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出境医 / 临床实验 / Silicone Tube for the Surgical Treatment of Glaucoma
Silicone Tube for the Surgical Treatment of Glaucoma
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Glaucoma, Open-Angle | Device: silicone tube | Not Applicable |
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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 36 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Silicone Tube Miniature Drainage Device Implanted Under Scleral Flap for the Surgical Treatment of Glaucoma |
| Actual Study Start Date : | March 1, 2013 |
| Actual Primary Completion Date : | April 1, 2016 |
| Actual Study Completion Date : | October 1, 2016 |
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
- IOP [ Time Frame: 3 years ]Intraocular pressure
Secondary Outcome Measures :
- Number of anti-glaucoma medication [ Time Frame: 3 years ]Number of anti-glaucoma medication
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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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Contacts and Locations
No Contacts or Locations Provided
| Tracking Information | |||
|---|---|---|---|
| First Submitted Date ICMJE | June 4, 2018 | ||
| First Posted Date ICMJE | June 15, 2018 | ||
| Last Update Posted Date | June 15, 2018 | ||
| Actual Study Start Date ICMJE | March 1, 2013 | ||
| Actual Primary Completion Date | April 1, 2016 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
IOP [ Time Frame: 3 years ] Intraocular pressure
|
||
| Original Primary Outcome Measures ICMJE | Same as current | ||
| Change History | No Changes Posted | ||
| Current Secondary Outcome Measures ICMJE |
Number of anti-glaucoma medication [ Time Frame: 3 years ] Number of anti-glaucoma medication
|
||
| Original Secondary Outcome Measures ICMJE | Same as current | ||
| Current Other Pre-specified Outcome Measures | Not Provided | ||
| Original Other Pre-specified Outcome Measures | Not Provided | ||
| Descriptive Information | |||
| Brief Title ICMJE | Silicone Tube for the Surgical Treatment of Glaucoma | ||
| Official Title ICMJE | Silicone Tube Miniature Drainage Device Implanted Under Scleral Flap for the Surgical Treatment of Glaucoma | ||
| 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. | ||
| Study Type ICMJE | Interventional | ||
| Study Phase ICMJE | Not Applicable | ||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||
| Condition ICMJE | Glaucoma, Open-Angle | ||
| Intervention ICMJE | Device: silicone tube | ||
| Study Arms ICMJE | Not Provided | ||
| Publications * | Not Provided | ||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Completed | ||
| Actual Enrollment ICMJE |
36 | ||
| Original Actual Enrollment ICMJE | Same as current | ||
| Actual Study Completion Date ICMJE | October 1, 2016 | ||
| Actual Primary Completion Date | April 1, 2016 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE |
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. - |
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers ICMJE | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | Not Provided | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT03558126 | ||
| Other Study ID Numbers ICMJE | NL-HZ-tube | ||
| Has Data Monitoring Committee | Yes | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE |
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| Responsible Party | yin ying zhao, Wenzhou Medical University | ||
| Study Sponsor ICMJE | yin ying zhao | ||
| Collaborators ICMJE | Not Provided | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | Wenzhou Medical University | ||
| Verification Date | June 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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