A multicenter, single-arm, prospective, non-randomized, non-masked study.
The study aims to assess the safety of the Polaris System in assisting surgeons to perform cataract surgery. The Polaris System is intended to enhance precision and safety over the current standard of care by employing improved stability controls and augmented visualization properties, enabling safer surgical decisions and finer control of surgical instruments. This study will be conducted at up to 3 research sites. After the informed consent process, potential participants will be considered enrolled in the study and undergo the screening evaluation. Following confirmation of eligibility, selected participants will be sequentially assigned to undergo robot-assisted cataract surgery and receive four scheduled follow-ups over 90 days, post-intervention.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Robot-assisted cataract surgery
Robot-assisted cataract surgery, designed to provide superior precision and increase the safety profile of the current standard of care.
Clinica Quesada SA de CV
San Salvador, San Salvador Department, El Salvador
RECRUITINGRate of safety events
Rate of ocular adverse events in the study eye
Time frame: 12 weeks
Jean-Pierre Hubschman, Chief Executive Officer
CONTACT
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