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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03953053
Recruitment Status : Completed
First Posted : May 16, 2019
Last Update Posted : December 27, 2021
Sponsor:
Information provided by (Responsible Party):
Ziemer Ophthalmic Systems AG

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cataract Device: Femtosecond Laser Assissted Cataract Surgery Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of FLACS With the FEMTO LDV Z8 Laser Compared to Conventional Cataract Surgery in Chinese Patients
Actual Study Start Date : June 3, 2019
Actual Primary Completion Date : June 4, 2020
Actual Study Completion Date : June 4, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
Experimental: FLACS Group
Femto Laser treated (anterior Capsulotomy and Fragmentation of lens body before phaco emulification)
 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
Active Comparator: Manual Group
Gold Standard Method with manual rhexis with pinzette and phaco emulsification
 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


Outcome Measures
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Primary Outcome Measures :
  1. Endothelial cell loss [ Time Frame: 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 :
  1. Intra- and post- surgical complications [ Time Frame: 4 month ]
    Diagnosis of Complications in combination with usual follow-up measures

  2. Cumulative dissipated energy (CDE) [ Time Frame: 4 month ]
    Recording of CDE on Phaco device

  3. Ultrasound (US) total time [ Time Frame: 4 month ]
    Record of US Energy applied

  4. Estimated fluid usage (EFU) [ Time Frame: 4 month ]
    Record of EFU

  5. Corneal thickness (CCT) [ Time Frame: 4 month ]
    Mesurement of the Central Corneal Thickness

  6. Uncorrected distance visual acuity (UDVA) [ Time Frame: 4 month ]
    Measurement of UDVA

  7. Corrected distance visual acuity (CDVA) [ Time Frame: 4 month ]
    Measurement of CDVA


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953053


Locations
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Switzerland
Ziemer Ophthalmic Systems AG
Port, Switzerland
Sponsors and Collaborators
Ziemer Ophthalmic Systems AG
Investigators
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Principal Investigator: A-Yong Yu, MD PHD Prof. The Eye Hospital of Wenzhou Medical University
More Information
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Responsible Party: Ziemer Ophthalmic Systems AG
ClinicalTrials.gov Identifier: NCT03953053    
Other Study ID Numbers: FL5940-0001-CN
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: December 27, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Ziemer Ophthalmic Systems AG:
Femto Cataract Surgery
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases