NCT01971177

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

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Technolas Perfect Vision GmbH · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cataract

Interventions

Type	Name	Description
DEVICE	Femtosecond laser cataract surgery	The VICTUS lens fragmentation procedure is part of the femtosecond laser assisted cataract procedure, which generates precise cuts inside the cataractous lens, leading to a softening and fragmentation of the lens. The correct positioning of the cuts inside the lens can be verified by means of an optical coherence tomograph (OCT) before starting the laser assisted fragmentation process. Various surgical patterns will be used within this study. For each pattern different geometry/laser parameters can be adjusted individually according to each patient's cataract status. All the patients who are enrolled in the laser groups (all cataract grades) will be treated with femtosecond laser assisted capsulotomy before the femtosecond laser assisted lens fragmentation by VICTUS femtosecond laser platform.
PROCEDURE	Manual cataract surgery	"Manual": manual group acts as a control group where the lens fragmentation are per-formed manually without femtosecond laser assisted lens fragmentation

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2013-10-29
• Last updated: 2014-03-14

Locations

2 sites across 2 countries: Czechia, India