To evaluate the intraoperative stability, safety and overall efficacy of the Canabrava Ring (AJL - SPAIN) when used to expand pupils with less diameter than 5 mm and pupils with sphincter synechiae.
In this consecutive case series, 30 eyes of 29 patients underwent cataract surgery using a new disposable small-pupil expansion device, Canabrava's Ring (AJL Ophthalmic, Spain). It is the first iris expansion ring produced with indents that do not align with each other in the superior and inferior regions, resulting in a small vertical length (0.4mm) that minimizes risk of endothelial contact. All eyes had poorly preoperatively dilated pupils of less than 5mm. Fifteen eyes had significant infective or traumatic pathology preoperatively. Vertical and horizontal pupil diameters were evaluated pre-, intra- and 1 month postoperatively, and were used to calculate pupil circumference. Intraoperative and postoperative pupil circumference comprised the primary outcomes of interest.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
The device is used during cataract surgery to help dilate small pupils (under 5mm)
Incidence of adverse events
Safety of the material of the device from break, lesion of eye structures and iritis
Time frame: 30 days after surgery
Stability of the device during surgery
Evaluate whether the device remains stable and attached to the iris during the entire surgery
Time frame: During surgery
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