Addressing of Efficacy and Safety of Femtosecond-laser Assisted Versus Manual Lens Fragmentation Procedure

Cataract Clinical Trial

Official title: 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

Status Completed

Clinical Trial Summary

This clinical study is a randomized, controlled, open, prospective, multi-centre, multi-surgeon post-market-clinical-follow-up study to investigate the impact of cataract grade on the efficacy and safety of femtosecond laser assisted lens fragmentation to support phacoemulsification of the cataractous lens prior to intraocular lens (IOL) implantation.

Clinical Trial Description

The purpose of the multi-centre, multi-surgeon, randomized, controlled, prospective, post-market-clinical-follow-up study clinical study is to investigate the impact of cataract grade on the safety and efficacy of femtosecond laser assisted lens fragmentation for cataract surgery by using VICTUS femtosecond laser platform.

In this study patients with different cataract grades [judged by lens opacity classification system (LOCS) III on nuclear opalescence) will be randomly assigned to either a manual group or a laser group, and aspects on efficacy and safety will be investigated.

• The sponsor and the investigators ensure, that all relevant documents are approved by their institutional review board / institutional ethics committee (IRB/IEC), or if not using their institution's IRB/IEC, approved by the reviewing central IRB/IEC prior to entering any subjects in the study.

• To avoid any potential bias during the process of patient assignment and in order to observe fair and true clinical significance a block randomization method will be employed and applied during the study.

• Subjects are regarded as enrolled to the clinical trial population as soon as they have signed and received the patient informed consent form (ICF) and underwent preoperative examinations.

• The sponsor's clinical group will accompany and monitor this study in respect to patient enrolment, eligibility control, randomization process, postoperative monitoring and data collection in accordance with the applicable regulations and the specifications required by the sponsor.

• All medical information obtained at each study visit will be recorded in the subject's record (source documentation) in real time as it is collected and then transcribed onto the case report form (CRF) by site personnel. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract

• NCT number: NCT01971177
• Study type: Interventional
• Source: Technolas Perfect Vision GmbH
• Status: Completed
• Phase: Phase 4
• Start date: October 2013
• Completion date: February 2014