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What is the primary objective of this study?

The purpose of this study is to evaluate the efficacy and safety of Aurolab Artificial Drainage Implant (AADI) on intraocular pressure reduction in patients with refractory glaucoma.

Who is eligible to participate?

Inclusion Criteria: - 18 years of age or older - 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: - Age<18 years - 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)

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Glaucoma

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:Artificial drainage implantArtificial drainage implant is used for intra ocular pressure reduction in patient with refractory glaucoma

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Artificial drainage implantAurolab Artificial Drainage Implant (AADI) on intraocular pressure reduction will be implanted in patients with refractory glaucoma.

Study Status

Unknown status

Start Date: July 2011

Completed Date: December 2013

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Intra Ocular Pressure (IOP)

Secondary Outcome: Success rate

Study sponsors, principal investigator, and references

Principal Investigator: Dr. Prashanth Ranganath, MBBS., MS.,

Lead Sponsor: Aurolab

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01401088