First, to compare safety and effectiveness outcomes for canaloplasty and trabeculotomy using the OMNI Surgical System to implantation of the iStent inject in lowering intraocular pressure (IOP) in pseudophakic eyes with open angle glaucoma (OAG), and second, to compare safety and effectiveness outcomes for canaloplasty alone (using the OMNI Surgical System)to implantation of the iStent Inject in lowering IOP in pseudophakic eyes with OAG.
A multicenter, prospective, parallel group study planned to randomize 459 subjects to either 1)canaloplasty + trabeculotomy with the OMNI, 2)canaloplasty alone with the OMNI, or 3)iStent inject in an equal allocation ratio (1:1:1); The study includes baseline and terminal (Month 12) washout. Up to 26 centers in the UK and EU were planned to participate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Ab-interno canaloplasty (360 degrees) and up to 360 degrees trabeculotomy
Ab-interno implantation of iStent inject (2 microstents)
Ab-interno canaloplasty (360 degrees) using the OMNI
BurgerHospital
Frankfurt, Germany
Institut Catala de Retina (ICR)
Barcelona, Spain
Universidad Complutense de Madrid
Valencia, Spain
Paseo Isabel la Católica 1-3. Edificio general Hospital Miguel Servet. Planta calle
Zaragoza, Spain
Mean Change in Unmedicated DIOP From Baseline at the 12-month Postoperative Examination
Mean change in unmedicated DIOP from baseline at the 12-month postoperative examination is the mean of the difference between the baseline DIOP and the Month 12 DIOP for each subject. Baseline and Month 12 DIOP are measured after appropriate washout of any glaucoma medications.
Time frame: 12 months
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Manchester Royal Eye Hospital
Manchester, United Kingdom