MINIject (MINI SO627) in Patients With Open Angle Glaucoma Using Single Operator Delivery Tool
NCT ID: NCT04517786
Last Updated: 2023-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
21 participants
INTERVENTIONAL
2021-01-15
2023-12-31
Brief Summary
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Detailed Description
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The primary endpoint is the reduction in medicated mean diurnal IOP at 6 months follow up compared to medicated diurnal IOP at baseline visit.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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MINIject CS627 implant
MINIject 627 implant is used to reduce intra-ocular pressure in the eye. It is implanted through a minimally-invasive glaucoma surgical intervention in a stand alone procedure.
MINIject CS627 implant
MINI SO627 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant (CS627) and a single operator delivery tool.
The delivery tool is a single-use tool, designed for inserting the CS627 implant into the suprachoroidal space in the eye.
Interventions
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MINIject CS627 implant
MINI SO627 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant (CS627) and a single operator delivery tool.
The delivery tool is a single-use tool, designed for inserting the CS627 implant into the suprachoroidal space in the eye.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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International Drug Development Institute
OTHER
iSTAR Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Zubair Hussain, PhD
Role: STUDY_DIRECTOR
iSTAR
Locations
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Maxivision Super Speciality Eye Hospital
Hyderabad, , India
Panama Eye Center
Panama City, , Panama
Countries
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Other Identifiers
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ISM10
Identifier Type: -
Identifier Source: org_study_id
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