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. The laser will be reduced to image the Berger space. If not visible, the space will be enhanced with BSS and Volon A to visualize the BS. Cataract surgery will be performed in subjects who have signed an informed consent form. Macula thickness will be measured with Spectralis OCT on screening date. Postoperative examinations will be implemented in accordance with the approved investigational plan on subjects and includes: visual acuity, slitlamp examination and retinal oct imaging.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
80
Femtosecond Laser assisted Cataract Surgery will be performed uni- or bilateral
Medical University of Vienna
Vienna, Austria
RECRUITINGThe primary objective is a Berger Space larger than 400μm
The number of patients with visible Berger space and the capacity (volume) of the visible Berger Space will be determined by using the intraoperative OCT recording
Time frame: intraoperative
Difference of central macular thickness between time points
Difference in Central Macular Thickness (CMT) with time.
Time frame: Baseline to 1day, 1 week, 3 weeks
Intraocular pressure in different timepoints
Intraocular pressure changes with time.
Time frame: Baseline to 1day, 1 week, 3 weeks
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