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

Rupert Menapace

Status: Unknown

Conditions: Age Related Cataracts

Treatments: Device: Femtosecondlaser-assisted; Procedure: Lens Fragmentation; Procedure: Anterior Capsulotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03390400

Femto-PGII Study

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 40 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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70 participants in 2 patient groups

Anterior Capsulotomy before Lens Fragmentation

Active Comparator group

Description:

Anterior capsulotomy will be performed by femtosecond laser before lens fragmentation

Treatment:

Procedure: Anterior Capsulotomy

Device: Femtosecondlaser-assisted

Lens Fragmentation before Anterior Capsulotomy

Active Comparator group

Description:

Lens fragmentation will be performed by femtosecond laser before anterior capsulotomy

Treatment:

Procedure: Lens Fragmentation

Device: Femtosecondlaser-assisted