IOP Reduction and Complications of Polymethyl Methacrylate GDD on Glaucoma Patient

University of Indonesia (UI)

Status

Completed

Conditions

Glaucoma Eye

Treatments

Procedure: Glaucoma Implant

Study type

Interventional

Funder types

Other

Identifiers

NCT04052165

Oktariana

Details and patient eligibility

About

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 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.

Enrollment

150 patients

Sex

All

Ages

18+ years old

Volunteers

No 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