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

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.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: Femtosecond Laser Assissted Cataract Surgery

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 Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Port, Switzerland
    • Ziemer Ophthalmic Systems AG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: FLACS Group; Femto Laser treated (anterior Capsulotomy and Fragmentation of lens body before phaco emulification)	Device: Femtosecond Laser Assissted Cataract Surgery; During routine Catarct Surgery the Femtolaser cuts a ACCC (Anterior Continous Curvilinear Capsulotomy) into the lensbag and fragmentise the cataract affilited lens body
ACTIVE_COMPARATOR: Manual Group; Gold Standard Method with manual rhexis with pinzette and phaco emulsification	Device: Femtosecond Laser Assissted Cataract Surgery; During routine Catarct Surgery the Femtolaser cuts a ACCC (Anterior Continous Curvilinear Capsulotomy) into the lensbag and fragmentise the cataract affilited lens body

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial cell loss	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	4 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra- and post- surgical complications	Diagnosis of Complications in combination with usual follow-up measures	4 month
Cumulative dissipated energy (CDE)	Recording of CDE on Phaco device	4 month
Ultrasound (US) total time	Record of US Energy applied	4 month
Estimated fluid usage (EFU)	Record of EFU	4 month
Corneal thickness (CCT)	Mesurement of the Central Corneal Thickness	4 month
Uncorrected distance visual acuity (UDVA)	Measurement of UDVA	4 month
Corrected distance visual acuity (CDVA)	Measurement of CDVA	4 month

Collaborators and Investigators

• Sponsor: Ziemer Ophthalmic Systems AG
• Investigators: Principal Investigator: A-Yong Yu, MD PHD Prof., The Eye Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 3, 2019
• Primary Completion (ACTUAL): June 4, 2020
• Study Completion (ACTUAL): June 4, 2020

Study Registration Dates

• First Submitted: May 15, 2019
• First Submitted That Met QC Criteria: May 15, 2019
• First Posted (ACTUAL): May 16, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 27, 2021
• Last Update Submitted That Met QC Criteria: December 23, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Femto Cataract Surgery
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: FL5940-0001-CN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No