Evaluation of Safety and Efficacy of Glaucoma Shunt (Aurolab Artificial Drainage Implant) in Refractory Glaucoma
AADI
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jul 2011
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 20, 2011
CompletedFirst Posted
Study publicly available on registry
July 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJanuary 3, 2013
January 1, 2013
2.3 years
July 20, 2011
January 2, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intra Ocular Pressure (IOP)
Mean Intraocular pressure (IOP) reduction from pre operative IOP
One year
Secondary Outcomes (2)
Success rate
one year
Number of patients with adverse events as a measure of safety
one year
Study Arms (1)
Artificial drainage implant
EXPERIMENTALAurolab Artificial Drainage Implant (AADI) on intraocular pressure reduction will be implanted in patients with refractory glaucoma.
Interventions
Artificial drainage implant is used for intra ocular pressure reduction in patient with refractory glaucoma
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aurolablead
Study Sites (1)
Aravind Eye Hospital
Madurai, Tamil Nadu, 625020, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Prashanth Ranganath, MBBS., MS.,
Aravind Eye Hospital, Madurai
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2011
First Posted
July 25, 2011
Study Start
July 1, 2011
Primary Completion
November 1, 2013
Study Completion
December 1, 2013
Last Updated
January 3, 2013
Record last verified: 2013-01