Glaucoma, Open-Angle
Conditions
Keywords
silicone tube, miniature drainage device, POAG, IOP
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.
Interventions
DEVICEsilicone tube
Sponsors
yin ying zhao
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IOP | 3 years | Intraocular pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of anti-glaucoma medication | 3 years | Number of anti-glaucoma medication |
Outcome results
None listed