About this trial
This is a prospective, open-label clinical study designed to evaluate the performance and safety of the JASPER™ Robotic Surgical System during cataract surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patient aged 55 to 80 years
Willing and able to sign an informed consent, attend the clinic and comply with all study procedures and the study protocol
Patients are scheduled to undergo cataract surgery
Clear intraocular media, other than cataract
Disqualifiers
Prior ocular surgery or trauma in the study eye
Polar cataract in the study eye
Zonular instability or significant anterior segment abnormalities
Active ocular infection or uveitis
Trial design
Single group
Treatments tested in this trial
JASPER™ Robotic Surgical System
DeviceThe JASPER™ Robotic Surgical System is a robotically assisted surgical system intended to assist ophthalmic surgeons in performing cataract surgery.
Treatment groups
Trial outcomes
Primary outcomes
Successful 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.
Secondary outcomes
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.
Distribution of pre and postoperative Best Corrected Visual acuity
Distribution of preoperative and postoperative BCVA
Postoperative Ophthalmic examination findings
Postoperative slit lamp and dilated fundus examinations findings
Sponsors and contacts
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