IOP Reduction and Complications of Polymethyl Methacrylate GDD on Glaucoma Patient

Glaucoma Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04052165
• Other study ID #: Oktariana
• Status: Completed
• Phase: N/A
• Start date: July 1, 2015
• Est. completion date: August 8, 2020

Study information

• Verified date: August 2021
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 8, 2020
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma Eye

Intervention

Procedure:
• Glaucoma Implant

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Hospital	Jakarta Pusat	Jakarta

Sponsors (4)

Lead Sponsor	Collaborator
Indonesia University	Dr Cipto Mangunkusumo General Hospital, Fakultas Kedokteran Universitas Indonesia, Institut Pertanian Bogor

Country where clinical trial is conducted

Indonesia, 

References & Publications (17)

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* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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