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

Technolas Perfect Vision

Status and phase: Completed; Phase 4

Conditions: Cataract

Treatments: Device: Manual cataract surgery; Device: Femtosecond laser cataract surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT02023437

1304_3M

Details and patient eligibility

About

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".

Enrollment: 132 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

Experimental: Femtosecond laser cataract surgery

Experimental group

Description:

"Laser group": a pre-fragmentation of the ocular lens will be performed by VICTUS femtosecond laser lens fragmentation procedure.

Treatment:

Device: Femtosecond laser cataract surgery

Manual cataract surgery

Active Comparator group

Description:

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

Treatment:

Device: Manual cataract surgery