective, Post-Market-Clinical-Follow-Up Study to Investigate the Impact of Cataract Grade on the Efficacy and Safety of Femtosecond-laser Assisted Lens Fragmentation Procedure".

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	Femtosecond laser cataract surgery	The VICTUS lens fragmentation procedure is part of the femtosecond laser assisted cataract procedure, which generates precise cuts inside the cataractous lens, leading to a softening and fragmentation of the lens.
DEVICE	Manual cataract surgery	"Manual": manual group acts as a control group where the lens fragmentation are per-formed manually without femtosecond laser assisted lens fragmentation

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2013-12-30
• Last updated: 2014-05-26

Locations

2 sites across 2 countries: Czechia, India