Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT05044793 - A Clinical Study To Assess The Safety And Effectiveness Of The OMNI® Surgical System
Recruiting NCT06201455 - Evaluation of Phacogoniotomy in Medically-controlled POAG N/A
Recruiting NCT03369886 - The Relationship Between Macular OCTA and GCIPL and Their Combinational Index Using AI N/A
Active, not recruiting NCT04624698 - iStent Inject New Enrollment Post-Approval Study N/A
Recruiting NCT02679482 - Following Patients After Selective and Pascal Laser Trabeculoplasty for Treatment of Chronic Open-Angle Glaucoma N/A
Completed NCT02338362 - Inhaled Corticosteroids: Effect on Intraocular Pressure in Patients With Controlled Glaucoma Phase 4
Active, not recruiting NCT01430923 - Clinical Evaluation of Safety and Efficacy of Refrigeration Free Latanoprost N/A
Completed NCT01489670 - Observational Study of Lumigan® 0.01% Treatment for Patients With Primary Open Angle Glaucoma or Ocular Hypertension N/A
Completed NCT00693485 - Safety and Effects of Brimonidine Intravitreal Implant in Patients With Glaucomatous Optic Neuropathy Phase 2
Completed NCT00753168 - Phase 1-2 Evaluation of OT-730 Eye Drops in Reducing the Intraocular Pressure in Patients With Ocular Hypertension or Open-Angle Glaucoma Phase 1/Phase 2
Completed NCT00051194 - A 6-week Safety & Efficacy Study of Combination Intraocular Pressure-lowering Therapy in Patients With Open-angle Glaucoma or Ocular Hypertension Phase 2
Recruiting NCT04920227 - Comparation of CLASS Combined With Phacoemulsification and CLASS Alone in the Treatment of Primary Open Angle Glaucoma N/A
Active, not recruiting NCT03868124 - Clinical Study Comparing Two Models of a Travoprost Intraocular Implant Phase 3
Completed NCT03267862 - Scleral Response to Intraocular Pressure (IOP) N/A
Recruiting NCT06066645 - Travoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone Phase 3
Recruiting NCT04912362 - The Effectiveness of YAG Iridotomy in Preventing Peripheral Anterior Synechia After CLASS in Primary Open Angle Glaucoma N/A
Completed NCT04949802 - Glaucoma Surgery Using the ViaLase Laser System N/A
Recruiting NCT04038034 - Valuation of the Antioxidant and Neuroprotective Effects of CoQ10-MINIACTIVES® (COQUN® OS) in Patients Affected by Primary Open Angle Glaucoma N/A
Completed NCT04632329 - Negative Pressure Applied by the Equinox MPD for Severe Open Angle Glaucoma N/A
Completed NCT01215786 - Safety and Pharmacodynamics Study of AGN-207281 Ophthalmic Solutions Compared With Timolol Ophthalmic Solution or Placebo in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma Phase 1