BridgeMD
New treatment option for Cataract, Age-Related
Official title An Early Feasibility, Prospective, Single-Arm Study of the Polaris System
ClinicalTrials.gov ID: NCT06990074
What this study is testing
- What it's testing
- A multicenter, single-arm, prospective, non-randomized, non-masked study.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75
You may be able to join if
- 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
You likely can't join if
- 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)...
See the full eligibility 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
- 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- San Salvador, San Salvador Department, El Salvador
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Salvador, San Salvador Department, El Salvador. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.