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IOP Reduction and Complications of Polymethyl Methacrylate GDD on Glaucoma Patient

Primary Purpose

Glaucoma Eye

Status
Completed
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Glaucoma Implant
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma Eye focused on measuring Effectiveness, Glaucoma Drainage Device, Intraocular pressure, Tissue Response

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cipto Mangunkusumo Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Glaucoma drainage device in glaucoma patient

Arm Description

GDD is inserted in glaucoma patients

Outcomes

Primary Outcome Measures

IOP reduction of Polymethylmethacrylate Glaucoma Drainage Device in refractory Glaucoma Patients
Intraocular pressure (IOP)

Secondary Outcome Measures

The glaucoma medication that was used pre and post operative
The glaucoma medication used pre and post op
The complications that occurred during the follow up
The complications that occurred during the follow up

Full Information

First Posted
August 6, 2019
Last Updated
August 24, 2021
Sponsor
Indonesia University
Collaborators
Fakultas Kedokteran Universitas Indonesia, Dr Cipto Mangunkusumo General Hospital, Institut Pertanian Bogor
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1. Study Identification

Unique Protocol Identification Number
NCT04052165
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2015 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University
Collaborators
Fakultas Kedokteran Universitas Indonesia, Dr Cipto Mangunkusumo General Hospital, Institut Pertanian Bogor

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma Eye
Keywords
Effectiveness, Glaucoma Drainage Device, Intraocular pressure, Tissue Response

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
GDD in glaucoma patient
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glaucoma drainage device in glaucoma patient
Arm Type
Experimental
Arm Description
GDD is inserted in glaucoma patients
Intervention Type
Procedure
Intervention Name(s)
Glaucoma Implant
Primary Outcome Measure Information:
Title
IOP reduction of Polymethylmethacrylate Glaucoma Drainage Device in refractory Glaucoma Patients
Description
Intraocular pressure (IOP)
Time Frame
pre implantation surgery, day 1, 7, 30, 60, 90 post implantation surgery
Secondary Outcome Measure Information:
Title
The glaucoma medication that was used pre and post operative
Description
The glaucoma medication used pre and post op
Time Frame
pre implantation surgery, day 1, 7, 30, 60, 90 post implantation surgery
Title
The complications that occurred during the follow up
Description
The complications that occurred during the follow up
Time Frame
during the surgery, day 1, 7, 30, 60, 90 post implantation surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Virna Dwi Oktariana Asrory, PhD
Organizational Affiliation
Indonesia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cipto Mangunkusumo Hospital
City
Jakarta Pusat
State/Province
Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No
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IOP Reduction and Complications of Polymethyl Methacrylate GDD on Glaucoma Patient

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