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

NCT03953053 | Completed

• 1 other identifier: FL5940-0001-CN
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

Femto Cataract Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Intra- and post- surgical complications

  4 month

• Cumulative dissipated energy (CDE)

  4 month

• Ultrasound (US) total time

  4 month

• Estimated fluid usage (EFU)

  4 month

• Corneal thickness (CCT)

  4 month

Study Arms (2)

FLACS Group

EXPERIMENTAL

Femto Laser treated (anterior Capsulotomy and Fragmentation of lens body before phaco emulification)

Device: Femtosecond Laser Assissted Cataract Surgery

Manual Group

ACTIVE COMPARATOR

Gold Standard Method with manual rhexis with pinzette and phaco emulsification

Device: Femtosecond Laser Assissted Cataract Surgery

Interventions

Femtosecond Laser Assissted Cataract Surgery DEVICE

During routine Catarct Surgery the Femtolaser cuts a ACCC (Anterior Continous Curvilinear Capsulotomy) into the lensbag and fragmentise the cataract affilited lens body

FLACS Group; Manual Group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ziemer Ophthalmic Systems AG: lead

Study Sites (1)

Ziemer Ophthalmic Systems AG

Port, Switzerland

Location

Related Publications (1)

• Zhou KJ, Huang Y, Wang Y, Pan AP, Shao X, Tu RX, Yu AY. Safety and efficacy of cataract surgery performed with a low-energy femtosecond laser compared with conventional phacoemulsification in Chinese patients: a randomized clinical trial. Eye Vis (Lond). 2023 Jul 2;10(1):31. doi: 10.1186/s40662-023-00347-0.

  PMID: 37393278 DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• A-Yong Yu, MD PHD Prof.

  The Eye Hospital of Wenzhou Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: May 16, 2019
• Study Start: June 3, 2019
• Primary Completion: June 4, 2020
• Study Completion: June 4, 2020
• Last Updated: December 27, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)