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

Age Related Cataracts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03390361
• Other study ID #: Femto IL + PG Study
• Status: Completed
• Phase: N/A
• First received: December 28, 2017
• Last updated: January 4, 2018
• Start date: April 5, 2016
• Est. completion date: November 25, 2016

Study information

• Verified date: January 2018
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 25, 2016
• Est. primary completion date: August 9, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age Related Cataracts
• Cataract

Intervention

Device:
• Femtosecond Laser-assisted
Laser cataract surgery will be performed in one eye

Procedure:
• Manual Cataract Surgery
Manual cataract surgery will be performed in contralateral eye

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proinflammatory cytokines (IL-1ß, IL-6) and total-PG	Interleukin IL-1ß, Interleukin IL-6, total-prostaglandin	5 minutes after laser procedure