Status:
RECRUITING
An Early Feasibility, Prospective, Single-Arm Study of the Polaris System
Lead Sponsor:
Horizon Surgical Systems Inc.
Conditions:
Cataract, Age-Related
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
A multicenter, single-arm, prospective, non-randomized, non-masked study.
Detailed Description
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 o...
Eligibility Criteria
Inclusion
- 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
- Able to return for scheduled follow-up examinations
- Willing to adhere to the prescribed medication regimen (to prevent inflammation and infection)
- Provision of signed and dated informed consent form
Exclusion
- 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
- Allergies to any medications required in surgery, pre- and post-operative treatment
- Diagnosis of corneal disease or pathology that precludestransmission of optical coherence tomography (OCT) laser wavelength (e.g., corneal opacity), distorts OCT laser light (e.g., corneal scarring or history of radial keratotomy), or compromises engagement of the patient interface (e.g., megalocornea or pterygium), in the opinion of the Investigator
- History of poor pupil dilation, demonstration of poor reaction to pupil-dilation drugs (minimum 7 mm dilation should be targeted for study), diagnosis of a pupillary defect that precludes the iris from adequate peripheral retraction, and/or diagnosis of floppy iris syndrome or iris dyscoria
- Current or prior use of concomitant medications known to cause floppy iris syndrome (e.g., alpha-blockers, such as Flomax)
- Compromised cornea (e.g., Fuchs endothelial dystrophy)
- History of lens or zonular instability
- Immunocompromised or diagnosis of ophthalmic disease: ocular herpes zoster or simplex, lupus, collagenosis or other acute or chronic illnesses that increase the risk to the subject or confounds the outcomes of this study, in the opinion of the Investigator
- Developmental disability or cognitive impairment that would make informed consent and the assessment of visual acuity impossible, in the opinion of the Investigator
- History of significant ocular trauma
- History of iritis or uveitis
- Pregnant women, as confirmed via urine pregnancy test for women of child-bearing age at screening
Key Trial Info
Start Date :
September 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06990074
Start Date
September 23 2025
End Date
October 1 2026
Last Update
January 5 2026
Active Locations (1)
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1
Clinica Quesada SA de CV
San Salvador, San Salvador Department, El Salvador