Evaluate the Safety and Effectiveness of iSTAR Medical's MINIject Implant for Lowering Intraocular Pressure (IOP) in Subjects With Primary Open-angle Glaucoma.

  • STATUS
    Recruiting
  • End date
    Mar 4, 2027
  • participants needed
    975
  • sponsor
    iSTAR Medical
Updated on 4 September 2021
drainage
medical therapy
cataract
glaucoma
brimonidine tartrate ophthalmic solution
intraocular pressure
glaucoma surgery
filtration surgery

Summary

Evaluate the safety and effectiveness of iSTAR Medical's MINIject implant for lowering intraocular pressure (IOP) in subjects with primary open-angle glaucoma.

Description

This is a prospective, multicenter, masked clinical trial to evaluate the safety and effectiveness of iSTAR Medical's MINIject implant for lowering intraocular pressure (IOP) in subjects with primary open-angle glaucoma.

Details
Condition Glaucoma, Ocular Hypertension
Treatment MINIject™ Implant
Clinical Study IdentifierNCT05024695
SponsoriSTAR Medical
Last Modified on4 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Males and females, 46 years of age or older
A diagnosis of primary open-angle glaucoma, who are candidates for medical therapy, laser treatment, or glaucoma-filtering surgery
Pseudophakic with prior uncomplicated cataract surgery

Exclusion Criteria

Angle closure, congenital, or secondary glaucoma
Diagnosed degenerative visual disorders
Clinically significant intraocular inflammation or infection
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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