Early feasibility test of the Polaris robotic system for cataract surgery
Official title: An Early Feasibility, Prospective, Single-Arm Study of the Polaris System
Run by Horizon Surgical Systems Inc. · NCT06990074 · Data updated 2026-11-12
This trial will try the Polaris robotic system to see if it can safely help surgeons perform cataract surgery in adults with age-related cataracts.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 75 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Horizon Surgical Systems Inc. Industry-sponsored |
| Locations | 1 site (San Salvador, San Salvador Department) |
| Status | Recruiting |
| Started | September 23, 2025 |
| Main results expected | August 2026 |
| Study ends | October 2026 |
| Registry record updated | January 5, 2026 |
| Trial ID | NCT06990074 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 40 to 75 with uncomplicated, visually significant age-related cataracts who are eligible for phacoemulsification with intraocular lens implantation and can comply with follow-up are ideal candidates.
✕Probably not a fit
Patients with posterior polar or congenital cataracts, prior vitrectomy or corneal/refractive/cataract surgery, corneal disease that limits visualization, allergies to required medications, or contraindications to anesthesia may not benefit from this device.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, prospective, single-arm feasibility study that enrolls adults with uncomplicated age-related cataracts to undergo robot-assisted phacoemulsification with intraocular lens implantation using the Polaris System. Participants are screened, provide informed consent, and after confirming eligibility are sequentially assigned to receive the intervention. Each participant will have the procedure and four scheduled follow-up visits over 90 days to monitor safety and device performance. Up to three research sites will participate, with standard perioperative medications and follow-up assessments recorded.
Why it matters
Potential benefit: If successful, the Polaris System could improve surgical precision and reduce intraoperative complications during cataract surgery.
How similar studies have gone: Robotic assistance for intraocular procedures is relatively novel and there are few prior clinical reports for robot-assisted cataract systems, so this early feasibility work is largely exploratory.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Clinica Quesada SA de CV
San Salvador, San Salvador Department, El Salvador Recruiting
Study contacts
- Study coordinator: Pooria Kashani Vice-president of Product
- Email: pkashani@horizonsurgicalsystems.com
- Phone: 908-477-8382
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Impact of Phaco Tip Location on Early Postoperative Outcomes in Cataract Surgery
This observational study tests whether the position of the phacoemulsification tip during cataract surgery affects early changes in the cornea and vision in people with age-related cataracts.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.