MINIject (MINI SO627) in Patients With Open Angle Glaucoma Using Single Operator Delivery Tool

  • STATUS
    Recruiting
  • End date
    Sep 30, 2023
  • participants needed
    25
  • sponsor
    iSTAR Medical
Updated on 2 August 2021

Summary

The study will assess safety and performance in patients with open-angle glaucoma uncontrolled by topical hypotensive medications who had previously been implanted with a MINIject glaucoma implant.

Description

The study will evaluate the efficacy and safety of MINI SO627 and IOP (Intra- ocular pressure) lowering effects with or without the use of glaucoma medications. The procedure will be a stand alone surgery. Patient follow up with several examinations up to 24 months after surgery.

The primary endpoint is the reduction in medicated mean diurnal IOP at 6 months follow up compared to medicated diurnal IOP at baseline visit.

Details
Condition Glaucoma, Open-Angle Glaucoma Eye, Glaucoma, Open-Angle Glaucoma Eye, Glaucoma, Open-Angle Glaucoma Eye, Glaucoma, Open-Angle Glaucoma Eye, Glaucoma, Open-Angle Glaucoma Eye
Treatment MINIject CS627 implant
Clinical Study IdentifierNCT04517786
SponsoriSTAR Medical
Last Modified on2 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier
Grade 3 or grade 4 according to Shaffer Angle Grading System
Glaucoma not adequately controlled by one to four different topical hypotensive medication(s), given each for at least one month, as confirmed by 21mmHg < IOP < 35 mmHg in the study eye at baseline visit

Exclusion Criteria

Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to Shaffer Angle Grading System in the study eye
Neovascular glaucoma in the study eye
Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant in the stud eye
Prior glaucoma surgery in the study eye
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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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