IOP Reduction and Complications of Polymethyl Methacrylate GDD on Glaucoma Patient
NCT ID: NCT04052165
Last Updated: 2021-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2015-07-01
2020-08-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Glaucoma drainage device in glaucoma patient
GDD is inserted in glaucoma patients
Glaucoma Implant
Interventions
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Glaucoma Implant
Eligibility Criteria
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Inclusion Criteria
* Patients that are willing to participate in the study
* Patients with \<6/60 visual acuity
* Patients above 18 years
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Fakultas Kedokteran Universitas Indonesia
OTHER
Dr Cipto Mangunkusumo General Hospital
OTHER
Institut Pertanian Bogor
OTHER
Indonesia University
OTHER
Responsible Party
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Dr. dr. Virna Dwi Oktariana, SpM(K)
Principal Investigator
Principal Investigators
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Virna Dwi Oktariana Asrory, PhD
Role: PRINCIPAL_INVESTIGATOR
Indonesia University
Locations
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Cipto Mangunkusumo Hospital
Jakarta Pusat, Jakarta Special Capital Region, Indonesia
Countries
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References
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Giangiacomo A, Coleman AL. The Epidemiology of Glaucoma. In: Grehn F, Stamper R, editors. Glaucoma [Internet]. Berlin, Heidelberg: Springer Berlin Heidelberg; 2009 [cited 2016 Jun 14]. p. 13-21. Available from: http://link.springer.com/10.1007/978-3-540-69475-5_2
Stamper R, Lieberman M, Drake M. Introduction and Classification of the Glaucomas. In: Becker-Shaffer's Diagnosis and Therapy of the Glaucomas. 8th ed. Mosby Elsevier; 2009. p. 1-7.
Stamper R, Drake M, Lieberman M. Primary Open Angle Glaucoma. In: Becker-Shaffer's Diagnosis and Therapy of the Glaucomas. 8th ed. Mosby Elsevier; 2009. p. 239-57
Sharaawy T, Sherwood M, Hitchings R. Glaucoma. 1st ed. Vol. 1. Philadelphia: Saunder Elsevier; 2009.
Stamper RL, Lieberman MF, Drake MV. Laser Therapy. In: Becker-Shaffer's Diagnosis and Therapy of the Glaucomas. 8th ed. USA: Elsevier Health Sciences; 2009. p. 436-8.
Stamper RL, Lieberman MF, Drake MV. Glaucoma outflow procedure. In: Becker-Shaffer's Diagnosis and Therapy of the Glaucomas. UK: Elsevier Health Sciences; 2009. p. 466-90.
Eisenberg DL, Koo EY, Hafner G, Schuman JS. In vitro flow properties of glaucoma implant devices. Ophthalmic Surg Lasers. 1999 Sep-Oct;30(8):662-7.
Koura Y, Fukushima A, Nishino K, Ishida W, Nakakuki T, Sento M, Yamazoe K, Yamaguchi T, Misyoshi T, Ueno H. Inflammatory reaction following cataract surgery and implantation of acrylic intraocular lens in rabbits with endotoxin-induced uveitis. Eye (Lond). 2006 May;20(5):606-10. doi: 10.1038/sj.eye.6701975.
Kim MS, Rhee SW. Effects on the surrounding tissues and morphological changes of components after implantation of PMMA and heparin surface modified PMMA intraocular lens in rabbit eyes. Korean J Ophthalmol. 1990 Dec;4(2):73-81. doi: 10.3341/kjo.1990.4.2.73.
Cioffi G. Basic and Clinical Science Course. 11th ed. American Academy of Ophtalmology; 2011. 211-215 p.
Wilson MR, Mendis U, Smith SD, Paliwal A. Ahmed glaucoma valve implant vs trabeculectomy in the surgical treatment of glaucoma: a randomized clinical trial. Am J Ophthalmol. 2000 Sep;130(3):267-73. doi: 10.1016/s0002-9394(00)00473-6.
Beck AD, Freedman S, Kammer J, Jin J. Aqueous shunt devices compared with trabeculectomy with Mitomycin-C for children in the first two years of life. Am J Ophthalmol. 2003 Dec;136(6):994-1000. doi: 10.1016/s0002-9394(03)00714-1.
Jung KI, Lim SA, Park HY, Park CK. Visualization of blebs using anterior-segment optical coherence tomography after glaucoma drainage implant surgery. Ophthalmology. 2013 May;120(5):978-83. doi: 10.1016/j.ophtha.2012.10.015. Epub 2013 Jan 21.
Azuara-Blanco A, Katz LJ. Dysfunctional filtering blebs. Surv Ophthalmol. 1998 Sep-Oct;43(2):93-126. doi: 10.1016/s0039-6257(98)00025-3.
Clark A, Wax M, Civan M. Mechanisms of Glaucoma. In: Ophthalmology. 3rd ed. St. Louis, Mo: Mosby Elsevier; 2014. p. 1012-8.
Chang DT, Jones JA, Meyerson H, Colton E, Kwon IK, Matsuda T, Anderson JM. Lymphocyte/macrophage interactions: biomaterial surface-dependent cytokine, chemokine, and matrix protein production. J Biomed Mater Res A. 2008 Dec 1;87(3):676-87. doi: 10.1002/jbm.a.31630.
Major MR, Wong VW, Nelson ER, Longaker MT, Gurtner GC. The foreign body response: at the interface of surgery and bioengineering. Plast Reconstr Surg. 2015 May;135(5):1489-1498. doi: 10.1097/PRS.0000000000001193.
Other Identifiers
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Oktariana
Identifier Type: -
Identifier Source: org_study_id
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