Clinical trial NCT02351271: Cataract Surgery: Femto LDV Z8 Versus Conventional
Official title: A Single Centre Randomized Eye Study to Compare the Performance and Safety of Femtosecond Laser-assisted Cataract Procedures With Conventional Ultrasound-assisted Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Ziemer Ophthalmic Systems AG
Sponsor class: INDUSTRY
First posted: 2015-01-30
Enrollment: 130
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Effective Phaco Time (EPT)
timeFrame: day of surgery
Secondary outcomes:
measure: Ease of Phacoemulsification
timeFrame: during surgery
measure: Number of Participants With Complete Treatment Pattern
timeFrame: during surgery
Other outcomes:
measure: Number of Participants With Reported Complications
timeFrame: during follow-up after 1 and 12 days, 4, 8 and 12 weeks
Locations:
Study officials:
affiliation: Augenzentrum ORASIS AG
name: Bojan Pajic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: