IOP Reduction and Complications of Polymethyl Methacrylate GDD on Glaucoma Patient

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04052165

Enrollment

150

Registered

2019-08-09

Start date

2015-07-01

Completion date

2020-08-08

Last updated

2021-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma Eye

Keywords

Effectiveness, Glaucoma Drainage Device, Intraocular pressure, Tissue Response

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.

Interventions

PROCEDUREGlaucoma Implant

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

GDD in glaucoma patient

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
IOP reduction of Polymethylmethacrylate Glaucoma Drainage Device in refractory Glaucoma Patients	pre implantation surgery, day 1, 7, 30, 60, 90 post implantation surgery	Intraocular pressure (IOP)

Secondary

Measure	Time frame	Description
The glaucoma medication that was used pre and post operative	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	during the surgery, day 1, 7, 30, 60, 90 post implantation surgery	The complications that occurred during the follow up

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026