This is a prospective, open-label clinical study designed to evaluate the performance and safety of the JASPER™ Robotic Surgical System during cataract surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
The JASPER™ Robotic Surgical System is a robotically assisted surgical system intended to assist ophthalmic surgeons in performing cataract surgery.
Asian Eye Instiitute
Makati City, National Capital Region, Philippines
RECRUITINGSuccessful completion of planned Robotic-Assisted cataract surgery
Proportion of study eyes in which the planned robotic cataract surgery is completed using the JASPER™ Robotic Surgical System without conversion to manual technique.
Time frame: Intra-operative
Incidence and Type of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Incidence and type of all AEs and SAEs occurring intraoperatively and during the postoperative follow-up period.
Time frame: From surgery through 30 days post-procedure
Distribution of pre and postoperative Best Corrected Visual acuity
Distribution of preoperative and postoperative BCVA
Time frame: Baseline and up to 30 days post-procedure
Postoperative Ophthalmic examination findings
Postoperative slit lamp and dilated fundus examinations findings
Time frame: Up to 30 days post-procedure
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