CataractZ8CAT01NCT03953053
Safety and Efficacy of FLACS With the FEMTO LDV Z8 Laser Compared to Conventional Cataract Surgery in Chinese Patients
A study testing Femtosecond Laser Assissted Cataract Surgery in people with Cataract, run by Ziemer Ophthalmic Systems AG at 1 site in Switzerland.
Trial 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 more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Cataract
- What is being tested?
- Femtosecond Laser Assissted Cataract Surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Jun 2019to 4 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cataract
- Being tested
- Femtosecond Laser Assissted Cataract Surgery
- Keywords
- Femto Cataract Surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femtosecond Laser Assissted Cataract SurgeryDevice
During routine Catarct Surgery the Femtolaser cuts a ACCC (Anterior Continous Curvilinear Capsulotomy) into the lensbag and fragmentise the cataract affilited lens body
| Study group | Role | What they receive |
|---|---|---|
| FLACS Group | Experimental | Femto Laser treated (anterior Capsulotomy and Fragmentation of lens body before phaco emulification) Receives: Device: Femtosecond Laser Assissted Cataract Surgery |
| Manual Group | Active comparator | Gold Standard Method with manual rhexis with pinzette and phaco emulsification Receives: Device: Femtosecond Laser Assissted Cataract Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 month
Secondary outcomes (7)
Intra- and post- surgical complications
Diagnosis of Complications in combination with usual follow-up measures
Measured: 4 month
Cumulative dissipated energy (CDE)
Recording of CDE on Phaco device
Measured: 4 month
Ultrasound (US) total time
Record of US Energy applied
Measured: 4 month
Estimated fluid usage (EFU)
Record of EFU
Measured: 4 month
Corneal thickness (CCT)
Mesurement of the Central Corneal Thickness
Measured: 4 month
Uncorrected distance visual acuity (UDVA)
Measurement of UDVA
Measured: 4 month
Corrected distance visual acuity (CDVA)
Measurement of CDVA
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start3 Jun 2019
- Primary completion4 Jun 2020
- Study completion4 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziemer Ophthalmic Systems AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- A-Yong Yu, MD PHD Prof., Principal investigator, The Eye Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03953053
- Sponsor's protocol ID
- FL5940-0001-CN
- Acronym
- Z8CAT01
- Status last verified
- Dec 2021
- First submitted
- 15 May 2019
- Last updated
- 27 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37393278
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of FLACS With the FEMTO LDV Z8 Laser Compared to Conventional Cataract Surgery in Chinese Patients
- ClinicalTrials.gov ID
- NCT03953053
- Acronym / sponsor ID
- Z8CAT01 / FL5940-0001-CN
- Conditions
- Cataract
- Keywords
- Femto Cataract Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Ziemer Ophthalmic Systems AGIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 4 Jun 2020 (actual)
- Study completion
- 4 Jun 2020 (actual)
- First posted
- 16 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FLACS Group | Experimental | Device: Femtosecond Laser Assissted Cataract SurgeryFemto Laser treated (anterior Capsulotomy and Fragmentation of lens body before phaco emulification) |
| Manual Group | Active comparator | Device: Femtosecond Laser Assissted Cataract SurgeryGold Standard Method with manual rhexis with pinzette and phaco emulsification |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Femtosecond Laser Assissted Cataract SurgeryDuring routine Catarct Surgery the Femtolaser cuts a ACCC (Anterior Continous Curvilinear Capsulotomy) into the lensbag and fragmentise the cataract affilited lens body | Device | FLACS Group, Manual Group |
Primary outcome
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
7 secondary outcomes
Intra- and post- surgical complications
Time frame: 4 month
Cumulative dissipated energy (CDE)
Time frame: 4 month
Ultrasound (US) total time
Time frame: 4 month
Estimated fluid usage (EFU)
Time frame: 4 month
Corneal thickness (CCT)
Time frame: 4 month
Uncorrected distance visual acuity (UDVA)
Time frame: 4 month
Corrected distance visual acuity (CDVA)
Time frame: 4 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2021.
- Derived from this study: PubMed 37393278Zhou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A-Yong Yu, MD PHD Prof. principal investigator
The Eye Hospital of Wenzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femtosecond Laser Assissted Cataract Surgery in people with Cataract, run by Ziemer Ophthalmic Systems AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial cell loss (time frame: 4 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03953053, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2021; AzTrials last refreshed its copy on 8 Nov 2026.