Augenklinik ORASIS AG
Reinach, Canton of Aargau, 5734, Switzerland
NCT Number: NCT04082273
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
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Notify Me40 year and older
All sexes
Interventional
Not applicable
Reinach, Canton of Aargau, 5734, Switzerland
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Baseline = Pre-operative, Follow-up = 12 days, 4 weeks and 6 weeks after surgery
Time frame: Baseline = Pre-operative, Follow-up = 12 days, 4 weeks and 6 weeks after surgery
Time frame: Baseline = Pre-operative, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery
Time frame: Baseline = Pre-operative, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery
Time frame: Baseline = Treatment day
Time frame: Baseline = Treatment day
Time frame: 1 day postoperative and 12 days postoperative
Presence of Descemet membrane detachment, posterior and anterior wound gape, if present size) will be analyzed on OCT images
Time frame: Baseline = Treatment day, Follow-up = 1 day, 12 days, 4 weeks and 6 weeks after surgery
Time frame: Baseline = Treatment day
Analyzed on intra-operative Z8 OCT images
Ziemer Ophthalmic Systems AG
Industry
A Single Center, Randomized Control Study to Compare Efficacy and Safety of Femto-laser Created Clear Corneal Incisions with Manually Created Clear Corneal Incisions During Cataract Surgery
Acronym: Z8_CCI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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