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Clinical Application Comparison of Two Femtosecond Laser Systems

Clinical Application Comparison of Two Femtosecond Laser Systems

Recruiting
40 years and older
All
Phase 1

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Overview

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

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.

Study details
    Cataract

NCT06754358

Second Affiliated Hospital, School of Medicine, Zhejiang University

11 January 2025

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