Safety and Efficacy of FLACS With the FEMTO LDV Z8 Laser Compared to Conventional Cataract Surgery in Chinese Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ziemer Ophthalmic Systems AG
- Enrollment
- 132
- Locations
- 1
- Primary Endpoint
- Endothelial cell loss
Study Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
FLACS Group
Femto Laser treated (anterior Capsulotomy and Fragmentation of lens body before phaco emulification)
Intervention: Femtosecond Laser Assissted Cataract Surgery (Device)
Manual Group
Gold Standard Method with manual rhexis with pinzette and phaco emulsification
Intervention: Femtosecond Laser Assissted Cataract Surgery (Device)
Outcomes
Primary Outcomes
Endothelial cell loss
Time Frame: 4 month
To determine whether the FLACS with the FEMTO LDV Z8 laser is non-inferior to measured using the NSP 9900, KONAN MEDICAL, and calculated according to: postoperative endothelial cell loss = preoperative endothelial count - postoperative endothelial cell count
Secondary Outcomes
- Ultrasound (US) total time(4 month)
- Corneal thickness (CCT)(4 month)
- Intra- and post- surgical complications(4 month)
- Cumulative dissipated energy (CDE)(4 month)
- Uncorrected distance visual acuity (UDVA)(4 month)
- Estimated fluid usage (EFU)(4 month)
- Corrected distance visual acuity (CDVA)(4 month)