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

Glaucoma Clinical Trial

— AADI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01401088
• Other study ID #: 1PN1011049
• Status: Recruiting
• Phase: Phase 4
• First received: July 20, 2011
• Last updated: January 2, 2013
• Start date: July 2011
• Est. completion date: December 2013

Study information

• Verified date: January 2013
• Source: Aurolab
• Contact: Dr. Prashanth Ranganath, MBBS., MS.,
• Phone: +91 452 4356100
• Email: loweriop[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

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

Locations

Country	Name	City	State
India	Aravind Eye Hospital	Madurai	Tamilnadu

Sponsors (1)

Lead Sponsor	Collaborator
Aurolab

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra Ocular Pressure (IOP)	Mean Intraocular pressure (IOP) reduction from pre operative IOP	One year	No
Secondary	Success rate	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)	one year	No
Secondary	Number of patients with adverse events as a measure of safety	to assess the incidence of post operative adverse events	one year	Yes