Clinical trial NCT01971177: Addressing of Efficacy and Safety of Femtosecond-laser Assisted Versus Manual Lens Fragmentation Procedure
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cataract
Lead sponsor: Technolas Perfect Vision GmbH
Sponsor class: INDUSTRY
First posted: 2013-10-29
Enrollment: 136
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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

Primary outcomes:
measure: Effective Phacoemulsification Time
timeFrame: This criterion should be achieved at the day of treatment.
Secondary outcomes:
measure: Adverse Events
timeFrame: This purpose criterion should be achieved intraoperative, at 1 day, 1 week and 1 month.
Other outcomes:
Locations:
city: Zlin
country: Czech Republic
facility: Gemini Eye Clinic
city: Hyderabad
country: India
facility: MaxiVision Laser Centre Private Limited
Study officials:
affiliation: Gemini clinic, Zlin, Czech Republic 76001
name: Pavel Stodulka, Dr. med
role: PRINCIPAL_INVESTIGATOR
affiliation: MaxiVision Laser Centre Private Limited, Hyderabad, India
name: Kasu Prasad Reddy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MaxiVision Laser Centre Private Limited, Hyderabad, India
name: N Sreelakshmi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Slade & Baker Vision Center
name: Stephen Slade, MD
role: STUDY_CHAIR
References: