An Early Feasibility, Prospective, Single-Arm Study of the Polaris System (NCT06990074) | Clinical Trial Compass
RecruitingNot Applicable
An Early Feasibility, Prospective, Single-Arm Study of the Polaris System
El Salvador30 participantsStarted 2025-09-23
Plain-language summary
A multicenter, single-arm, prospective, non-randomized, non-masked study.
Who can participate
Age range40 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …