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

NCT06649799 — Not applicable, Enrolling by invitation, 80 participants, Second Affiliated Hospital, Zhejiang University, School of Medicine
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RegistryNCT06649799
StatusEnrolling by invitation
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, health services research
Enrollment80 (Estimated)
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine (Other)
ConditionsCataract
InterventionsLenSx, Z8 (Device)
Datesstart 2024-08-01, primary completion 2025-06-30 (estimated), completion 2025-06-30 (estimated), first posted 2024-10-21, last updated 2024-10-21
Locations1 site in China

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
LenSxExperimentalDevice: LenSx
Z8Placebo comparatorDevice: Z8
  • LenSx (Device): The patients in Group 1 conduct FLACS under LenSx
  • Z8 (Device): The patients in Group 1 conducted FLACS using Z8

+Outcome measures

Primary outcomes

  • PGE2 [through study completion, an average of half a year]: The concentrations of PGE2 in aqueous humor
  • cytokines (IL-1β、IL-6, IL-8、TNF-a) [through study completion, an average of half a year]: The concentrations of cytokines (IL-1β、IL-6, IL-8、TNF-a) in aqueous humor
  • MDA [through study completion, an average of half a year]: The concentrations of MDA in aqueous humor

Secondary outcomes

  • central corneal thickness [through study completion, an average of half a year]: The central corneal thickness was measured
  • central macular thickness [through study completion, an average of half a year]: The central macular thickness was measured

+Eligibility

Sex: All, ages: 50 Years to 80 Years

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

+Locations (1)

FacilityCityCountryStatus
ye Center, The Second Affiliated Hospital, School of Medicine, Zhejiang UniversityHangzhou, ZhejiangChina

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