This study aims to test a new medical device, called the eyeWatch, used in filtering surgery for the treatment of glaucoma. This medical device has the following property: it allows better control of intraocular pressure in the initial postoperative phase by adjusting aqueous flow going through the device. The target criteria for the study are defined as: keeping intraocular pressure in target range; reducing the number of anti-glaucoma drugs; evaluating the number and type of postoperative complications. So far, this device has been already tested on 20 patients in Switzerland.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
The eyeWatch device is composed of an AGDD, a control unit and a draining plate
St. Thomas' Hospital
London, United Kingdom
Number and type of serious adverse device events
Demonstration of safety. The number and type of serious adverse device event per patient will be measured. Results of biomicroscopy, gonioscopy, pachymetry visual field and endothelial count will be compared to baseline.
Time frame: Follow-up: day 1, Week 1, week 2, month 1, month 2, month 3, month 6, month 12 compared to baseline
Effectiveness in reducing the intraocular pressure
Demonstration of the performance. The intraocular pressure (IOP in mmHg) will be measured at different time points to show the effective reduction compared to baseline. IOP reduced by ≥ 20% or IOP \< 21 mmHg, and no IOP \< 5 mmHg on two consecutive visits after 1 month (included)
Time frame: Follow-up: day 1, Week 1, week 2, month 1, month 2, month 3, month 6, month 12 compared to baseline
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