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

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Device: Femtosecond Laser Assissted Cataract Surgery

• Registration Number: NCT03953053
• Lead Sponsor: Ziemer Ophthalmic Systems AG

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 Timeline

• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-05-15
• Study First Posted: 2019-05-16
• Study Start: 2019-06-03
• Primary Completion: 2020-06-04
• Study Completion: 2020-06-04
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-23
• Last Update Posted: 2021-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FLACS Group	Femtosecond Laser Assissted Cataract Surgery	Femto Laser treated (anterior Capsulotomy and Fragmentation of lens body before phaco emulification)
Manual Group	Femtosecond Laser Assissted Cataract Surgery	Gold Standard Method with manual rhexis with pinzette and phaco emulsification

Primary Outcome Measures

Name	Time	Method
Endothelial cell loss	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 Outcome Measures

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

Trial Locations

Locations (1)

Ziemer Ophthalmic Systems AG; 🇨🇭 Port, Switzerland