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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2013

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Artificial drainage implant
    • Aurolab Artificial Drainage Implant (AADI) on intraocular pressure reduction will be implanted in patients with refractory glaucoma.

Clinical Trial Outcome Measures

Primary Measures

  • Intra Ocular Pressure (IOP)
    • Time Frame: One year
    • Mean Intraocular pressure (IOP) reduction from pre operative IOP

Secondary Measures

  • Success rate
    • Time Frame: 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
    • Time Frame: one year
    • to assess the incidence of post operative adverse events

Participating in This Clinical Trial

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 – IOPā‰„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)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Aurolab
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Dr. Prashanth Ranganath, MBBS., MS.,, Principal Investigator, Aravind Eye Hospital, Madurai
  • Overall Contact(s)
    • Dr. Prashanth Ranganath, MBBS., MS.,, +91 452 4356100, loweriop@gmail.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.