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

Primary Purpose

Glaucoma

Status
Unknown status
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Artificial drainage implant
Sponsored by
Aurolab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring patient with refractory glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Aravind Eye HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Artificial drainage implant

Arm Description

Aurolab Artificial Drainage Implant (AADI) on intraocular pressure reduction will be implanted in patients with refractory glaucoma.

Outcomes

Primary Outcome Measures

Intra Ocular Pressure (IOP)
Mean Intraocular pressure (IOP) reduction from pre operative IOP

Secondary Outcome Measures

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)
Number of patients with adverse events as a measure of safety
to assess the incidence of post operative adverse events

Full Information

First Posted
July 20, 2011
Last Updated
January 2, 2013
Sponsor
Aurolab
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1. Study Identification

Unique Protocol Identification Number
NCT01401088
Brief Title
Evaluation of Safety and Efficacy of Glaucoma Shunt (Aurolab Artificial Drainage Implant) in Refractory Glaucoma
Acronym
AADI
Official Title
Evaluation of Safety and Efficacy of Glaucoma Shunt (Aurolab Artificial Drainage Implant) in Refractory Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
November 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aurolab

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
patient with refractory glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Artificial drainage implant
Arm Type
Experimental
Arm Description
Aurolab Artificial Drainage Implant (AADI) on intraocular pressure reduction will be implanted in patients with refractory glaucoma.
Intervention Type
Device
Intervention Name(s)
Artificial drainage implant
Other Intervention Name(s)
AADI
Intervention Description
Artificial drainage implant is used for intra ocular pressure reduction in patient with refractory glaucoma
Primary Outcome Measure Information:
Title
Intra Ocular Pressure (IOP)
Description
Mean Intraocular pressure (IOP) reduction from pre operative IOP
Time Frame
One year
Secondary Outcome Measure Information:
Title
Success rate
Description
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)
Time Frame
one year
Title
Number of patients with adverse events as a measure of safety
Description
to assess the incidence of post operative adverse events
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Prashanth Ranganath, MBBS., MS.,
Phone
+91 452 4356100
Ext
118
Email
loweriop@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mr.S.Karthi Kumar, M.Pahrmacy
Phone
+91 452 4356100
Ext
229
Email
crd@aurolab.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Prashanth Ranganath, MBBS., MS.,
Organizational Affiliation
Aravind Eye Hospital, Madurai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aravind Eye Hospital
City
Madurai
State/Province
Tamilnadu
ZIP/Postal Code
625020
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mr. S.Karthi Kumar, M. Pharmacy
Phone
+91 452 3096100
Ext
229
Email
crd@aurolab.com
First Name & Middle Initial & Last Name & Degree
Ms. Sophia, M.Sc
Phone
+91 452 4356100
Ext
364
Email
clinicaltrials@aravind.org
First Name & Middle Initial & Last Name & Degree
Dr. Prashanth Ranganath, MBBS., MS.,

12. IPD Sharing Statement

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

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