CataractPhase 1NCT06754358
Clinical Application Comparison of Two Femtosecond Laser Systems
A Phase 1 study testing LenSx and Z8 in people with Cataract, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this clinical trial is to compare the perioperative parameters of femtosecond laser-assisted cataract surgery (FLACS) using two laser systems. Participants will: Undergo FLACS using LenSx or Z8 femtosecond laser system Visit the clinic before the operation and 1 day, 1 week, and 1 month after the operation… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- LenSx and Z8
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 29 Oct 2024to 31 Oct 2025
- Phase
- Phase 1
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese Han patients aged 40 years or older
- clinical diagnosis of age-related cataracts;
- underwent FLACS with insertion of a posterior chamber IOL for the first eye.
Who cannot join
- coexisting macular pathologies such as epiretinal membrane, macular hole or edema, or age-related macular degeneration. Patients with OCT scans of poor quality were excluded;
- preoperative flare of more than 15ph/ms11, ECD<2000cells/mm2 or any other corneal pathologies;
- coexisting serious ocular diseases including uveitis, uncontrolled glaucoma, optic atrophy , amblyopia, retinopathies, or inflammatory pathology of the eye;
- history of intraocular trauma, surgery, or retinal laser procedures;
- usage of systemic or topical steroids or NSAIDs within one month prior to surgery;
- patients with diabetes or any other systemic diseases that might confound the results or increase the risk for postoperative inflammation;
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- intraoperative complications such as capsule tear, hyphema, vitreous loss, iris manipulation, or miosis after laser pre treatment requiring intracameral injection of epinephrine;
- ocular conditions contraindicating FLACS including poorly dilated pupils (<5.0mm), narrow palpebral fissure, small hyperopic eyes with steep cornea (difficult to achieve suction), severe conjunctival chalasis, nystagmus, or lack of cooperation;
- potentially pregnant women;
- known sensitivity to concomitant medications used during perioperative period, participation in other clinical trial during the time of visit, or poor cooperation in diagnostic tests or non-compliance at follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310009
Kai Wang, +86 57187783897, wmzcmxxy@zju.edu.cn
About this study
Official title: Comparison of Perioperative Parameters of Femtosecond Laser-assisted Cataract Surgery Using Two Laser Systems: a Randomized Clinical Trial
The goal of this clinical trial is to compare the perioperative parameters of femtosecond laser-assisted cataract surgery (FLACS) using two laser systems.
Participants will:
Undergo FLACS using LenSx or Z8 femtosecond laser system Visit the clinic before the operation and 1 day, 1 week, and 1 month after the operation for checkups and tests Complete clinical measurements and dry eye questionnaires
- Conditions
- Cataract
- Being tested
- LenSx, Z8
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenSxProcedure or surgery
Participants undergo FLACS using LenSx femtosecond laser system
Z8Procedure or surgery
Participants undergo FLACS using Z8 femtosecond laser system
| Study group | Role | What they receive |
|---|---|---|
| LenSx group | Active comparator | Not described Receives: Procedure: LenSx |
| Z8 group | Experimental | Not described Receives: Procedure: Z8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ocular staining score
The ocular staining score ranged from 0 to 12. A score of 0 indicated no corneal or conjunctival staining with fluorescein or lissamine green dye, respectively. A score of 12 indicated severe staining of the cornea and conjunctiva with confluent and central fluorescein staining, the presence of corneal filaments, and confluent areas of lissamine green of the bulbar conjunctiva of greater than or equal to 4 mm2.
Measured: 1 month after operation
Secondary outcomes (17)
ocular staining score
The ocular staining score ranged from 0 to 12. A score of 0 indicated no corneal or conjunctival staining with fluorescein or lissamine green dye, respectively. A score of 12 indicated severe staining of the cornea and conjunctiva with confluent and central fluorescein staining, the presence of corneal filaments, and confluent areas of lissamine green of the bulbar conjunctiva of greater than or equal to 4 mm2.
Measured: 1 day and 1 week after operation
phacoemulsification time
Measured: in the operation
ultrasound power
Measured: in the operation
vacuum docking time
Measured: in the operation
femtosecond laser emission time
Measured: in the operation
femtosecond laser-assisted capsulorhexis time
Measured: in the operation
femtosecond laser-assisted pre-chop time
Measured: in the operation
surgical time
Measured: in the operation
surgical complication
Measured: in the operation
DEQ-5 questionnaire
The dry-eye questionnaire-5 (DEQ-5) is a validated questionnaire that has been shown to discriminate between different severities of dry eye. Participants self-assessed the frequency and severity of eye discomfort, eye dryness, and watery eyes experienced during the evening of a typical day within the last month. Responses were given using a Likert scale with scoring criteria from 0 = never experienced the symptom to 5 = extremely severe experience of symptom. The sum of the scores from the five questions was used in the analysis.
Measured: 1 week and 1 month after the operation
OSDI questionnaire
Ocular surface disease index (OSDI) is a widely accepted questionnaire on subjective symptoms in patients with dry eyes. It consisted of 12 questions on eye-related symptoms, vision-related function, and environment-related symptoms. Each question is evaluated according to the frequency of occurrence: never, 0 point; occasionally, 1 point; often, 2 points; most of the time, 3 points; all the time, 4 points. Not all the 12 questions needed to be answered. If the question is that the patient didn't participate in the activity or the environment that would not be in the case, it would not be answered and scored. The final score is calculated according to the formula: OSDI values=(sum of all survey items)×100/(answered survey items)×4.
