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

Technolas Perfect Vision

Status and phase: Completed; Phase 4

Conditions: Cataract

Treatments: Device: Femtosecond laser cataract surgery; Procedure: Manual cataract surgery

Study type: Interventional

Funder types: Industry

Identifiers

NCT01971177

1304

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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
• Epilepsy
• Recurrent corneal erosion
• Severe basement membrane disease
• Patients who suffer from severe wound-healing disorders such as connective tissue disease, autoimmune illnesses, immunodeficiency illnesses,endocrine diseases, lupus, rheumatoid arthritis, collagenosis, or clinically significant atopy
• Patients suffering from AIDS or HIV.
• Chemosis
• Significant loss of stability of the conjunctiva
• Nystagmus
• On a keratometric map of the cornea, the minimum and maximum K-values of the central 3 mm zone must not differ by more than 5 D.
• The maximum K-values must not exceed 60 D. The minimum value must not be smaller than 37 D.
• Patients who are pregnant or nursing.
• Patients who are blind in the fellow eye.
• Known sensitivity to planned concomitant medications.
• Patients with a recurrent or active ocular or uncontrolled eyelid disease.
• Subjects with a poorly dilating pupil.
• Patients with an anterior chamber depth (ACD) < 1.5 mm or ACD > 4.8 mm
• Presence of blood or other material in the anterior chamber.
• A history of lens instability (eg. posterior polar cataract, traumatic cataract) or zonular instability

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Femtosecond laser cataract surgery

Experimental group

Description:

"Laser group": a pre-fragmentation of the ocular lens will be performed by VICTUS femtosecond laser lens fragmentation procedure.

Treatment:

Device: Femtosecond laser cataract surgery

Manual cataract surgery

Active Comparator group

Description:

"Manual": manual group acts as a control group where the lens fragmentation are performed manually without femtosecond laser assisted lens fragmentation

Treatment:

Procedure: Manual cataract surgery