Clinical Trials Directory

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UnknownNCT03390400

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
Phase
N/A
Study type
Interventional
Enrollment
70 (actual)
Sponsor
Rupert Menapace · Academic / Other
Sex
All
Age
40 Years – 90 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEFemtosecondlaser-assistedFemtosecondlaser-assisted Cataract Surgery will be performed bilateral on the same day with different laser settings.
PROCEDUREAnterior CapsulotomyCataract Surgery
PROCEDURELens FragmentationCataract Surgery

Timeline

Start date
2017-05-29
Primary completion
2018-01-02
Completion
2018-03-14
First posted
2018-01-04
Last updated
2018-03-02

Locations

1 site across 1 country: Austria

Source: ClinicalTrials.gov record NCT03390400. Inclusion in this directory is not an endorsement.