Glaucoma
Conditions
Keywords
patient with refractory glaucoma
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.
Interventions
DEVICEArtificial drainage implant
Artificial drainage implant is used for intra ocular pressure reduction in patient with refractory glaucoma
Sponsors
Aurolab
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intra Ocular Pressure (IOP) | One year | Mean Intraocular pressure (IOP) reduction from pre operative IOP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success rate | 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) |
| Number of patients with adverse events as a measure of safety | one year | to assess the incidence of post operative adverse events |
Countries
India
Contacts
Primary ContactDr. Prashanth Ranganath, MBBS., MS.,
Backup ContactMr.S.Karthi Kumar, M.Pahrmacy
Outcome results
None listed