An Early Feasibility, Prospective, Single-Arm Study of the Polaris System

NCT06990074 | Recruiting FDA Device

• 1 other identifier: HS-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A multicenter, single-arm, prospective, non-randomized, non-masked study.

Conditions

Cataract, Age-Related

Outcome Measures

Primary Outcomes (1)

• Rate of safety events

  Rate of ocular adverse events in the study eye

  12 weeks

Study Arms (1)

Participants with age-related uncomplicated cataract

EXPERIMENTAL

Single eye cataract robot-assisted cataract surgery. Participants will receive intraoperative eye preparation according to the standard of care for cataract surgery. Under general anesthesia, a docking procedure between the study eye and the medical device will be completed. The surgeon will use the Polaris System to perform initial surgical tasks and perform the initial portion of the affected lens extraction. Finally, the surgeon will use the Polaris System to complete the lens extraction and perform the final surgical tasks, including the intraocular lens implantation.

Device: cataract surgery

Interventions

cataract surgery DEVICE

Robot-assisted cataract surgery

Participants with age-related uncomplicated cataract

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Horizon Surgical Systems Inc.: lead

Study Sites (1)

Clinica Quesada SA de CV

San Salvador, San Salvador Department, El Salvador

RECRUITING

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Pooria Kashani Vice-president of Product

CONTACT

908-477-8382; pkashani@horizonsurgicalsystems.com

Jean-Pierre Hubschman, Chief Executive Officer

CONTACT

310-691-9061; jphubschman@horizonsurgicalsystems.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 25, 2025
• Study Start: September 23, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EL (1)