Evaluation of Safety and Efficacy of Glaucoma Shunt (Aurolab Artificial Drainage Implant) in Refractory Glaucoma
NCT ID: NCT01401088
Last Updated: 2013-01-03
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
PHASE4
30 participants
INTERVENTIONAL
2011-07-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Artificial drainage implant
Aurolab Artificial Drainage Implant (AADI) on intraocular pressure reduction will be implanted in patients with refractory glaucoma.
Artificial drainage implant
Artificial drainage implant is used for intra ocular pressure reduction in patient with refractory glaucoma
Interventions
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Artificial drainage implant
Artificial drainage implant is used for intra ocular pressure reduction in patient with refractory glaucoma
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Significant optic nerve damage and visual field loss due to glaucoma in eligible eyes
* Eligible eyes is considered at high risk of failure/complication following conventional filtering surgery
* Eyes with uncontrolled glaucoma with prior history of Filtering surgery/Uveitic/ Neovascular/Developmental glaucomas
* IOP≥18 mm of Hg with or without anti glaucoma medications
* If taking glaucoma medications, stable dose for 6 weeks
Exclusion Criteria
* Eyes with uncontrolled glaucoma expected to have favorable post-operative outcome by conventional trabeculectomy
* Corneal abnormalities that would preclude accurate IOP readings
* Uncontrolled systemic diseases
* Endothelial cell count\<1800cells/mm
* Any other active ocular disease,(active uveitis, ocular infection)
18 Years
ALL
No
Sponsors
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Aurolab
OTHER
Responsible Party
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Principal Investigators
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Dr. Prashanth Ranganath, MBBS., MS.,
Role: PRINCIPAL_INVESTIGATOR
Aravind Eye Hospital, Madurai
Locations
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Aravind Eye Hospital
Madurai, Tamil Nadu, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1PN1011049
Identifier Type: -
Identifier Source: org_study_id
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