Cataract Surgery: Femto LDV Z8 Versus Conventional

Not Applicable

Completed

Interventions: Device: Femto LDV Z8
Device: Manual capsulorhexis&lens fragmentation

Brief Summary: The aim of the study is to demonstrate the performance and safety of the Femtosecond laser-assisted anterior capsulotomy and lens fragmentation on human eyes using the FEMTO LDV Z8 compared to conventional technique in cataract surgery.

Detailed Description: Cataract Surgery according to conventional procedure, with the exception of two steps (Capsulotomy and Lens Fragmentation) which are performed with a Femtosecond Laser in the study group. Used equipment for measurements is the same for both groups and in line with the normal equipment used for the conventional cataract treatment (group A) Cataract surgery will be performed conventionally, this means the capsulorhexis will be performed manually by a hook, and the lens extraction will be done by phacoemulsification. (group B)

Recruitment & Eligibility

Inclusion Criteria

Eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens Implantation
Able to co-operate with the docking system for the femtosecond laser
Clear corneal media
50 years of age or older
Willing and able to return for scheduled follow-up examinations

Exclusion Criteria

Minimal and maximal K-values of the central 3mm zone that differ by more than 5D on a keratometric map of the cornea
Maximum K-value that exceeds 58D
Minimal K-value of less than 37D
Corneal disease or pathology, such as corneal scaring or opacity, that precludes transmission of laser wavelength or that distorts laser light
Poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally
Manifest Glaucoma+OHT (ocular hypertension), pseudoexfoliation
Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye
Known sensitivity to planned concomitant medications
History of lens or zonular instability
Keratoconus or keratectasia
Immune compromised or diagnosis of connective tissue disease, clinically sign. atopic disease, insulin dependent diabetes mellitus, autoimmune diseases, ocular herpes zoster or simplex, endocrine diseases, lupus, RA, collagenosis and other acute or chronic illnesses that increases the risk to the subject or confounds the outcomes of this study, in the opinion of the study PI.
Anterior chamber depth (ACD) < 1.5 mm or ACD > 4.8 mm as measured from the corneal endothelium.
Extensive corneal scarring
Developmental disability or cognitive impairment (would preclude adequate comprehension of the Informed Consent (IC) form and/or the ability to record the study measurements)
Concurrent participation in another ophthalmological clinical study

Arm && Interventions

Group	Intervention	Description
Femto LDV Z8	Femto LDV Z8	Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification
Manual capsulorhexis&lens fragmentation	Manual capsulorhexis&lens fragmentation	The Conventional group acts as a control group with conventional capsulorhexis and ultrasound phacoemulsification

Primary Outcome Measures

Name	Time	Method
Effective Phaco Time (EPT)	day of surgery	Effective Phacoemulsification Time (EPT): EPT for eyes receiving Intervention A being statistically same or lower than EPT for eyes receiving Intervention B at p\<0.05 will be considered positive for superior efficacy of application of FEMTO LDV Z8 over the manual procedure Effective Phaco Time is a unit. It is commonly understood in the area of cataract surgery to be the standard way to describe phaco energy during a procedure over different manufactured phaco devices. Effective phaco time is the total phaco time at 100 percent phaco power. It can be less than the total foot-pedal time. Less EPT indicates proportionately less energy delivered to the eye thereby reducing the side effects of phaco power.

Secondary Outcome Measures

Name	Time	Method
Ease of Phacoemulsification	during surgery	Ease of phacoemulsification was performed as a subjective observation by the surgeon. Four classifications were possible: easy - phacoemulsification was fast and uncomplicated; 'slight resistance' - phacoemulsification encountered some difficulty; 'resistance noted' - phacoemulsification was somewhat complex; 'difficult' - phacoemulsification was difficult and complex to complete.
Number of Participants With Complete Treatment Pattern	during surgery	Completeness of capsulotomy is a subjective metric given by the surgeon. Measurements were scaled into the following four categories: 1: complete treatment pattern; 2: micro-adhesion; 3: incomplete treatment pattern; 4: complete pattern but not continuous. "Complete treatment pattern" is considered the best result, "micro adhesion" indicates a minor but manageable problem, "incomplete treatment pattern" indicates a treatable, but more complex suboptimal outcome and "complete treatment but discontinuous pattern" indicates the treatable but suboptimal outcome.