Safety and Efficacy of FLACS With the FEMTO LDV Z8 Laser Compared to Conventional Cataract Surgery in Chinese Patients (Z8CAT01)

Ziemer

Status

Completed

Conditions

Cataract

Treatments

Device: Femtosecond Laser Assissted Cataract Surgery

Study type

Interventional

Funder types

Industry

Identifiers

NCT03953053

FL5940-0001-CN

Details and patient eligibility

About

This trial will be designed as a multi-center randomized non-inferiority clinical trial to demonstrate safety and efficacy of the FEMTO LDV Z8 laser for cataract surgery in a Chinese population in China compared to the conventional technique.

Full description

In this three center, prospective, interventional, randomized controlled study we aim to determine safety and efficacy of the FEMTO LDV Z8 laser as compared to conventional technique in Chinese patients diagnosed with cataract of any severity grade that are eligible to undergo cataract surgery with age 50 years and a maximum age of 80 years in China.

Enrollment

132 patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Eligible to undergo cataract extraction by phacoemulsification with primary intraocular lens implantation
Provision of signed and dated informed consent form
Male or female, between 50 and 80 years of age (50 and 80 are included).
IOL chosen for implantation a monofocal aspheric IOL of 6mm optic diameter
Willing to comply with all study procedures and able to return for scheduled follow-up examinations
Willing to adhere to the medication (to prevent inflammation and infection) regimen

Exclusion criteria

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 (e.g., intraoperative floppy iris syndrome)
Glaucoma or ocular hypertension, pseudoexfoliation
Corneal endothelial pathology where endothelial cell count is compromised (Fuchs endothelial dystrophy and others)
Complicated cataract, such as traumatic, white, intumescent or posterior and anterior subcapsular cataracts
Nystagmus or hemofacial spasm preventing placement of the patient interface
Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye
Allergy to medications required in surgery, pre- and post-operative treatment
History of lens or zonular instability
Keratoconus or keratectasia
Immune compromised or diagnosis of ophthalmic disease: ocular herpes zoster or simplex, lupus, 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 (Principal Investigator)
Anterior chamber depth (ACD) < 1.5 mm or > 4.8 mm as measured from the corneal endothelium.
Developmental disability or cognitive impairment that would make informed consent and the assessment of visual acuity impossible
Concurrent participation in another ophthalmological clinical study