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Glaucoma EyeNCT04052165

IOP Reduction and Complications of Polymethyl Methacrylate GDD on Glaucoma Patient

A study testing Glaucoma Implant in people with Glaucoma Eye, run by Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glaucoma Eye
What is being tested?
Glaucoma Implant
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteIndonesia
Study dates
1 Jul 2015to 8 Aug 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Cipto Mangunkusumo Hospital

    Jakarta Pusat, Jakarta Special Capital Region, 10430

Other trials in Indonesia

About this study

Official title: 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.

Read the 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.

Conditions
Glaucoma Eye
Being tested
Glaucoma Implant
Keywords
Effectiveness, Glaucoma Drainage Device, Intraocular pressure, Tissue Response

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Glaucoma ImplantProcedure or surgery

Study groups in NCT04052165
Study groupRoleWhat they receive
Glaucoma drainage device in glaucoma patientExperimentalGDD is inserted in glaucoma patients
Receives: Procedure: Glaucoma Implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. IOP reduction of Polymethylmethacrylate Glaucoma Drainage Device in refractory Glaucoma Patients

    Intraocular pressure (IOP)

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

Secondary outcomes (2)

  1. The glaucoma medication that was used pre and post operative

    The glaucoma medication used pre and post op

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

  2. The complications that occurred during the follow up

    The complications that occurred during the follow up

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2019
  2. Study start1 Jul 2015
  3. Primary completion1 Aug 2019
  4. Study completion8 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
GDD in glaucoma patient
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04052165
Sponsor's protocol ID
Oktariana
Status last verified
Aug 2021
First submitted
6 Aug 2019
Last updated
25 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 10507569

  • 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.

    PubMed 15999134

  • 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.

    PubMed 2092164

  • 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.

    PubMed 11020403

  • 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.

    PubMed 14644208

  • 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.

    PubMed 23347982

  • 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.

    PubMed 9763136

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

Questions about this trial

What is this clinical trial studying?

A study testing Glaucoma Implant in people with Glaucoma Eye, run by Universitas Indonesia at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IOP reduction of Polymethylmethacrylate Glaucoma Drainage Device in refractory Glaucoma Patients (time frame: pre implantation surgery, day 1, 7, 30, 60, 90 post implantation surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04052165, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.

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