Clinical Application Comparison of Two Femtosecond Laser Systems

Zhejiang University

Status and phase

Enrolling

Phase 1

Conditions

Cataract

Treatments

Procedure: Z8

Procedure: LenSx

Study type

Interventional

Funder types

Other

Identifiers

NCT06754358

2024-1312

Details and patient eligibility

About

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

Enrollment

100 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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.