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

January 2, 2013 updated by: Aurolab
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dr. Prashanth Ranganath, MBBS., MS.,
  • Phone Number: 118 +91 452 4356100
  • Email: loweriop@gmail.com

Study Contact Backup

  • Name: Mr.S.Karthi Kumar, M.Pahrmacy
  • Phone Number: 229 +91 452 4356100
  • Email: crd@aurolab.com

Study Locations

  • India
    • Tamilnadu
      • Madurai, Tamilnadu, India, 625020
        • Recruiting
        • Aravind Eye Hospital
        • Contact:
          • Mr. S.Karthi Kumar, M. Pharmacy
          • Phone Number: 229 +91 452 3096100
          • Email: crd@aurolab.com
        • Contact:
        • Principal Investigator:
          • Dr. Prashanth Ranganath, MBBS., MS.,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • AADI

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
one year
Number of patients with adverse events as a measure of safety
Time Frame: one year
to assess the incidence of post operative adverse events
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aurolab

Investigators

  • Principal Investigator: Dr. Prashanth Ranganath, MBBS., MS.,, Aravind Eye Hospital, Madurai

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Anticipated)

November 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

July 20, 2011

First Submitted That Met QC Criteria

July 22, 2011

First Posted (Estimate)

July 25, 2011

Study Record Updates

Last Update Posted (Estimate)

January 3, 2013

Last Update Submitted That Met QC Criteria

January 2, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1PN1011049

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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