Cataract Surgery: Femto LDV Z8 Versus Conventional (COMFORT)

Ziemer

Status

Completed

Conditions

Cataract

Treatments

Device: Manual capsulorhexis&lens fragmentation

Device: Femto LDV Z8

Study type

Interventional

Funder types

Industry

Identifiers

NCT02351271

FL5940-0996

Details and patient eligibility

About

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.

Full 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)

Enrollment

130 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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