Release of Proinflammatory Cytokines (IL-1β, IL-6) and To... | NCT03390361

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 5, 2016Actual

Primary Completion Date

Aug 9, 2016Actual

Completion Date

Nov 25, 2016Actual

First Submitted Date

Dec 28, 2017

First Submission Date that Met QC Criteria

Jan 3, 2018

First Posted Date

Jan 4, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2018

Last Update Posted Date

Jan 5, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Femtosecond Laser-assisted	Device	Laser cataract surgery will be performed in one eye	LCS

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proinflammatory cytokines (IL-1β, IL-6) and total-PG	Interleukin IL-1β, Interleukin IL-6, total-prostaglandin	5 minutes after laser procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rupert Menapace, MD	Medical University of Vienna	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University of Vienna		Vienna		1090	Austria

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.

Intervention 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 Info

Masking

Triple

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.

Who Masked

ParticipantCare ProviderInvestigator