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

Rupert Menapace70 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Age Related Cataracts

Interventions

Femtosecondlaser-assistedDEVICE

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

Anterior CapsulotomyPROCEDURE

Cataract Surgery

Lens FragmentationPROCEDURE

Cataract Surgery

Eligibility

Sex: ALLMin age: 40 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical University of Vienna

Vienna, Austria

Outcomes

Primary Outcomes

Total-Prostaglandin and PGE2 level in aqueous humor

pg/mL

Time frame: 5 minutes after laser procedure (LCS)

Secondary Outcomes

Change in Pupilsize

in mm

Time frame: baseline, immediately after laser, 5 min after laser

Data from ClinicalTrials.gov

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