Evaluation of Safety and Efficacy of Glaucoma Shunt (Aurolab Artificial Drainage Implant) in Refractory Glaucoma

Study Overview
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Brief Summary
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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.

Detailed Description
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Aurolab Artificial Drainage Implant is a non resistant tube device based on Baerveldt implant. It reduces intra ocular pressure by draining aqueous from anterior chamber into sub-conjunctival space formed around base of the implant. Reduction of intraocular pressure prevents further damage to optic nerve and functional visual field loss in advanced refractory glaucoma.

Official Title
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Evaluation of Safety and Efficacy of Glaucoma Shunt (Aurolab Artificial Drainage Implant) in Refractory Glaucoma

Conditions
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Glaucoma

Intervention / Treatment
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* Device: Artificial drainage implant


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artificial drainage implant<br>Aurolab Artificial Drainage Implant (AADI) on intraocular pressure reduction will be implanted in patients with refractory glaucoma. | Device: Artificial drainage implant<br>* Artificial drainage implant is used for intra ocular pressure reduction in patient with refractory glaucoma<br>* Other names: AADI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra Ocular Pressure (IOP) | Mean Intraocular pressure (IOP) reduction from pre operative IOP | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate | Success rate (defined as Inraocular pressure (IOP) of 5mmHg to 20 mmHg and at least a 20% reduction in IOP without visually devastating complications or additional glaucoma surgery) | one year | 
| Number of patients with adverse events as a measure of safety | to assess the incidence of post operative adverse events | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient with refractory glaucoma