Changes in Prostaglandin Levels in Laser Cataract Surgery (LCS) Subject to Laser Prevalence

Intraindividual Comparison of Prostaglandin E2 (PGE2) and Total-prostaglandin (PG) Following Femtosecond Laser-assisted Cataract Surgery Using a Low-energy, High-frequency Femtosecond Laser-Device in Regard to the Sequence of Anterior Capsulotomy and Lens Fragmentation

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03390400

Acronym

Femto-PG

Enrollment

Registered

2018-01-04

Start date

2017-05-29

Completion date

2018-03-14

Last updated

2018-03-02

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

Brief summary

The investigational device is an approved femtosecond laser (FSL) device with an integrated imaging system to perform certain steps of the cataract procedure. The FSL will perform anterior capsulotomy and lens fragmentation in individuals suffering from age-related cataract with need of cataract surgery. Cataract surgery will be performed in subjects who have signed an informed consent form. Aqueous humor will be collected and screening will be performed for Total Prostaglandin and Prostaglandin E2 via en-bloc Enzyme-linked Immunosorbent Assay (ELISA)-Kit.

Interventions

DEVICEFemtosecondlaser-assisted

Femtosecondlaser-assisted Cataract Surgery will be performed bilateral on the same day with different laser settings.

PROCEDUREAnterior Capsulotomy

Cataract Surgery

PROCEDURELens Fragmentation

Cataract Surgery

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 procedure start.

Intervention model description

Bilateral femtosecond-laser assisted cataract surgery will be performed in individuals with age-related cataract. Eyes will be randomized into two groups receiving either anterior capsulotomy before lens fragmentation or vice versa in the contralateral eye. After laser procedure samples of aqueous humor will be collected and when complete all samples will be analysed by ELISA for Prostaglandin.

Eligibility

Sex/Gender

ALL

Age

40 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Bilateral age-related cataract necessitating phacoemulsification extraction and posterior intraocular lens implantation * Age: 40 to 90 (females of childbearing age will be interviewed if pregnancy is possible) * Preoperative pupil dilation in mydriasis ≥ 6.5 mm

Exclusion criteria

* Preceding ocular surgery or trauma * Recurrent intraocular inflammation of unknown etiology * Uncontrolled glaucoma * Uncontrolled systemic or ocular disease * Blind fellow eye * Microphthalmus * Corneal abnormality * History of uveitis/iritis * Iris neovascularization * Pseudoexfoliation * Proliferative diabetic retinopathy * Pregnancy * Lactation * Females of childbearing age: not included

Design outcomes

Primary

Measure	Time frame	Description
Total-Prostaglandin and PGE2 level in aqueous humor	5 minutes after laser procedure (LCS)	pg/mL

Secondary

Measure	Time frame	Description
Change in Pupilsize	baseline, immediately after laser, 5 min after laser	in mm

Countries

Austria

Outcome results

None listed

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