Clinical Application Comparison of Two Femtosecond Laser Systems
NCT ID: NCT06754358
Last Updated: 2024-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
100 participants
INTERVENTIONAL
2024-10-29
2025-10-31
Brief Summary
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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
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LenSx group
LenSx
Participants undergo FLACS using LenSx femtosecond laser system
Z8 group
Z8
Participants undergo FLACS using Z8 femtosecond laser system
Interventions
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LenSx
Participants undergo FLACS using LenSx femtosecond laser system
Z8
Participants undergo FLACS using Z8 femtosecond laser system
Eligibility Criteria
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Inclusion Criteria
2. clinical diagnosis of age-related cataracts;
3. underwent FLACS with insertion of a posterior chamber IOL for the first eye.
Exclusion Criteria
2. preoperative flare of more than 15ph/ms11, ECD\<2000cells/mm2 or any other corneal pathologies;
3. coexisting serious ocular diseases including uveitis, uncontrolled glaucoma, optic atrophy , amblyopia, retinopathies, or inflammatory pathology of the eye;
4. history of intraocular trauma, surgery, or retinal laser procedures;
5. usage of systemic or topical steroids or NSAIDs within one month prior to surgery;
6. patients with diabetes or any other systemic diseases that might confound the results or increase the risk for postoperative inflammation;
7. intraoperative complications such as capsule tear, hyphema, vitreous loss, iris manipulation, or miosis after laser pre treatment requiring intracameral injection of epinephrine;
8. 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;
9. potentially pregnant women;
10. 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.
40 Years
ALL
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Locations
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Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Kai Wang
Role: primary
Other Identifiers
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2024-1312
Identifier Type: -
Identifier Source: org_study_id