Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03953053
Recruitment Status : Not yet recruiting
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Ziemer Ophthalmic Systems AG

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
Safety and Efficacy of the FEMTO LDV Z8 Laser for Cataract Surgery in a Chinese Population 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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


Contacts
Layout table for location contacts
Contact: Olga Grossenbacher, MD 0041 79 671 6725 olga.grossenbacher@ziemergroup.com
Contact: Nikolaus T Kaiser, Dipl.-Ing 0041799180588 nikolaus.kaiser@ziemergroup.com

Locations
Layout table for location information
Switzerland
Ziemer Ophthalmic Systems AG
Port, Switzerland
Sponsors and Collaborators
Ziemer Ophthalmic Systems AG
Investigators
Layout table for investigator information
Principal Investigator: A-Yong Yu, MD PHD Prof. The Eye Hospital of Wenzhou Medical University

Layout table for additonal information
Responsible Party: Ziemer Ophthalmic Systems AG
ClinicalTrials.gov Identifier: NCT03953053     History of Changes
Other Study ID Numbers: FL5940-0001-CN
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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

Additional relevant MeSH terms:
Layout table for MeSH terms
Cataract
Lens Diseases
Eye Diseases