NCT06754358 Clinical Application Comparison of Two Femtosecond Laser Systems
| NCT ID | NCT06754358 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Cataract |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-10-29 |
| Primary Completion | 2025-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2024-10-29 with a primary completion date of 2025-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 for checkups and tests Complete clinical measurements and dry eye questionnaires
Eligibility Criteria
Inclusion Criteria: 1. Chinese Han patients aged 40 years or older 2. clinical diagnosis of age-related cataracts; 3. underwent FLACS with insertion of a posterior chamber IOL for the first eye. Exclusion Criteria: 1. 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; 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06754358 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Cataract. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06754358 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06754358 currently recruiting?
Yes, NCT06754358 is actively recruiting participants. Contact the research team at wmzcmxxy@zju.edu.cn for enrollment information.
Where is the NCT06754358 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06754358 clinical trial?
NCT06754358 is sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 100 participants.