An Early Feasibility, Prospective, Single-Arm Study of the Polaris System
ConditionCataract, Age-Related
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorHorizon Surgical Systems Inc.
About this trial
A multicenter, single-arm, prospective, non-randomized, non-masked study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female, between 40 and 75 (inclusive) years of age (measured at baseline)
A slit-lamp diagnosis of uncomplicated, age-related visually significant cataract that is not posterior polar or congenital
Eligible to undergo cataract extraction by phacoemulsification with intraocular lens (IOL) implantation
Able and willing to comply with all study procedures
Disqualifiers
Contraindication to general anesthesia
Posterior polar or congenital cataract
Previous history of vitrectomy, corneal, refractive, or cataract surgery
Concurrent participation in another ophthalmological clinical study
Trial design
Design model
Single group
Treatments tested in this trial
cataract surgery
DeviceRobot-assisted cataract surgery
cataract surgery
DeviceRobot-assisted cataract surgery, designed to provide superior precision and increase the safety profile of the current standard of care.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Participants with age-related uncomplicated cataractExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of safety events
Rate of ocular adverse events in the study eye
Time frame
12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov