Glaucoma Eye Clinical Trial
Official title:
IOP Reduction and Complications of Polymethyl Methacrylate Glaucoma Drainage Device on Glaucoma Patient
NCT number | NCT04052165 |
Other study ID # | Oktariana |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2015 |
Est. completion date | August 8, 2020 |
Verified date | August 2021 |
Source | Indonesia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | August 8, 2020 |
Est. primary completion date | August 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - End stage glaucoma patients whose IOP is failed to be controlled by glaucoma medications - Patients that are willing to participate in the study - Patients with <6/60 visual acuity - Patients above 18 years Exclusion Criteria: - Patients with combination surgery indication (eg. glaucoma with cataracts) - Eyes with congenital disease of anterior segment dysgenesis - Eyes with uneven surface of the cornea that the measurement IOP with Goldmann tonometer could be difficult - Eyes with broad conjungtival cicatrix that are impossible to be implanted |
Country | Name | City | State |
---|---|---|---|
Indonesia | Cipto Mangunkusumo Hospital | Jakarta Pusat | Jakarta |
Lead Sponsor | Collaborator |
---|---|
Indonesia University | Dr Cipto Mangunkusumo General Hospital, Fakultas Kedokteran Universitas Indonesia, Institut Pertanian Bogor |
Indonesia,
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | The complications that occurred during the follow up | The complications that occurred during the follow up | during the surgery, day 1, 7, 30, 60, 90 post implantation surgery |
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