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

Phase 4

Completed

• Conditions: Cataract

• Registration Number: NCT02023437
• Lead Sponsor: Technolas Perfect Vision GmbH

Brief 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".

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-06
• Study First Submitted QC: 2013-12-23
• Study First Posted: 2013-12-30
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-22
• Last Update Posted: 2014-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Adverse Events	3 month	Less or equal adverse events (e.g. retinal detachment, intraocular lens (IOL) malposition, etc.) in "Laser group" (pooled from all cataract grades) compared with "Manual group" (pooled from all cataract grades); p\<0.05 will be considered statistically significant. The primary study end point is only based on adverse events and severe adverse events which are related to the treatment procedures.

Trial Locations

Locations (2)

Gemini Eye Clinic; 🇨🇿 Zlin, Czech Republic

MaxiVision Laser Centre Private Limited; 🇮🇳 Hyderabad, India