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

PHASE4CompletedINTERVENTIONAL
Enrollment

136

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

February 28, 2014

Study Completion Date

February 28, 2014

Conditions
Cataract
Interventions
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"

Trial Locations (2)

76001

Gemini Eye Clinic, Zlín

500082

MaxiVision Laser Centre Private Limited, Hyderabad

All Listed Sponsors
lead

Technolas Perfect Vision GmbH

INDUSTRY

NCT01971177 - Addressing of Efficacy and Safety of Femtosecond-laser Assisted Versus Manual Lens Fragmentation Procedure | Biotech Hunter | Biotech Hunter