RecruitingPhase 1NCT06754358

Clinical Application Comparison of Two Femtosecond Laser Systems

Comparison of Perioperative Parameters of Femtosecond Laser-assisted Cataract Surgery Using Two Laser Systems: a Randomized Clinical Trial

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

100 participants

Start Date

Oct 29, 2024

Study Type

INTERVENTIONAL

Conditions

Cataract

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

Min Age: 40 Years

Inclusion Criteria3

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.

Exclusion Criteria10

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;
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.