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

Cataract Clinical Trial

— Z8CAT01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03953053
• Other study ID #: FL5940-0001-CN
• Status: Completed
• Phase: N/A
• Start date: June 3, 2019
• Est. completion date: June 4, 2020

Study information

• Verified date: December 2021
• Source: Ziemer Ophthalmic Systems AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: June 4, 2020
• Est. primary completion date: June 4, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

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

Locations

Country	Name	City	State
Switzerland	Ziemer Ophthalmic Systems AG	Port

Sponsors (1)

Lead Sponsor	Collaborator
Ziemer Ophthalmic Systems AG

Country where clinical trial is conducted

Switzerland, 

Outcome

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