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

NCT03390361 | Completed DMC

• 1 other identifier: Femto IL + PG Study
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Age Related Cataracts

Keywords

Laser Cataract Surgery; Prostaglandin

Outcome Measures

Primary Outcomes (1)

• Proinflammatory cytokines (IL-1β, IL-6) and total-PG

  Interleukin IL-1β, Interleukin IL-6, total-prostaglandin

  5 minutes after laser procedure

Study Arms (2)

LCS

ACTIVE COMPARATOR

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

Device: Femtosecond Laser-assisted

MCS

PLACEBO COMPARATOR

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

Procedure: Manual Cataract Surgery

Interventions

Femtosecond Laser-assisted DEVICE

Laser cataract surgery will be performed in one eye

LCS

Manual Cataract Surgery PROCEDURE

Manual cataract surgery will be performed in contralateral eye

MCS

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Study Officials

• Rupert Menapace, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 28, 2017
• First Posted: January 4, 2018
• Study Start: April 5, 2016
• Primary Completion: August 9, 2016
• Study Completion: November 25, 2016
• Last Updated: January 5, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)