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

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".

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gemini Eye Clinic, Zlín, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Femtosecond laser cataract surgery

Device

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

Device

"Manual": manual group acts as a control group where the lens fragmentation are per-formed manually without femtosecond laser assisted lens fragmentation

Primary outcomes

Adverse Events

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Technolas Perfect Vision GmbH

Industry

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Dec 30, 2013
Registry last updated: May 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed