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Completed

NCT Number: NCT04052165

IOP Reduction and Complications of Polymethyl Methacrylate GDD 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.

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Key information

Conditions

Glaucoma Eye

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Hospital

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glaucoma Implant

Procedure

Primary outcomes

  1. 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

    Intraocular pressure (IOP)

Secondary outcomes

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

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

    The glaucoma medication used pre and post op

  2. The complications that occurred during the follow up

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

    The complications that occurred during the follow up

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Collaborators

  • Dr Cipto Mangunkusumo General Hospital
  • Fakultas Kedokteran Universitas Indonesia
  • Institut Pertanian Bogor

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Aug 9, 2019
Registry last updated
Aug 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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