An Early Feasibility, Prospective, Single-Arm Study of the Polaris System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: cataract surgery, cataract surgery.
- Who it may be relevant to
- Registry conditions: Cataract, Age-Related. Basic parameters: 40 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- El Salvador
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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.
Primary outcome measures
- Rate of safety events [Time frame: 12 weeks]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
El Salvador · 1 center
- Clinica Quesada SA de CV — San Salvador
Identifiers
NCT: NCT06990074 · HS-001