Release of Proinflammatory Cytokines (IL-1β, IL-6) and Total-prostaglandin (PG) Following Femtosecond Laser-assisted Cataract Surgery Compared to Manual Cataract Surgery

Not Applicable

Completed

• Conditions: Age Related Cataracts
• Interventions: Device: Femtosecond Laser-assisted; Procedure: Manual Cataract Surgery

• Registration Number: NCT03390361
• Lead Sponsor: Medical University of Vienna

Brief Summary

Patients with bilateral age related cataract will be included in the study. Manual cataract surgery (MCS) will be performed in one eye and laser cataract surgery (LCS) in the corresponding eye. LCS will be performed with an approved femtosecond laser (FSL) device with an integrated imaging system.

After surgery aqueous humour will be collected and screened with Enzyme-linked Immunosorbent Assay (ELISA) Kits for Interleukin-1β; Interleukin-6 and PG.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-05
• Primary Completion: 2016-08-09
• Study Completion: 2016-11-25
• Study First Submitted: 2017-12-28
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-03
• Study First Posted: 2018-01-04
• Last Update Submitted: 2018-01-04
• Last Update Posted: 2018-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Bilateral age-related cataract necessitating phacoemulsification extraction and posterior intraocular lens implantation.
• Pupil dilation of ≥ 6.5mm
• Age 40 and older

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Exclusion Criteria

• Corneal abnormality
• Pseudoexfoliation
• Preceding ocular surgery or trauma
• Uncontrolled glaucoma
• Proliferative diabetic retinopathy
• Iris neovascularization
• History of uveitis/iritis
• Microphthalmus
• Recurrent intraocular inflammation of unknown etiology
• Blind fellow eye
• Uncontrolled systemic or ocular disease
• Pregnancy
• Lactation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LCS	Femtosecond Laser-assisted	Laser cataract surgery will be performed. 5-minutes after LCS aqueous humour will be collected and frozen in -80° celsius.
MCS	Manual Cataract Surgery	Manual cataract surgery will be performed. Aqueous humour will be collected and frozen in -80° celsius before MCS starts.

Primary Outcome Measures

Name	Time	Method
Proinflammatory cytokines (IL-1β, IL-6) and total-PG	5 minutes after laser procedure	Interleukin IL-1β, Interleukin IL-6, total-prostaglandin

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria