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OpenTrials
Completed

NCT Number: NCT03390361

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

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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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of Vienna

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Femtosecond Laser-assisted

Device

Laser cataract surgery will be performed in one eye

Manual Cataract Surgery

Procedure

Manual cataract surgery will be performed in contralateral eye

Primary outcomes

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

    Time frame: 5 minutes after laser procedure

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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 4, 2018
Registry last updated
Jan 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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