The aim of this study is to test the hypothesis, that in terms of Surgically Induced corneal Astigmatism (SIA), Higher-order Aberrations (HOA), and wound geometry the femtosecond clear corneal incisions (CCIs) created during cataract surgery are not inferior when compared to manual CCIs. The potential risks associated with application of the femtosecond laser in this study are no greater or in most cases less than those associated with the standard manual cataract surgical procedure, and the potential benefits (such as precision and reproducibility) are greater than with the standard manual cataract surgery. Therefore, the risk-to-benefit ratio is very low, such that the potential benefits for a subject participating in this study exceed the potential risks
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Cataract Surgery on study eye according to conventional procedure, with the exception of three steps (Capsulotomy, Lens Fragmentation and Clear Corneal Incisions) which are performed with a Femtosecond Laser in the laser treatment group. Equipment uesd for measurements is the same for both groups and in line with the normal equipment used for the conventional cataract treatment
Cataract surgery will be performed conventionally, this means the clear corneal incisions will be performed manually by a blade, the capsulorhexis will be performed manually by a hook, and the lens extraction will be done by phacoemulsification
Augenklinik ORASIS AG
Reinach, Canton of Aargau, Switzerland
Change from baseline (pre-operative) Surgically Induced corneal Astigmatism (SIA) measured by means of corneal topography Galilei G2
Time frame: Baseline = Pre-operative, Follow-up = 12 days, 4 weeks and 6 weeks after surgery
Change from baseline (pre-operative) Higher-order aberrations (HOAs) by means of aberrometry using Galilei G2
Time frame: Baseline = Pre-operative, Follow-up = 12 days, 4 weeks and 6 weeks after surgery
Central corneal thickness (CCT)
Time frame: Baseline = Pre-operative, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery
Endothelial cell density (ECD)
Time frame: Baseline = Pre-operative, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery
Effective Phacoemulsification Time (EPT)
Time frame: Baseline = Treatment day
Ultrasound total time (US)
Time frame: Baseline = Treatment day
Achieved CCI architecture
Presence of Descemet membrane detachment, posterior and anterior wound gape, if present size) will be analyzed on OCT images
Time frame: 1 day postoperative and 12 days postoperative
Intra- and post-operative CCI related complications rate
Time frame: Baseline = Treatment day, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery
FEMTO LDV Z8 OCT auto - detection accuracy
Analyzed on intra-operative Z8 OCT images
Time frame: Baseline = Treatment day
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