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
  Purpose

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.


Condition Intervention Phase
Glaucoma
Device: Artificial drainage implant
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Efficacy of Glaucoma Shunt (Aurolab Artificial Drainage Implant) in Refractory Glaucoma

Resource links provided by NLM:


Further study details as provided by Aurolab:

Primary Outcome Measures:
  • Intra Ocular Pressure (IOP) [ Time Frame: One year ] [ Designated as safety issue: No ]
    Mean Intraocular pressure (IOP) reduction from pre operative IOP


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 30
Study Start Date: July 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Artificial drainage implant
Aurolab Artificial Drainage Implant (AADI) on intraocular pressure reduction will be implanted in patients with refractory glaucoma.
Device: Artificial drainage implant
Artificial drainage implant is used for intra ocular pressure reduction in patient with refractory glaucoma
Other Name: AADI

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01401088

Contacts
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

Locations
India
Aravind Eye Hospital Recruiting
Madurai, Tamilnadu, India, 625020
Contact: Mr. S.Karthi Kumar, M. Pharmacy    +91 452 3096100 ext 229    crd@aurolab.com   
Contact: Ms. Sophia , M.Sc    +91 452 4356100 ext 364    clinicaltrials@aravind.org   
Principal Investigator: Dr. Prashanth Ranganath, MBBS., MS.,         
Sponsors and Collaborators
Aurolab
Investigators
Principal Investigator: Dr. Prashanth Ranganath, MBBS., MS., Aravind Eye Hospital, Madurai
  More Information

No publications provided

Responsible Party: Aurolab
ClinicalTrials.gov Identifier: NCT01401088     History of Changes
Other Study ID Numbers: 1PN1011049
Study First Received: July 20, 2011
Last Updated: January 2, 2013
Health Authority: India: Ministry of Health

Keywords provided by Aurolab:
patient with refractory glaucoma

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on October 19, 2014