Measured: 1 week and 1 month after the operation
tear meniscus height
The tear meniscus assessment height was measured with the Ocular Surface Analyser (SBM Sistemi, Orbassano, Italy)
Measured: 1 day, 1 week, and 1 month after the operation
noninvasive tear film breakup time
Noninvasive tear film breakup time was assessed automatically using the Ocular Surface Analyser (SBM Sistemi, Orbassano, Italy). The participants were instructed to blink naturally two times and then to cease blinking until instructed to blink again. Three measurements were performed for each eye and the average for each eye included for analysis.
Measured: 1 day, 1 week, and 1 month after the operation
tear-film assessment
The tear-film assessment was assessed with the Ocular Surface Analyser (SBM Sistemi, Orbassano, Italy).
Measured: 1 day, 1 week, and 1 month after the operation
Schirmer I test
The Schirmer I test was carried out under natural light. A 5 mm×35 mm Schirmer test strip was placed in the middle and outer 1/3 junction of the lower conjunctival sac of the affected eye without anesthesia. The patient was asked to close eyes gently. After 5min, the strip was removed and the wet length of the strip was measured. Values less than 5 mm are indicators for dry eye syndrome.
Measured: 1 day, 1 week, and 1 month after the operation
visual acuity
Measured: 1 day, 1 week, and 1 month after the operation
intraocular pressure
Measured: 1 day, 1 week, and 1 month after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start29 Oct 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754358
- Sponsor's protocol ID
- 2024-1312
- Status last verified
- Oct 2024
- First submitted
- 15 Dec 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Perioperative Parameters of Femtosecond Laser-assisted Cataract Surgery Using Two Laser Systems: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06754358
- Acronym / sponsor ID
- 2024-1312
- Conditions
- Cataract
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 31 Dec 2024 (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.
The goal of this clinical trial is to compare the perioperative parameters of femtosecond laser-assisted cataract surgery (FLACS) using two laser systems.
Participants will:
Undergo FLACS using LenSx or Z8 femtosecond laser system Visit the clinic before the operation and 1 day, 1 week, and 1 month after the operation for checkups and tests Complete clinical measurements and dry eye questionnaires
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LenSx group | Active comparator | Procedure: LenSx |
| Z8 group | Experimental | Procedure: Z8 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chinese Han patients aged 40 years or older
- clinical diagnosis of age-related cataracts;
- underwent FLACS with insertion of a posterior chamber IOL for the first eye.
Key exclusion criteria (10 listed)
- coexisting macular pathologies such as epiretinal membrane, macular hole or edema, or age-related macular degeneration. Patients with OCT scans of poor quality were excluded;
- preoperative flare of more than 15ph/ms11, ECD<2000cells/mm2 or any other corneal pathologies;
- coexisting serious ocular diseases including uveitis, uncontrolled glaucoma, optic atrophy , amblyopia, retinopathies, or inflammatory pathology of the eye;
- history of intraocular trauma, surgery, or retinal laser procedures;
- usage of systemic or topical steroids or NSAIDs within one month prior to surgery;
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 |
|---|---|---|
| LenSxParticipants undergo FLACS using LenSx femtosecond laser system | Procedure or surgery | LenSx group |
| Z8Participants undergo FLACS using Z8 femtosecond laser system | Procedure or surgery | Z8 group |
Primary outcome
ocular staining score
Time frame: 1 month after operation
The ocular staining score ranged from 0 to 12. A score of 0 indicated no corneal or conjunctival staining with fluorescein or lissamine green dye, respectively. A score of 12 indicated severe staining of the cornea and conjunctiva with confluent and central fluorescein staining, the presence of corneal filaments, and confluent areas of lissamine green of the bulbar conjunctiva of greater than or equal to 4 mm2.
17 secondary outcomes
ocular staining score
Time frame: 1 day and 1 week after operation
phacoemulsification time
Time frame: in the operation
ultrasound power
Time frame: in the operation
vacuum docking time
Time frame: in the operation
femtosecond laser emission time
Time frame: in the operation
femtosecond laser-assisted capsulorhexis time
Time frame: in the operation
femtosecond laser-assisted pre-chop time
Time frame: in the operation
surgical time
Time frame: in the operation
surgical complication
Time frame: in the operation
DEQ-5 questionnaire
Time frame: 1 week and 1 month after the operation
OSDI questionnaire
Time frame: 1 week and 1 month after the operation
tear meniscus height
Time frame: 1 day, 1 week, and 1 month after the operation
noninvasive tear film breakup time
Time frame: 1 day, 1 week, and 1 month after the operation
tear-film assessment
Time frame: 1 day, 1 week, and 1 month after the operation
Schirmer I test
Time frame: 1 day, 1 week, and 1 month after the operation
visual acuity
Time frame: 1 day, 1 week, and 1 month after the operation
intraocular pressure
Time frame: 1 day, 1 week, and 1 month after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LenSx and Z8 in people with Cataract, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 31 Dec 2024. 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 China. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai Wang (+86 57187783897, wmzcmxxy@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ocular staining score (time frame: 1 month after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2024.