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Enrolling by Invitation

NCT Number: NCT06649799

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

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.

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Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hangzhou, Zhejiang, 310000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LenSx

Device

The patients in Group 1 conduct FLACS under LenSx

Z8

Device

The patients in Group 1 conducted FLACS using Z8

Primary outcomes

  1. PGE2

    Time frame: through study completion, an average of half a year

    The concentrations of PGE2 in aqueous humor

  2. cytokines (IL-1β、IL-6, IL-8、TNF-a)

    Time frame: through study completion, an average of half a year

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

  3. MDA

    Time frame: through study completion, an average of half a year

    The concentrations of MDA in aqueous humor

Secondary outcomes

  1. central corneal thickness

    Time frame: through study completion, an average of half a year

    The central corneal thickness was measured

  2. central macular thickness

    Time frame: through study completion, an average of half a year

    The central macular thickness was measured

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 21, 2024
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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