IOP Reduction and Complications of Polymethyl Methacrylate GDD on Glaucoma Patient

Study Overview
=================
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.

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.

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

Conditions
-----------------
Glaucoma Eye

Intervention / Treatment
-----------------
* Procedure: Glaucoma Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: GDD in glaucoma patient
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glaucoma drainage device in glaucoma patient<br>GDD is inserted in glaucoma patients | Procedure: Glaucoma Implant<br> <br> |

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Effectiveness, Glaucoma Drainage Device, Intraocular pressure, Tissue Response