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| Name | Class |
|---|---|
| Fakultas Kedokteran Universitas Indonesia | OTHER |
| Dr Cipto Mangunkusumo General Hospital | OTHER |
| Institut Pertanian Bogor | OTHER |
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Glaucoma is a group of diseases that damage the eye's optic nerve, result in progressive visual field defect and blindness. The aim of glaucoma management is to reduce IOP, and glaucoma implant surgery is the alternative treatment that can be chosen. The effectiveness of the implant on the end stage glaucoma patients was evaluated by the reduction of intra ocular pressure (IOP) and well formed blebs that were evaluated clinically and by using anterior scanning optical coherence tomography (AS-OCT). The safety of the implant was determined by the regression of the clinical symptoms and there were no severe complications such as implant extrusion. Two patients developed improvement of the visual acuity. This was an unpredictable positive result.
The study is to measure the efficacy of new GDD that made with polymethyl methacrylate. The primary outcome is IOP reduction. The secondary outcome is glaucoma medication post surgery and complication that occurred during the follow up. The subjects are refractory glaucoma patients that need glaucoma drainage device implantation. The measurement are collected on first day, first month, third month, sixth month and twelve month. The IOP will be measured using GAT (Goldmann applanation tonometer), but if the subjects are not cooperative, they will be measured using i-care. On the follow up, the glaucoma medication needed will be noted and also for the complication and the need for other surgery, e.g. AC formation using viscoelastic, repair tube/plate exposure, cyclo photocoagulation, etc.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glaucoma drainage device in glaucoma patient | Experimental | GDD is inserted in glaucoma patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glaucoma Implant | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| IOP reduction of Polymethylmethacrylate Glaucoma Drainage Device in refractory Glaucoma Patients | Intraocular pressure (IOP) | pre implantation surgery, day 1, 7, 30, 60, 90 post implantation surgery |
| Measure | Description | Time Frame |
|---|---|---|
| The glaucoma medication that was used pre and post operative | The glaucoma medication used pre and post op | pre implantation surgery, day 1, 7, 30, 60, 90 post implantation surgery |
| The complications that occurred during the follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Virna Dwi Oktariana Asrory, PhD | Indonesia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cipto Mangunkusumo Hospital | Jakarta Pusat | Jakarta Special Capital Region | 10430 | Indonesia |
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| ID | Term |
|---|---|
| D020327 | Glaucoma Drainage Implants |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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GDD in glaucoma patient
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The complications that occurred during the follow up
| during the surgery, day 1, 7, 30, 60, 90 post implantation surgery |
| Background |
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| Background | Clark A, Wax M, Civan M. Mechanisms of Glaucoma. In: Ophthalmology. 3rd ed. St. Louis, Mo: Mosby Elsevier; 2014. p. 1012-8. |
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