Actively Recruiting

Phase Not Applicable
Age: 40Years - 75Years
All Genders
NCT06990074

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

Led by Horizon Surgical Systems Inc. · Updated on 2026-01-05

30

Participants Needed

1

Research Sites

53 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 40Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, between 40 and 75 (inclusive) years of age
  • Diagnosed with uncomplicated, age-related visually significant cataract (not posterior polar or congenital)
  • Eligible for cataract extraction by phacoemulsification with intraocular lens 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
  • Signed and dated informed consent form provided
Not Eligible

You will not qualify if you...

  • Contraindication to general anesthesia
  • Posterior polar or congenital cataract
  • Previous history of vitrectomy, corneal, refractive, or cataract surgery
  • Participation in another ophthalmological clinical study
  • Allergies to any required medications for surgery or treatment
  • Corneal disease or pathology affecting optical coherence tomography laser transmission or engagement
  • History of poor pupil dilation or pupillary defects precluding adequate iris retraction
  • Diagnosis of floppy iris syndrome or iris dyscoria
  • Current or prior use of medications causing floppy iris syndrome (e.g., alpha-blockers like Flomax)
  • Compromised cornea (e.g., Fuchs endothelial dystrophy)
  • History of lens or zonular instability
  • Immunocompromised status or ophthalmic diseases increasing risk or confounding outcomes
  • Developmental disability or cognitive impairment preventing informed consent or visual acuity assessment
  • History of significant ocular trauma
  • History of iritis or uveitis
  • Pregnant women confirmed by urine pregnancy test at screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Clinica Quesada SA de CV

San Salvador, San Salvador Department, El Salvador

Actively Recruiting

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Research Team

P

Pooria Kashani Vice-president of Product

CONTACT

J

Jean-Pierre Hubschman, Chief Executive Officer

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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