Changes in Prostaglandin Levels in Laser Cataract Surgery (LCS) Subject to Laser Prevalence
NCT03390400 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2018-03-02
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
- Age Related Cataracts
Interventions
- DEVICE
-
Femtosecondlaser-assisted
Femtosecondlaser-assisted Cataract Surgery will be performed bilateral on the same day with different laser settings.
- PROCEDURE
-
Anterior Capsulotomy
Cataract Surgery
- PROCEDURE
-
Lens Fragmentation
Cataract Surgery
Sponsors & Collaborators
-
Rupert Menapace
lead OTHER
Principal Investigators
-
Rupert Menapace, MD · Medical University of Vienna
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 40 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-05-29
- Primary Completion
- 2018-01-02
- Completion
- 2018-03-14
Countries
- Austria
Study Locations
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