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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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12 December 2020 |
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Main ID: |
NCT00326066 |
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Date of registration:
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12/05/2006 |
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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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A Study of the iStent in Combo With Cataract Surgery in Newly Diagnosed Open Angle Glaucoma or OH Patients.
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Scientific title:
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A Study of the Trabecular Micro-bypass Stent in Combination With Cataract Surgery in Subjects With Newly Diagnosed Open Angle Glaucoma and Subjects Diagnosed With Ocular Hypertension |
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Date of first enrolment:
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February 2005 |
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Target sample size:
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47 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00326066 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel 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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Austria
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Germany
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Netherlands
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Spain
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Turkey
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Contacts
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Name:
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Head of Clinical Affairs |
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Address:
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Telephone:
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Email:
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Affiliation:
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Glaukos Corporation |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Newly diagnosed with open-angle glaucoma (OAG) or Ocular Hypertension with subjects
not yet taking any glaucoma medications or recently diagnosed with mild open-angle
glaucoma and are currently being treated with up to 2 glaucoma medications.
- All subjects must need cataract surgery.
Exclusion Criteria:
- Angle closure glaucoma
- Secondary glaucomas except pseudoexfoliative and pigmentary; no neovascular, uveitic
or angle recession glaucoma
- Prior glaucoma procedures (eg trabeculectomy, viscocanalostomy, ALT, SLT, shunt
implant, collagen implant, cyclo destructive procedures etc)
- Fellow eye already enrolled
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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Procedure: cataract surgery only
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Device: Glaucoma Surgery
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Primary Outcome(s)
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Efficacy
[Time Frame: 24 months]
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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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