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

Primary Purpose

Age Related Cataracts

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Femtosecond Laser-assisted
Manual Cataract Surgery
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Related Cataracts focused on measuring Laser Cataract Surgery, Prostaglandin

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

LCS

MCS

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 28, 2017
Last Updated
January 4, 2018
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT03390361
Brief Title
Release of Proinflammatory Cytokines (IL-1β, IL-6) and Total-prostaglandin (PG) Following Femtosecond Laser-assisted Cataract Surgery Compared to Manual Cataract Surgery
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
April 5, 2016 (Actual)
Primary Completion Date
August 9, 2016 (Actual)
Study Completion Date
November 25, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Cataracts
Keywords
Laser Cataract Surgery, Prostaglandin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
ParticipantCare ProviderInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LCS
Arm Type
Active Comparator
Arm Description
Laser cataract surgery will be performed. 5-minutes after LCS aqueous humour will be collected and frozen in -80° celsius.
Arm Title
MCS
Arm Type
Placebo Comparator
Arm Description
Manual cataract surgery will be performed. Aqueous humour will be collected and frozen in -80° celsius before MCS starts.
Intervention Type
Device
Intervention Name(s)
Femtosecond Laser-assisted
Intervention Description
Laser cataract surgery will be performed in one eye
Intervention Type
Procedure
Intervention Name(s)
Manual Cataract Surgery
Intervention Description
Manual cataract surgery will be performed in contralateral eye
Primary Outcome Measure Information:
Title
Proinflammatory cytokines (IL-1β, IL-6) and total-PG
Description
Interleukin IL-1β, Interleukin IL-6, total-prostaglandin
Time Frame
5 minutes after laser procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rupert Menapace, MD
Organizational Affiliation
Medical University of Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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