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

NCT06649799 | Enrolling By Invitation DMC

• 1 other identifier: 2022-0672
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract

Keywords

cataract; femtosecond laser; cytokines; oxidative stress; miosis;

Outcome Measures

Primary Outcomes (3)

• PGE2

  The concentrations of PGE2 in aqueous humor

  through study completion, an average of half a year

• cytokines (IL-1β、IL-6, IL-8、TNF-a)

  The concentrations of cytokines (IL-1β、IL-6, IL-8、TNF-a) in aqueous humor

  through study completion, an average of half a year

• MDA

  The concentrations of MDA in aqueous humor

  through study completion, an average of half a year

Secondary Outcomes (2)

• central corneal thickness

  through study completion, an average of half a year

• central macular thickness

  through study completion, an average of half a year

Study Arms (2)

LenSx

EXPERIMENTAL

Device: LenSx

Z8

PLACEBO COMPARATOR

Device: Z8

Interventions

LenSx DEVICE

The patients in Group 1 conduct FLACS under LenSx

LenSx

Z8 DEVICE

The patients in Group 1 conducted FLACS using Z8

Z8

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

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

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Cataract; Miosis

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Pupil Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 21, 2024
• Study Start: August 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)