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Recruiting NCT06754358

Clinical Application Comparison of Two Femtosecond Laser Systems

Phase I Interventional Cataract

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LenSx, Z8.
Who it may be relevant to
Registry conditions: Cataract. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

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

Interventions

  • Procedure LenSx
    Participants undergo FLACS using LenSx femtosecond laser system
  • Procedure Z8
    Participants undergo FLACS using Z8 femtosecond laser system

Primary outcome measures

  • ocular staining score [Time frame: 1 month after operation]
Secondary outcome measures (12)
  • ocular staining score [Time frame: 1 day and 1 week after operation]
  • phacoemulsification time [Time frame: in the operation]
  • ultrasound power [Time frame: in the operation]
  • vacuum docking time [Time frame: in the operation]
  • femtosecond laser emission time [Time frame: in the operation]
  • femtosecond laser-assisted capsulorhexis time [Time frame: in the operation]
  • femtosecond laser-assisted pre-chop time [Time frame: in the operation]
  • surgical time [Time frame: in the operation]
  • surgical complication [Time frame: in the operation]
  • DEQ-5 questionnaire [Time frame: 1 week and 1 month after the operation]
  • OSDI questionnaire [Time frame: 1 week and 1 month after the operation]
  • tear meniscus height [Time frame: 1 day, 1 week, and 1 month after the operation]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou

Identifiers

NCT: NCT06754358 · 2024-1312

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