Early and prolonged administration of aqueous suppressants for prevention of hyperencapsulation with Ahmed Valve in refractory pediatric glaucoma.
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 94
Study Overview
Brief Summary
Eighty six eyes of eighty six children completed the 12-months follow up visits and fulfilled inclusion criteria. Baseline IOP was significantly reduced from 31.95 ± 9.1 mmHg to 18.17 ± 7.4 at 12 months (p-value < 0.05) in group A and from 32.7 ± 7.4 mmHg to 19.45 ± 6.9 at 12 months (p-value < 0.05) in group B. IOP differences among groups were statistically significant in 6, 9 and 12-month follow up visits with lower IOP in group A. in first 4 months, both groups exhibited similar rates of HEP (6 (13.3 %) eyes and 7 (17.1 %) eyes respectively at 4 months). HEP rate was significantly different between groups at 6 and 12 months (10 (22.2 %) eyes and 15 (36.6%) eyes respectively at 6-months, 14 (31.1 %) eyes and 19 (46.3%) eyes respectively at 12-months).
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 0 Day(s) to 1 Month(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients younger than 16 years and diagnosed with refractory pediatric glaucoma including congenital glaucoma, juvenile glaucoma, aphakic/Pseudophakic glaucoma and glaucoma in vitrectomized eyes
Exclusion Criteria
- •Exclusion criteria were previous AGV implantation, co-existing corneal pathology, inability to measure IOP accurately or primary tube failure.