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CompletedNCT03953053Z8CAT01Updated Dec 27, 2021

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

An interventional study of Femtosecond Laser Assissted Cataract Surgery in Cataract, sponsored by Ziemer Ophthalmic Systems AG. Completed at 1 site in Switzerland. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-12-27.

Sponsored by Ziemer Ophthalmic Systems AG · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Cataract

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Keywords

  • Femto Cataract Surgery
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In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 132 is above the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Ziemer Ophthalmic Systems AG is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
132 participants (actual)

Study arms

  • Experimental
    FLACS Group

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

    Device: Femtosecond Laser Assissted Cataract Surgery

  • Active comparator
    Manual Group

    Gold Standard Method with manual rhexis with pinzette and phaco emulsification

    Device: Femtosecond Laser Assissted Cataract Surgery

Interventions

  • DeviceFemtosecond 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

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What researchers measure

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

    Time frame: 4 month

Secondary outcomes

  1. Intra- and post- surgical complications

    Diagnosis of Complications in combination with usual follow-up measures

    Time frame: 4 month

  2. Cumulative dissipated energy (CDE)

    Recording of CDE on Phaco device

    Time frame: 4 month

  3. Ultrasound (US) total time

    Record of US Energy applied

    Time frame: 4 month

  4. Estimated fluid usage (EFU)

    Record of EFU

    Time frame: 4 month

  5. Corneal thickness (CCT)

    Mesurement of the Central Corneal Thickness

    Time frame: 4 month

  6. Uncorrected distance visual acuity (UDVA)

    Measurement of UDVA

    Time frame: 4 month

  7. Corrected distance visual acuity (CDVA)

    Measurement of CDVA

    Time frame: 4 month

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Study locations

1 site
  • Ziemer Ophthalmic Systems AG
    Port, Switzerland
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03953053
Lead sponsor
Ziemer Ophthalmic Systems AG
Responsible party
Sponsor
First posted
May 16, 2019
Start date
Jun 3, 2019
Primary completion
Jun 4, 2020
Completion
Jun 4, 2020
Last update
Dec 27, 2021

Study contacts

A-Yong Yu, MD PHD Prof.
principal investigator · The Eye Hospital of Wenzhou Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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