Cataract Clinical Trial
Official title:
A Single Centre Study to Compare the Efficacy and Safety of Femtosecond Laser-Assisted Versus Manual Cataract Surgery
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.
n/a
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
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