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

Aurolab

Status and phase

Unknown

Phase 4

Conditions

Glaucoma

Treatments

Device: Artificial drainage implant

Study type

Interventional

Funder types

Other

Identifiers

NCT01401088

1PN1011049

Details and patient eligibility

About

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.

Full description

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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)