NCT03558126

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 15, 2018

Completed
Last Updated

June 15, 2018

Status Verified

June 1, 2018

Enrollment Period

3.1 years

First QC Date

June 4, 2018

Last Update Submit

June 4, 2018

Conditions

Glaucoma, Open-Angle

Keywords

silicone tubeminiature drainage devicePOAGIOP

Outcome Measures

Primary Outcomes (1)

  • IOP

    Intraocular pressure

    3 years

Secondary Outcomes (1)

  • Number of anti-glaucoma medication

    3 years

Interventions

silicone tubeDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Glaucoma, Open-Angle

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Zhejiang Eye Hospital

Study Record Dates

First Submitted

June 4, 2018

First Posted

June 15, 2018

Study Start

March 1, 2013

Primary Completion

April 1, 2016

Study Completion

October 1, 2016

Last Updated

June 15, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share