Addressing of Efficacy and Safety of Femtosecond-laser Assisted Versus Manual Lens Fragmentation Procedure
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|ClinicalTrials.gov Identifier: NCT01971177|
Recruitment Status : Completed
First Posted : October 29, 2013
Last Update Posted : March 14, 2014
|Condition or disease||Intervention/treatment||Phase|
|Cataract||Device: Femtosecond laser cataract surgery Procedure: Manual cataract surgery||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||136 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
Experimental: Femtosecond laser cataract surgery
"Laser group": a pre-fragmentation of the ocular lens will be performed by VICTUS femtosecond laser lens fragmentation procedure.
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.
Active Comparator: Manual cataract surgery
"Manual": manual group acts as a control group where the lens fragmentation are performed manually without femtosecond laser assisted lens fragmentation
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
- Effective Phacoemulsification Time [ Time Frame: This criterion should be achieved at the day of treatment. ]The effective phacoemulsification time (EPT) used the "Laser group" (pooled from all grades) during phacoemulsification is lower than or equal to that in the "Manual group" (pooled from all grades); p<0.05 will be considered statistically significant.
- Adverse Events [ Time Frame: This purpose criterion should be achieved intraoperative, at 1 day, 1 week and 1 month. ]Less or equal adverse events (e.g. retinal detachment, IOL malposition, etc.) in "Laser group" (pooled from all cataract grades) compared with "Manual group" (pooled from all cataract grades); p<0.05 will be considered statistically significant. The secondary study end point is only based on adverse events and severe adverse events which are related to the treatment procedures.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01971177
|Gemini Eye Clinic|
|Zlin, Czech Republic, 76001|
|MaxiVision Laser Centre Private Limited|
|Hyderabad, India, 500082|
|Principal Investigator:||Pavel Stodulka, Dr. med||Gemini clinic, Zlin, Czech Republic 76001|
|Principal Investigator:||Kasu Prasad Reddy, MD||MaxiVision Laser Centre Private Limited, Hyderabad, India|
|Principal Investigator:||N Sreelakshmi, MD||MaxiVision Laser Centre Private Limited, Hyderabad, India|
|Study Chair:||Stephen Slade, MD||Slade & Baker Vision Center|