IOP Reduction and Complications of Polymethyl Methacrylate GDD on Glaucoma Patient

IOP Reduction and Complications of Polymethyl Methacrylate Glaucoma Drainage Device on Glaucoma Patient

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma Eye
• Intervention / Treatment: Procedure: Glaucoma Implant

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta
    • Jakarta Pusat, Jakarta, Indonesia, 10430
      • Cipto Mangunkusumo Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glaucoma drainage device in glaucoma patient; GDD is inserted in glaucoma patients	Procedure: Glaucoma Implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	The complications that occurred during the follow up	during the surgery, day 1, 7, 30, 60, 90 post implantation surgery

Collaborators and Investigators

• Sponsor: Indonesia University
• Collaborators: Dr Cipto Mangunkusumo General Hospital; Fakultas Kedokteran Universitas Indonesia; Institut Pertanian Bogor
• Investigators: Principal Investigator: Virna Dwi Oktariana Asrory, PhD, Indonesia University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): August 8, 2020

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: August 8, 2019
• First Posted (Actual): August 9, 2019

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 24, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Intraocular pressure; Effectiveness; Glaucoma Drainage Device; Tissue Response
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: Oktariana

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No