Status:
UNKNOWN
Evaluation of Safety and Efficacy of Glaucoma Shunt (Aurolab Artificial Drainage Implant) in Refractory Glaucoma
Lead Sponsor:
Aurolab
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 fo...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01401088
Start Date
July 1 2011
End Date
December 1 2013
Last Update
January 3 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Aravind Eye Hospital
Madurai, Tamil Nadu, India, 625020