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

Medical University of Vienna

Status: Completed

Conditions: Age Related Cataracts

Treatments: Procedure: Manual Cataract Surgery; Device: Femtosecond Laser-assisted

Study type: Interventional

Funder types: Other

Identifiers

NCT03390361

Femto IL + PG Study

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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40 participants in 2 patient groups, including a placebo group

LCS

Active Comparator group

Description:

Laser cataract surgery will be performed. 5-minutes after LCS aqueous humour will be collected and frozen in -80° celsius.

Treatment:

Device: Femtosecond Laser-assisted

MCS

Placebo Comparator group

Description:

Manual cataract surgery will be performed. Aqueous humour will be collected and frozen in -80° celsius before MCS starts.

Treatment:

Procedure: Manual Cataract Surgery