IOP Reduction and Complications of Polymethyl Methacrylate GDD on Glaucoma Patient

NCT04052165 — Not applicable, Completed, 150 participants, Universitas Indonesia

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

RegistryNCT04052165
StatusCompleted
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, treatment
Enrollment150 (Actual)
SponsorUniversitas Indonesia (Other); collaborators: Fakultas Kedokteran Universitas Indonesia, Dr Cipto Mangunkusumo General Hospital, Institut Pertanian Bogor
ConditionsGlaucoma Eye
InterventionsGlaucoma Implant (Procedure)
Datesstart 2015-07-01, primary completion 2019-08-01, completion 2020-08-08, first posted 2019-08-09, last updated 2021-08-25
Locations1 site in Indonesia

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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Glaucoma drainage device in glaucoma patientExperimentalProcedure: Glaucoma ImplantGDD is inserted in glaucoma patients
  • Glaucoma Implant (Procedure)

+Outcome measures

Primary outcomes

  • 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 outcomes

  • 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

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Cipto Mangunkusumo HospitalJakarta Pusat, Jakarta Special Capital RegionIndonesia

+Publications

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+Investigators