Clinical trial NCT04052165: IOP Reduction and Complications of Polymethyl Methacrylate GDD on Glaucoma Patient
Official title: IOP Reduction and Complications of Polymethyl Methacrylate Glaucoma Drainage Device on Glaucoma Patient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma Eye
Keywords: Effectiveness
Glaucoma Drainage Device
Intraocular pressure
Tissue Response
Lead sponsor: Indonesia University
Sponsor class: OTHER
Collaborators: name: Fakultas Kedokteran Universitas Indonesia
name: Dr Cipto Mangunkusumo General Hospital
name: Institut Pertanian Bogor
First posted: 2019-08-09
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: GDD in glaucoma patient
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: IOP reduction of Polymethylmethacrylate Glaucoma Drainage Device in refractory Glaucoma Patients
timeFrame: pre implantation surgery, day 1, 7, 30, 60, 90 post implantation surgery
Secondary outcomes:
measure: The glaucoma medication that was used pre and post operative
timeFrame: pre implantation surgery, day 1, 7, 30, 60, 90 post implantation surgery
measure: The complications that occurred during the follow up
timeFrame: during the surgery, day 1, 7, 30, 60, 90 post implantation surgery
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Cipto Mangunkusumo Hospital
state: Jakarta
Study officials:
affiliation: Indonesia University
name: Virna Dwi Oktariana Asrory, PhD
role: PRINCIPAL_INVESTIGATOR
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