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
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Cataract
- Sponsor
- Technolas Perfect Vision GmbH
- Enrollment
- 136
- Locations
- 2
- Primary Endpoint
- Effective Phacoemulsification Time
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must have read, understood and signed the Patient Information
- •Patients are willing and able to return for follow-up examinations
- •Clear corneal media
- •Cataract grade (nuclear) from I to V according to LOCS III
- •Patients must be at least 40 years of age
Exclusion Criteria
- •Patients presenting a clear lens (clear lens exchange)
- •Glaucoma and suspected glaucoma
- •Patients with pre-existing proliferative diabetic retinopathy (mild and tight controlled diabetes symptoms, without retinopathy and non-proliferative diabetic retinopathy, can be included.)
- •Retinal disorders
- •Rheumatic diseases
- •Occlusion of retinal vessels
- •Pellucid marginal degeneration
- •Herpes zoster or herpes simplex keratitis
- •Heavy vascularization of the ocular tissue
- •Recurrent corneal erosion
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Adverse Events(This purpose criterion should be achieved intraoperative, at 1 day, 1 week and 1 month.)