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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-05

Study Completion Date

2016-11-25

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.

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Detailed Description

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Conditions

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Age Related Cataracts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Groups will be randomized. Randomization information will be put in a sealed envelope on screening date and opened in operating theatre right before the surgery.

Study Groups

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LCS

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

Group Type ACTIVE_COMPARATOR

Femtosecond Laser-assisted

Intervention Type DEVICE

Laser cataract surgery will be performed in one eye

MCS

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

Group Type PLACEBO_COMPARATOR

Manual Cataract Surgery

Intervention Type PROCEDURE

Manual cataract surgery will be performed in contralateral eye

Interventions

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Femtosecond Laser-assisted

Laser cataract surgery will be performed in one eye

Intervention Type DEVICE

Manual Cataract Surgery

Manual cataract surgery will be performed in contralateral eye

Intervention Type PROCEDURE

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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes