NCT04052165

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glaucoma Eye

Interventions

Type	Name	Description
PROCEDURE	Glaucoma Implant

Timeline

• Start date: 2015-07-01
• Primary completion: 2019-08-01
• Completion: 2020-08-08
• First posted: 2019-08-09
• Last updated: 2021-08-25

Locations

1 site across 1 country: Indonesia