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

Age Related Cataracts Clinical Trial

— Femto-PG  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03390400
• Other study ID #: Femto-PGII Study
• Status: Active, not recruiting
• Phase: N/A
• First received: December 28, 2017
• Last updated: March 1, 2018
• Start date: May 29, 2017
• Est. completion date: March 14, 2018

Study information

• Verified date: March 2018
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: March 14, 2018
• Est. primary completion date: January 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Age Related Cataracts
• Cataract

Intervention

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

Procedure:
• Anterior Capsulotomy
Cataract Surgery
• Lens Fragmentation
Cataract Surgery

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Rupert Menapace

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total-Prostaglandin and PGE2 level in aqueous humor	pg/mL	5 minutes after laser procedure (LCS)
Secondary	Change in Pupilsize	in mm	baseline, immediately after laser, 5 min after laser