IOP Reduction and Complications of Polymethyl Methacrylate GDD on Glaucoma Patient

NCT04052165 | Completed DMC

• 1 other identifier: Oktariana
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glaucoma Eye

Keywords

Effectiveness; Glaucoma Drainage Device; Intraocular pressure; Tissue Response

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• The glaucoma medication that was used pre and post operative

  pre implantation surgery, day 1, 7, 30, 60, 90 post implantation surgery

• The complications that occurred during the follow up

  during the surgery, day 1, 7, 30, 60, 90 post implantation surgery

Study Arms (1)

Glaucoma drainage device in glaucoma patient

EXPERIMENTAL

GDD is inserted in glaucoma patients

Procedure: Glaucoma Implant

Interventions

Glaucoma Implant PROCEDURE

Glaucoma drainage device in glaucoma patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead
• Fakultas Kedokteran Universitas Indonesia: collaborator
• Dr Cipto Mangunkusumo General Hospital: collaborator
• Institut Pertanian Bogor: collaborator

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

Location

Related Publications (17)

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  BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 10507569 BACKGROUND

• 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.

  PMID: 15999134 BACKGROUND

• 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.

  PMID: 2092164 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 11020403 BACKGROUND

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  PMID: 14644208 BACKGROUND

• 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.

  PMID: 23347982 BACKGROUND

• 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.

  PMID: 9763136 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 18200554 BACKGROUND

• 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.

  PMID: 25919260 BACKGROUND

MeSH Terms

Interventions

Glaucoma Drainage Implants

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Virna Dwi Oktariana Asrory, PhD

  Indonesia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: GDD in glaucoma patient

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 9, 2019
• Study Start: July 1, 2015
• Primary Completion: August 1, 2019
• Study Completion: August 8, 2020
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)