To establish the clinical performance of the SOLX Gold Shunt for its ability to reduce intraocular pressure (IOP) in eyes with refractory glaucoma where medical and conventional surgical treatments have failed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
116
Single use implant
University of Alabama
Birmingham, Alabama, United States
Vold Vision, PLLC
Springdale, Arkansas, United States
Proportion of eyes that achieve an IOP of > 5mmHg and ≤ 21 mmHg, irrespective of medication use
Time frame: 1 year
Average change in IOP
Time frame: 1 & 2 years
Percentage change in IOP from baseline
Time frame: 1 & 2 years
Average change in number of glaucoma medications
Time frame: 1 & 2 years
Visual acuity changes
Time frame: 1 & 2 years
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