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NCT03558126 Clinical Trial

Silicone Tube for the Surgical Treatment of Glaucoma

Glaucoma, Open-Angle Clinical Trial

Official title:
Silicone Tube Miniature Drainage Device Implanted Under Scleral Flap for the Surgical Treatment of Glaucoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03558126
Other study ID # NL-HZ-tube
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2013
Est. completion date October 1, 2016

Study information
Verified date June 2018
Source Wenzhou Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date October 1, 2016
Est. primary completion date April 1, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• silicone tube

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
yin ying zhao

Outcome
Type Measure Description Time frame Safety issue
Primary IOP Intraocular pressure 3 years
Secondary Number of anti-glaucoma medication Number of anti-glaucoma medication 3 years
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