NCT02351271

Cataract Surgery: Femto LDV Z8 Versus Conventional

A Single Centre Randomized Eye Study to Compare the Performance and Safety of Femtosecond Laser-assisted Cataract Procedures With Conventional Ultrasound-assisted Cataract Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Ziemer Ophthalmic Systems AG · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to demonstrate the performance and safety of the Femtosecond laser-assisted anterior capsulotomy and lens fragmentation on human eyes using the FEMTO LDV Z8 compared to conventional technique in cataract surgery.

Detailed description

Cataract Surgery according to conventional procedure, with the exception of two steps (Capsulotomy and Lens Fragmentation) which are performed with a Femtosecond Laser in the study group. Used equipment for measurements is the same for both groups and in line with the normal equipment used for the conventional cataract treatment (group A) Cataract surgery will be performed conventionally, this means the capsulorhexis will be performed manually by a hook, and the lens extraction will be done by phacoemulsification. (group B)

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	Femto LDV Z8	Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification
DEVICE	Manual capsulorhexis&lens fragmentation	Control treatment where the capsulorhexis is performed manually and the lens fragmentation is performed by the stop and chop technique with the phaco emulsification device

Timeline

• Start date: 2015-02-01
• Primary completion: 2016-12-28
• Completion: 2017-02-28
• First posted: 2015-01-30
• Last updated: 2019-10-23
• Results posted: 2019-10-23