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

Phase 4

• Conditions: Glaucoma
• Interventions: Device: Artificial drainage implant

• Registration Number: NCT01401088
• Lead Sponsor: Aurolab

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-20
• Study First Submitted QC: 2011-07-22
• Study First Posted: 2011-07-25
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-02
• Last Update Posted: 2013-01-03
• Primary Completion: 2013-11
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Artificial drainage implant	Artificial drainage implant	Aurolab Artificial Drainage Implant (AADI) on intraocular pressure reduction will be implanted in patients with refractory glaucoma.

Primary Outcome Measures

Name	Time	Method
Intra Ocular Pressure (IOP)	One year	Mean Intraocular pressure (IOP) reduction from pre operative IOP

Secondary Outcome Measures

Name	Time	Method
Success rate	one year	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	one year	to assess the incidence of post operative adverse events

Trial Locations

Locations (1)

Aravind Eye Hospital; 🇮🇳 Madurai, Tamilnadu, India