Glaucoma, Open-AngleNCT03558126
Silicone Tube for the Surgical Treatment of Glaucoma
A study testing silicone tube in people with Glaucoma, Open-Angle, run by yin ying zhao.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Open-Angle
- What is being tested?
- silicone tube
- Type of treatment
- Medical device
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2013to 1 Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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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About this study
Official title: 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.
Read the 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.
- Conditions
- Glaucoma, Open-Angle
- Being tested
- silicone tube
- Keywords
- silicone tube, miniature drainage device, POAG, IOP
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silicone tubeDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP
Intraocular pressure
Measured: 3 years
Secondary outcomes (1)
Number of anti-glaucoma medication
Number of anti-glaucoma medication
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start1 Mar 2013
- Primary completion1 Apr 2016
- Study completion1 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- yin ying zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, yin ying zhao, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03558126
- Sponsor's protocol ID
- NL-HZ-tube
- Status last verified
- Jun 2018
- First submitted
- 4 Jun 2018
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silicone Tube Miniature Drainage Device Implanted Under Scleral Flap for the Surgical Treatment of Glaucoma
- ClinicalTrials.gov ID
- NCT03558126
- Acronym / sponsor ID
- NL-HZ-tube
- Conditions
- Glaucoma, Open-Angle
- Keywords
- silicone tube, miniature drainage device, POAG, IOP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- yin ying zhaoUniversity, hospital or other
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 1 Apr 2016 (actual)
- Study completion
- 1 Oct 2016 (actual)
- First posted
- 15 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| silicone tube | Device | – |
Primary outcome
IOP
Time frame: 3 years
Intraocular pressure
1 secondary outcome
Number of anti-glaucoma medication
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing silicone tube in people with Glaucoma, Open-Angle, run by yin ying zhao.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOP (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2018.