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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artificial drainage implant | Experimental | Aurolab Artificial Drainage Implant (AADI) on intraocular pressure reduction will be implanted in patients with refractory glaucoma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial drainage implant | Device | Artificial drainage implant is used for intra ocular pressure reduction in patient with refractory glaucoma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intra Ocular Pressure (IOP) | Mean Intraocular pressure (IOP) reduction from pre operative IOP | One year |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | one year |
| Number of patients with adverse events as a measure of safety |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Prashanth Ranganath, MBBS., MS., | Contact | +91 452 4356100 | 118 | loweriop@gmail.com |
| Mr.S.Karthi Kumar, M.Pahrmacy | Contact | +91 452 4356100 | 229 | crd@aurolab.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Prashanth Ranganath, MBBS., MS., | Aravind Eye Hospital, Madurai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aravind Eye Hospital | Recruiting | Madurai | Tamil Nadu | 625020 | India |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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|
to assess the incidence of post operative adverse events |
| one year |