Back to resultsSilicone Tube for the Surgical Treatment of Glaucoma
Primary Purpose
Glaucoma, Open-Angle
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
silicone tube
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Open-Angle focused on measuring silicone tube, miniature drainage device, POAG, IOP
Eligibility Criteria
Inclusion Criteria:Eligible patients were at least 18 years of age and presented with medically uncontrolled POAG requiring incisional surgery for IOP (intraocular pressure) reduction.
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Exclusion Criteria:Exclusion criteria included narrow angles, normal tension glaucoma, previous eye surgery (except cataract surgery), neovascular glaucoma, uveitis, any ocular abnormality that would preclude accurate IOP assessment, and inability to comply with the follow-up program or unwillingness to participate in this study.
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Sites / Locations
Outcomes
Primary Outcome Measures
IOP
Intraocular pressure
Secondary Outcome Measures
Number of anti-glaucoma medication
Number of anti-glaucoma medication
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03558126
Brief Title
Silicone Tube for the Surgical Treatment of Glaucoma
Official Title
Silicone Tube Miniature Drainage Device Implanted Under Scleral Flap for the Surgical Treatment of Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2013 (Actual)
Primary Completion Date
April 1, 2016 (Actual)
Study Completion Date
October 1, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
yin ying zhao
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The biocompatible silicone tube miniature drainage device is a small, non-valved implant to shunt aqueous humor underneath the conjunctiva to control the intraocular pressure. Efficacy and safety were evaluated with a minimum follow-up of 12 months.
Detailed Description
Patients were examined postoperatively at 1 day, 1 week, 1, 3, 6, 12, 18, 24 months or more frequent when required. IOP, BCVA and slit lamp biomicroscopy were observed at every visit. History of all medication details and postoperative complications were recorded. One-way analysis of variance (ANOVA) with repeated measures was used to analyze the other differences over time in IOP and BCVA. Nonparametric K-related samples test was used to analyze the difference of medications number at different time points. Success rates were evaluated using Kaplan-Meyer survival analysis curves.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle
Keywords
silicone tube, miniature drainage device, POAG, IOP
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
silicone tube
Primary Outcome Measure Information:
Title
IOP
Description
Intraocular pressure
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Number of anti-glaucoma medication
Description
Number of anti-glaucoma medication
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:Eligible patients were at least 18 years of age and presented with medically uncontrolled POAG requiring incisional surgery for IOP (intraocular pressure) reduction.
-
Exclusion Criteria:Exclusion criteria included narrow angles, normal tension glaucoma, previous eye surgery (except cataract surgery), neovascular glaucoma, uveitis, any ocular abnormality that would preclude accurate IOP assessment, and inability to comply with the follow-up program or unwillingness to participate in this study.
-
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Silicone Tube for the Surgical Treatment of Glaucoma
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