NCT04321226

Femtosecond Laser-assisted Astigmatism Treatment

Femtosecond Laser-assisted Astigmatism Treatment (FLAAT)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 40 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 including arcuate incisions (AI) correcting astigmatism, also referred to as arcuate keratotomy (AK). The FSL will perform anterior capsulotomy and lens fragmentation in individuals suffering from age-related cataract with need of cataract surgery and additionally perform arcuate keratotomy in individuals with more than 1.0 Diopter (dpt) of astigmatism. Cataract surgery will be performed in subjects who have signed an informed consent form. Postoperative examinations will be implemented in accordance with the approved Investigational Plan on subjects and includes: postoperative refraction, visual acuity, slitlamp examination, and corneal topography

Conditions

• Age Related Cataracts
• Astigmatism

Interventions

Type	Name	Description
DEVICE	Femtosecond Laser guided Arcuate Keratotomy	Astigmatism will be reduced in cataract surgery using a low energy Femtosecond Laser device

Timeline

• Start date: 2017-07-10
• Primary completion: 2022-03-05
• Completion: 2022-04-01
• First posted: 2020-03-25
• Last updated: 2021-02-24

Locations

1 site across 1 country: Austria