NCT01373853

A Single Centre Study to Compare the Efficacy and Safety of Femtosecond Laser-Assisted Versus Manual Cataract Surgery

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Technolas Perfect Vision GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical study is a controlled, open, prospective, single-centre, multi-surgeon eye study to determine the safety and efficacy of intraocular cuts for femtosecond laser assisted lens frag-mentation to support phacoemulsification of the cataractous lens prior to IOL implantation. The cuts are applied by means of the FEMTEC femtosecond laser system with the CustomLens soft-ware module using a cylindrical and radial cut pattern with diameter and height dependent on anterior chamber depth, pupil diameter and ocular lens size. The hypothesis of the study is that by means of femtosecond laser assisted lens fragmentation the required ultrasound energy used for phacoemulsification can be reduced in a safe and effective way.

Conditions

• Cataract

Interventions

Type	Name	Description
PROCEDURE	Lens Fragmentation by means of a femtosecondlaser	In Group A the anterior capsulotomy and a pre-fragmentation of the ocular lens will be performed by means of femtosecond laser surgery.
PROCEDURE	Manual Phacoemulsification	Group B acts as a control group where the capsulotomy and lens fragmentation are performed manually

Timeline

• Start date: 2011-04-01
• Primary completion: 2011-09-01
• Completion: 2011-12-01
• First posted: 2011-06-15
• Last updated: 2015-05-20

Locations

1 site across 1 country: India