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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date August 2021
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Glaucoma Implant


Locations

Country Name City State
Indonesia Cipto Mangunkusumo Hospital Jakarta Pusat Jakarta

Sponsors (4)

Lead Sponsor Collaborator
Indonesia University Dr Cipto Mangunkusumo General Hospital, Fakultas Kedokteran Universitas Indonesia, Institut Pertanian Bogor

Country where clinical trial is conducted

Indonesia, 

References & Publications (17)

Azuara-Blanco A, Katz LJ. Dysfunctional filtering blebs. Surv Ophthalmol. 1998 Sep-Oct;43(2):93-126. Review. — View Citation

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. — View Citation

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. — View Citation

Cioffi G. Basic and Clinical Science Course. 11th ed. American Academy of Ophtalmology; 2011. 211-215 p.

Clark A, Wax M, Civan M. Mechanisms of Glaucoma. In: Ophthalmology. 3rd ed. St. Louis, Mo: Mosby Elsevier; 2014. p. 1012-8.

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Sharaawy T, Sherwood M, Hitchings R. Glaucoma. 1st ed. Vol. 1. Philadelphia: Saunder Elsevier; 2009.

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

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 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.

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.

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. — View Citation

* Note: There are 17 references in allClick here to view all references

Outcome

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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