Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Clinica Quesada SA de CV
San Salvador, San Salvador Department, El Salvador
Actively Recruiting
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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