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

Study Overview
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Brief Summary
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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.

Official Title
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Intraindividual Comparison of Proinflammatory Cytokines (IL-1β, IL-6) and Total-prostaglandin (PG) Following Femtosecond Laser-assisted Cataract Surgery Using a Low-energy, High-frequency Femtosecond Laser-Device Compared to Manual Cataract Surgery

Conditions
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Age Related Cataracts

Intervention / Treatment
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* Device: Femtosecond Laser-assisted
* Procedure: Manual Cataract Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Bilateral age-related cataract necessitating phacoemulsification extraction and posterior intraocular lens implantation. Pupil dilation of ≥ 6.5mm Age 40 and older 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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Patients' eyes will be randomized into two groups receiving either MCS or LCS. In the LCS group aqueous humour will be collected exactly five minutes after laser pretreatment. In the MCS group aqueous humour will be collected before manual manipulation of anterior chamber. Aqueous humour will be screened with Enzyme-linked Immunosorbent Assay (ELISA) Kits for Interleukin-1β; Interleukin-6 and PG.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LCS<br>Laser cataract surgery will be performed. 5-minutes after LCS aqueous humour will be collected and frozen in -80° celsius. | Device: Femtosecond Laser-assisted<br>* Laser cataract surgery will be performed in one eye<br>|
| Placebo Comparator: MCS<br>Manual cataract surgery will be performed. Aqueous humour will be collected and frozen in -80° celsius before MCS starts. | Procedure: Manual Cataract Surgery<br>* Manual cataract surgery will be performed in contralateral eye<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proinflammatory cytokines (IL-1β, IL-6) and total-PG | Interleukin IL-1β, Interleukin IL-6, total-prostaglandin | 5 minutes after laser procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laser Cataract Surgery, Prostaglandin