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

• Success rate [ Time Frame: one year ] [ Designated as safety issue: No ]
  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)
• Number of patients with adverse events as a measure of safety [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  to assess the incidence of post operative adverse events

• Success rate [ Time Frame: one year ] [ Designated as safety issue: No ]
  Success rate (defined as IOP of 5mmHg to 20 mmHg and at least a 20% reduction in IOP without visually devastating complications or additional glaucoma surgery)
• Number of patients with post operative complications [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  to assess the incidence of post operative complications

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.

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.

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)