Clinical Trials Directory

Trials / Completed

CompletedNCT03953053

Safety and Efficacy of FLACS With the FEMTO LDV Z8 Laser Compared to Conventional Cataract Surgery in Chinese Patients

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
132 (actual)
Sponsor
Ziemer Ophthalmic Systems AG · Industry
Sex
All
Age
50 Years – 80 Years
Healthy volunteers
Not accepted

Summary

This trial will be designed as a multi-center randomized non-inferiority clinical trial to demonstrate safety and efficacy of the FEMTO LDV Z8 laser for cataract surgery in a Chinese population in China compared to the conventional technique.

Detailed description

In this three center, prospective, interventional, randomized controlled study we aim to determine safety and efficacy of the FEMTO LDV Z8 laser as compared to conventional technique in Chinese patients diagnosed with cataract of any severity grade that are eligible to undergo cataract surgery with age 50 years and a maximum age of 80 years in China.

Conditions

Interventions

TypeNameDescription
DEVICEFemtosecond Laser Assissted Cataract SurgeryDuring routine Catarct Surgery the Femtolaser cuts a ACCC (Anterior Continous Curvilinear Capsulotomy) into the lensbag and fragmentise the cataract affilited lens body

Timeline

Start date
2019-06-03
Primary completion
2020-06-04
Completion
2020-06-04
First posted
2019-05-16
Last updated
2021-12-27

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT03953053. Inclusion in this directory is not an endorsement.