Femtosecond Laser-assisted Astigmatism Treatment (FLAAT)
Status and phase
Conditions
Treatments
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 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
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Age-related cataract necessitating lens extraction and posterior IOL implantation
- Regular corneal astigmatism between 1.0 and 2.5 DPT
- Age 40 and older (females of childbearing age will be interviewed if pregnancy is possible)
Exclusion criteria
- Corneal abnormality
- Preceding ocular surgery or trauma
- Uncontrolled glaucoma
- Proliferative diabetic retinopathy
- Iris neovascularization
- History of uveitis/iritis
- Microphthalmus
- Recurrent intraocular inflammation of unknown etiology
- Blind fellow eye
- Uncontrolled systemic or ocular disease
Trial design
Primary purpose
Allocation
Interventional model
Masking
130 participants in 1 patient group
Trial contacts and locations
Loading...
Central trial contact
Luca Schwarzenbacher, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal