Comparing two femtosecond laser systems for cataract surgery

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

This study is testing two different laser systems for cataract surgery to see which one works better for people aged 40 and older with age-related cataracts.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06754358 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the perioperative parameters of femtosecond laser-assisted cataract surgery (FLACS) using two different laser systems: LenSx and Z8. Participants will undergo FLACS with the insertion of a posterior chamber intraocular lens (IOL) and will be monitored through preoperative and postoperative checkups at one day, one week, and one month. Clinical measurements and dry eye questionnaires will also be completed to assess outcomes. The study focuses on Chinese Han patients aged 40 years or older diagnosed with age-related cataracts.

Who should consider this trial

Good fit: Ideal candidates for this study are Chinese Han patients aged 40 years or older with a clinical diagnosis of age-related cataracts.

Not a fit: Patients with coexisting serious ocular diseases or systemic conditions that may complicate surgery or recovery will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the precision and outcomes of cataract surgery, leading to improved vision restoration for patients.

How similar studies have performed: Other studies have shown success with femtosecond laser-assisted cataract surgery, indicating that this approach is well-established in the field.

Eligibility criteria

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.

Where this trial is running

Hangzhou, Zhejiang

• Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Kai Wang

Conditions Cataract