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

Primary Purpose

Cataract

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Femtosecond Laser Assissted Cataract Surgery

About this trial

This is an interventional treatment trial for Cataract focused on measuring Femto Cataract Surgery

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ziemer Ophthalmic Systems AG

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

FLACS Group

Manual Group

Arm Description

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

Gold Standard Method with manual rhexis with pinzette and phaco emulsification

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Intra- and post- surgical complications

Diagnosis of Complications in combination with usual follow-up measures

Cumulative dissipated energy (CDE)

Recording of CDE on Phaco device

Ultrasound (US) total time

Record of US Energy applied

Estimated fluid usage (EFU)

Record of EFU

Corneal thickness (CCT)

Mesurement of the Central Corneal Thickness

Uncorrected distance visual acuity (UDVA)

Measurement of UDVA

Corrected distance visual acuity (CDVA)

Measurement of CDVA

Full Information

NCT ID

NCT03953053

First Posted

May 15, 2019

Last Updated

December 23, 2021

Sponsor

Ziemer Ophthalmic Systems AG

1. Study Identification

Unique Protocol Identification Number

NCT03953053

Brief Title

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

Acronym

Z8CAT01

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

June 3, 2019 (Actual)

Primary Completion Date

June 4, 2020 (Actual)

Study Completion Date

June 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ziemer Ophthalmic Systems AG

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

Keywords

Femto Cataract Surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

132 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FLACS Group

Arm Type

Experimental

Arm Description

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

Arm Title

Manual Group

Arm Type

Active Comparator

Arm Description

Gold Standard Method with manual rhexis with pinzette and phaco emulsification

Intervention Type

Device

Intervention Name(s)

Femtosecond Laser Assissted Cataract Surgery

Intervention Description

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

Primary Outcome Measure Information:

Title

Endothelial cell loss

Description

Time Frame

4 month

Secondary Outcome Measure Information:

Title

Intra- and post- surgical complications

Description

Diagnosis of Complications in combination with usual follow-up measures

Time Frame

4 month

Title

Cumulative dissipated energy (CDE)

Description

Recording of CDE on Phaco device

Time Frame

4 month

Title

Ultrasound (US) total time

Description

Record of US Energy applied

Time Frame

4 month

Title

Estimated fluid usage (EFU)

Description

Record of EFU

Time Frame

4 month

Title

Corneal thickness (CCT)

Description

Mesurement of the Central Corneal Thickness

Time Frame

4 month

Title

Uncorrected distance visual acuity (UDVA)

Description

Measurement of UDVA

Time Frame

4 month

Title

Corrected distance visual acuity (CDVA)

Description

Measurement of CDVA

Time Frame

4 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

A-Yong Yu, MD PHD Prof.

Organizational Affiliation

The Eye Hospital of Wenzhou Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ziemer Ophthalmic Systems AG

City

Port

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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