IOP Reduction and Complications of Polymethyl Methacrylate GDD on Glaucoma Patient

Overview

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.

Full Title of Study: “IOP Reduction and Complications of Polymethyl Methacrylate Glaucoma Drainage Device on Glaucoma Patient”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: August 1, 2019

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.

Interventions

• Procedure: Glaucoma Implant

Arms, Groups and Cohorts

• Experimental: Glaucoma drainage device in glaucoma patient
  • GDD is inserted in glaucoma patients

Clinical Trial Outcome Measures

Primary Measures

• 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 Measures

• 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
• 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Indonesia University
• Collaborator
  • Fakultas Kedokteran Universitas Indonesia
• Provider of Information About this Clinical Study
  • Principal Investigator: Dr. dr. Virna Dwi Oktariana, SpM(K), Principal Investigator – Indonesia University
• Overall Official(s)
  • Virna Dwi Oktariana Asrory, PhD, Principal Investigator, Indonesia University

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