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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02023437
• Other study ID #: 1304_3M
• Status: Completed
• Phase: Phase 4
• First received: December 6, 2013
• Last updated: May 22, 2014
• Start date: December 2013
• Est. completion date: March 2014

Study information

• Verified date: May 2014
• Source: Technolas Perfect Vision GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics CommitteeIndia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Only the patients who were successfully enrolled in Study #1304 are eligible for this follow-up extension study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

Intervention

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.
• 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

Locations

Country	Name	City	State
Czech Republic	Gemini Eye Clinic	Zlin
India	MaxiVision Laser Centre Private Limited	Hyderabad

Sponsors (1)

Lead Sponsor	Collaborator
Technolas Perfect Vision GmbH

Countries where clinical trial is conducted

Czech Republic,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Events	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.	3 month	Yes