Clinical Application Comparison of Two Femtosecond Laser Systems

NCT06754358 | Recruiting Phase 1

• 1 other identifier: 2024-1312
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cataract

Outcome Measures

Primary Outcomes (1)

• ocular staining score

  The ocular staining score ranged from 0 to 12. A score of 0 indicated no corneal or conjunctival staining with fluorescein or lissamine green dye, respectively. A score of 12 indicated severe staining of the cornea and conjunctiva with confluent and central fluorescein staining, the presence of corneal filaments, and confluent areas of lissamine green of the bulbar conjunctiva of greater than or equal to 4 mm2.

  1 month after operation

Secondary Outcomes (17)

• ocular staining score

  1 day and 1 week after operation

• phacoemulsification time

  in the operation

• ultrasound power

  in the operation

• vacuum docking time

  in the operation

• femtosecond laser emission time

  in the operation

Study Arms (2)

LenSx group

ACTIVE COMPARATOR

Procedure: LenSx

Z8 group

EXPERIMENTAL

Procedure: Z8

Interventions

LenSx PROCEDURE

Participants undergo FLACS using LenSx femtosecond laser system

LenSx group

Z8 PROCEDURE

Participants undergo FLACS using Z8 femtosecond laser system

Z8 group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Central Study Contacts

Kai Wang

CONTACT

+86 57187783897; wmzcmxxy@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: December 31, 2024
• Study Start: October 29, 2024
• Primary Completion: August 31, 2025
• Study Completion: October 31, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-10

Locations

CN (1)