Cataract, Age-RelatedNCT06990074
An Early Feasibility, Prospective, Single-Arm Study of the Polaris System
A study testing cataract surgery in people with Cataract, Age-Related, run by Horizon Surgical Systems Inc. at 1 site in El Salvador.
Trial summary
A multicenter, single-arm, prospective, non-randomized, non-masked study. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Cataract, Age-Related
- What is being tested?
- cataract surgery
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEl Salvador
- Study dates
- 23 Sep 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jean-Pierre Hubschman, Chief Executive Officer contact
El Salvador1 site, 1 recruiting
- Recruiting
Clinica Quesada SA de CV
San Salvador, San Salvador Department
Gabriel Quesada, +503-6184-6996, gabriel.quesadalarez@gmail.com
About this study
A multicenter, single-arm, prospective, non-randomized, non-masked study.
Read the 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.
- Conditions
- Cataract, Age-Related
- Being tested
- cataract surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cataract surgeryDevice
Robot-assisted cataract surgery
cataract surgeryDevice
Robot-assisted cataract surgery, designed to provide superior precision and increase the safety profile of the current standard of care.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of safety events
Rate of ocular adverse events in the study eye
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start23 Sep 2025
- Primary completionAug 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract, Age-RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Horizon Surgical Systems Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990074
- Sponsor's protocol ID
- HS-001
- Status last verified
- Dec 2025
- First submitted
- 6 May 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Feasibility, Prospective, Single-Arm Study of the Polaris System
- ClinicalTrials.gov ID
- NCT06990074
- Acronym / sponsor ID
- HS-001
- Conditions
- Cataract, Age-Related
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Horizon Surgical Systems Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, single-arm, prospective, non-randomized, non-masked study.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with age-related uncomplicated cataract | Experimental | Device: cataract surgerySingle 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cataract surgeryRobot-assisted cataract surgery | Device | Participants with age-related uncomplicated cataract |
| cataract surgeryRobot-assisted cataract surgery, designed to provide superior precision and increase the safety profile of the current standard of care. | Device | Participants with age-related uncomplicated cataract |
Primary outcome
Rate of safety events
Time frame: 12 weeks
Rate of ocular adverse events in the study eye
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean-Pierre Hubschman, Chief Executive Officer contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cataract surgery in people with Cataract, Age-Related, run by Horizon Surgical Systems Inc. at 1 site in El Salvador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in El Salvador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pooria Kashani Vice-president of Product (908-477-8382, pkashani@horizonsurgicalsystems.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of safety events (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.