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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03390361

Enrollment

Registered

2018-01-04

Start date

2016-04-05

Completion date

2016-11-25

Last updated

2018-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age Related Cataracts

Keywords

Laser Cataract Surgery, Prostaglandin

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.

Interventions

DEVICEFemtosecond Laser-assisted

Laser cataract surgery will be performed in one eye

PROCEDUREManual Cataract Surgery

Manual cataract surgery will be performed in contralateral eye

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, 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.

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.

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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

Design outcomes

Primary

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

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026