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

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06649799
Enrollment
80
Registered
2024-10-21
Start date
2024-08-01
Completion date
2025-06-30
Last updated
2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

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

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.

Interventions

DEVICELenSx

The patients in Group 1 conduct FLACS under LenSx

DEVICEZ8

The patients in Group 1 conducted FLACS using Z8

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PGE2through study completion, an average of half a yearThe concentrations of PGE2 in aqueous humor
cytokines (IL-1β、IL-6, IL-8、TNF-a)through study completion, an average of half a yearThe concentrations of cytokines (IL-1β、IL-6, IL-8、TNF-a) in aqueous humor
MDAthrough study completion, an average of half a yearThe concentrations of MDA in aqueous humor

Secondary

MeasureTime frameDescription
central corneal thicknessthrough study completion, an average of half a yearThe central corneal thickness was measured
central macular thicknessthrough study completion, an average of half a yearThe central macular thickness was measured

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026