Silicone Tube for the Surgical Treatment of Glaucoma

June 4, 2018 updated by: yin ying zhao

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IOP
Time Frame: 3 years
Intraocular pressure
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of anti-glaucoma medication
Time Frame: 3 years
Number of anti-glaucoma medication
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

yin ying zhao

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

June 4, 2018

First Submitted That Met QC Criteria

June 4, 2018

First Posted (Actual)

June 15, 2018

Study Record Updates

Last Update Posted (Actual)

June 15, 2018

Last Update Submitted That Met QC Criteria

June 4, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL-HZ-tube

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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