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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Aurolab
Sponsor:
Information provided by (Responsible Party):
Aurolab
ClinicalTrials.gov Identifier:
NCT01401088
First received: July 20, 2011
Last updated: January 2, 2013
Last verified: January 2013

July 20, 2011
January 2, 2013
July 2011
November 2013   (final data collection date for primary outcome measure)
Intra Ocular Pressure (IOP) [ Time Frame: One year ] [ Designated as safety issue: No ]
Mean Intraocular pressure (IOP) reduction from pre operative IOP
Intra Ocular Pressure [ Time Frame: One year ] [ Designated as safety issue: No ]
Mean IOP reduction from pre operative IOP
Complete list of historical versions of study NCT01401088 on ClinicalTrials.gov Archive Site
  • Success rate [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    to assess the incidence of post operative adverse events
  • Success rate [ Time Frame: one year ] [ Designated as safety issue: No ]
    Success rate (defined as 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 post operative complications [ Time Frame: one year ] [ Designated as safety issue: Yes ]
    to assess the incidence of post operative complications
Not Provided
Not Provided
 
Evaluation of Safety and Efficacy of Glaucoma Shunt (Aurolab Artificial Drainage Implant) in Refractory Glaucoma
Evaluation of Safety and Efficacy of Glaucoma Shunt (Aurolab Artificial Drainage Implant) in Refractory Glaucoma

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.

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.

Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Glaucoma
Device: Artificial drainage implant
Artificial drainage implant is used for intra ocular pressure reduction in patient with refractory glaucoma
Other Name: AADI
Experimental: Artificial drainage implant
Aurolab Artificial Drainage Implant (AADI) on intraocular pressure reduction will be implanted in patients with refractory glaucoma.
Intervention: Device: Artificial drainage implant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2013
November 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact: Dr. Prashanth Ranganath, MBBS., MS., +91 452 4356100 ext 118 loweriop@gmail.com
Contact: Mr.S.Karthi Kumar, M.Pahrmacy +91 452 4356100 ext 229 crd@aurolab.com
India
 
NCT01401088
1PN1011049
No
Aurolab
Aurolab
Not Provided
Principal Investigator: Dr. Prashanth Ranganath, MBBS., MS., Aravind Eye Hospital, Madurai
Aurolab
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP