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

Sponsor

Medical University of Vienna (Other)

Overall Status

Completed

CT.gov ID

NCT03390361

Collaborator

(none)

Enrollment

Location

Arms

7.7

Actual Duration (Months)

5.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Age Related Cataracts	Device: Femtosecond Laser-assisted Procedure: Manual Cataract Surgery	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

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.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:

Triple (Participant, Care Provider, Investigator)

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.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Apr 5, 2016

Actual Primary Completion Date :

Aug 9, 2016

Actual Study Completion Date :

Nov 25, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: LCS Laser cataract surgery will be performed. 5-minutes after LCS aqueous humour will be collected and frozen in -80° celsius.	Device: Femtosecond Laser-assisted Laser cataract surgery will be performed in one eye
Placebo Comparator: MCS Manual cataract surgery will be performed. Aqueous humour will be collected and frozen in -80° celsius before MCS starts.	Procedure: Manual Cataract Surgery Manual cataract surgery will be performed in contralateral eye

Arm

Intervention/Treatment

Active Comparator: LCS

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

Device: Femtosecond Laser-assisted

Laser cataract surgery will be performed in one eye

Placebo Comparator: MCS

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

Procedure: Manual Cataract Surgery

Manual cataract surgery will be performed in contralateral eye

Outcome Measures

Primary Outcome Measures

Proinflammatory cytokines (IL-1β, IL-6) and total-PG [5 minutes after laser procedure]
Interleukin IL-1β, Interleukin IL-6, total-prostaglandin

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

Medical University of Vienna

Investigators

Principal Investigator: Rupert Menapace, MD, Medical University of Vienna

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rupert Menapace, Clinical Professor, Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT03390361

Other Study ID Numbers:

Femto IL + PG Study

First Posted:

Jan 4, 2018

Last Update Posted:

Jan 5, 2018

Last Verified:

Jan 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Rupert Menapace, Clinical Professor, Medical University of Vienna

Laser Cataract Surgery

Prostaglandin

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of Jan 5, 2018