Comparative Study on Changes in Anterior Chamber Cytokines, Oxidative Stress, and Pupil Size After LenSx and Z8 Femtosecond Lasers

NCT ID: NCT06649799

Last Updated: 2024-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2025-06-30

Brief Summary

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Femtosecond laser-assisted cataract surgery is rapidly gaining popularity. Among the 5 femtosecond laser platforms available at present for cataract surgery, the Femto LDV Z8 (Ziemer Ophthalmic Systems AG) is a high-frequency system and delivers energy pulses in nanojoule levels, while Lensx platform (Lensx, Alcon Laboratories, Inc.) used a high-energy laser system. In femtosecond laser-assisted cataract surgery, the laser pretreatment is associated with breakdown of blood-aqueous barrier (BAB) associated with increased aqueous total prostaglandin, cytokines and Oxygen-free radicals concentration. The prostaglandin rise immediately after laser pretreatment is further thought to be the causative factor for the intraoperative miosis in femtosecond laser-assisted cataract surgery. However, the analysis of anterior chamber inflammatory factors, oxidative stress, and pupil size after femtosecond laser-assisted cataract surgery between different laser platforms has not been investigated in clinical studies. Understanding the cytokine and chemokine changes related to the laser pretreatment provides better insight into the inflammatory response in femtosecond laser-assisted cataract surgery.

Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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LenSx

Group Type EXPERIMENTAL

LenSx

Intervention Type DEVICE

The patients in Group 1 conduct FLACS under LenSx

Z8

Group Type PLACEBO_COMPARATOR

Z8

Intervention Type DEVICE

The patients in Group 1 conducted FLACS using Z8

Interventions

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LenSx

The patients in Group 1 conduct FLACS under LenSx

Intervention Type DEVICE

Z8

The patients in Group 1 conducted FLACS using Z8

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Age related cataracts over 50 years old, nuclear grades II-III

Exclusion Criteria

* Eye diseases: glaucoma, uveitis

* Systemic diseases: autoimmune diseases such as diabetes and rheumatism ③ Intraoperative complications: ④ Medication history: Over 1 month before surgery, systemic or local hormones, NASIDs ⑤ History of eye surgery (including YAG laser and fundus laser), trauma
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ye Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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2022-0672

Identifier Type: -

Identifier Source: org_study_id

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