Actively Recruiting

Phase 1
Age: 40Years +
All Genders
NCT06754358

Clinical Application Comparison of Two Femtosecond Laser Systems

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2024-12-31

100

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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

CONDITIONS

Official Title

Clinical Application Comparison of Two Femtosecond Laser Systems

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Chinese Han patients aged 40 years or older
  • Clinical diagnosis of age-related cataracts
  • Undergoing femtosecond laser-assisted cataract surgery (FLACS) with insertion of a posterior chamber intraocular lens for the first eye
Not Eligible

You will not qualify if you...

  • Presence of macular diseases such as epiretinal membrane, macular hole, edema, or age-related macular degeneration
  • Poor quality OCT scans
  • Preoperative flare over 15 ph/ms, endothelial cell density less than 2000 cells/mm2, or other corneal diseases
  • Serious ocular diseases including uveitis, uncontrolled glaucoma, optic atrophy, amblyopia, retinopathies, or eye inflammation
  • History of eye trauma, surgery, or retinal laser treatments
  • Use of systemic or topical steroids or NSAIDs within one month before surgery
  • Diabetes or other systemic diseases that may affect study results or increase post-surgery inflammation risk
  • Intraoperative complications such as capsule tear, hyphema, vitreous loss, iris manipulation, or miosis needing epinephrine injection
  • Eye conditions preventing FLACS including poorly dilated pupils (less than 5.0 mm), narrow eye opening, small hyperopic eyes with steep corneas, severe conjunctival chalasis, nystagmus, or lack of cooperation
  • Potential pregnancy
  • Known sensitivity to medications used during the perioperative period
  • Participation in other clinical trials during study visits
  • Poor cooperation in diagnostic tests or follow-up non-compliance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China, 310009

Actively Recruiting

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Research Team

K

Kai Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Clinical Application Comparison of Two Femtosecond Laser Systems | DecenTrialz