The confirm the performance and safety of the eyeWatch System as first-line filtering surgery and compare its outcomes to trabeculectomy
Open-angle glaucoma is an ophthalmic disease often characterised by high intraocular pressures. Traditionally, glaucoma is treated using medication, however, more advanced or refractory glaucoma requires surgical treatment. In terms of surgery, the current gold-standard is trabeculectomy. Despite good efficacy, the technique carries relatively high rates of complications. The eyeWatch system has recently received CE-marking for the treatment of open-angle glaucoma. During its initial clinical trial, the eyeWatch system demonstrated good safety and efficacy profile. The present randomized control trial will assess its safety and efficacy against the current gold-standard: trabeculectomy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
The eyeWatch system will be implanted as per the manufacturer's instruction, and trabeculectomy will be performed using mitomycin C as per standard surgical protocols.
SwissVisio Montchoisi
Lausanne, Canton of Vaud, Switzerland
Intraocular pressure (mmHg)
The primary endpoint will be the change in intraocular pressure (mmHg) from pre-operative baseline to 12-month post-operatively. Intraocular pressure will be measure at each visit using Goldmann tonometry. Baseline intraocular pressure will be defined as the mean of the last two pre-operative measurements.
Time frame: pre-op to month 12
number of anti glaucoma medications
The number of anti-glaucoma medications will be reported for each visit and compared to the baseline.
Time frame: pre-op to month 12
Visual acuity
Visual acuity will be measured at each visit and compared to the baseline measurement.
Time frame: baseline to month 12
visual field mean deviation
Visual field mean deviation will be measured at each visit and compared to the baseline measurement.
Time frame: baseline to month 12
endothelial cell density
the number of endothelial cells will be measured at each visit and compared to the baseline measurement.
Time frame: baseline to month 12
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