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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 April 2022 |
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Main ID: |
NCT03374553 |
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Date of registration:
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12/12/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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MINIject 636 in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
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Scientific title:
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A Prospective, Open, Multicentre Clinical Trial Analysing the Effectiveness and Safety of MINIject 636 in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications |
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Date of first enrolment:
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November 25, 2017 |
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Target sample size:
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52 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03374553 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Colombia
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India
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Panama
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Contacts
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Name:
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Zubair Hussain, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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iSTAR Medical |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit
or earlier.
- Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to
Shaffer Angle Grading System.
- Glaucoma not adequately controlled
Exclusion Criteria:
- Diagnosis of glaucoma other than open angle glaucoma
- Grade 2, grade 1 and grade 0 according to Shaffer Angle Grading System.
- Neovascular glaucoma in the study eye
- Prior glaucoma surgery in the study eye
- Clinically significant corneal disease
- Patients with poor vision
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Open Angle Glaucoma
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Intervention(s)
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Device: MINI DO636
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Device: MINI SO636
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Primary Outcome(s)
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Reduction in medicated diurnal IOP
[Time Frame: 6 months after surgery]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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