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

NCT ID: NCT03953053

Last Updated: 2021-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-03
• Study Completion Date: 2020-06-04

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.

Conditions

Cataract

Keywords

Femto Cataract Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FLACS Group

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

Group Type: EXPERIMENTAL

Femtosecond Laser Assissted Cataract Surgery

Intervention Type: DEVICE

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

Manual Group

Gold Standard Method with manual rhexis with pinzette and phaco emulsification

Group Type: ACTIVE_COMPARATOR

Femtosecond Laser Assissted Cataract Surgery

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ziemer Ophthalmic Systems AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

A-Yong Yu, MD PHD Prof.

Role: PRINCIPAL_INVESTIGATOR

The Eye Hospital of Wenzhou Medical University

Locations

Ziemer Ophthalmic Systems AG

Port, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 37393278 (View on PubMed)

Other Identifiers

FL5940-0001-CN

Identifier Type: -

Identifier Source: org_study_id