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

December 31, 2025 updated by: Horizon Surgical Systems Inc.
A multicenter, single-arm, prospective, non-randomized, non-masked study.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 of care by employing improved stability controls and augmented visualization properties, enabling safer surgical decisions and finer control of surgical instruments.

This study will be conducted at up to 3 research sites. After the informed consent process, potential participants will be considered enrolled in the study and undergo the screening evaluation. Following confirmation of eligibility, selected participants will be sequentially assigned to undergo robot-assisted cataract surgery and receive four scheduled follow-ups over 90 days, post-intervention.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • El Salvador
    • San Salvador Department
      • San Salvador, San Salvador Department, El Salvador

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants with age-related uncomplicated cataract

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
Robot-assisted cataract surgery
Device: cataract surgery
Robot-assisted cataract surgery, designed to provide superior precision and increase the safety profile of the current standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of safety events
Time Frame: 12 weeks
Rate of ocular adverse events in the study eye
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Horizon Surgical Systems Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

May 6, 2025

First Submitted That Met QC Criteria

May 19, 2025

First Posted (Actual)

May 25, 2025

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

December 31, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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