MAGIC, version 3.0
Research type
Research Study
Full title
MULTICENTER GLAUCOMA STUDY INVESTIGATING STANDALONE CANALOPLASTY (MAGIC)
IRAS ID
321992
Contact name
Andrew Tatham
Contact email
Sponsor organisation
Nova Eye Medical
Duration of Study in the UK
1 years, 7 months, 2 days
Research summary
Glaucoma is an eye disease characterized by progressive and irreversible vision loss due to optic nerve damage, caused by fluid building up and creating pressure inside the eye. Primary open angle glaucoma (POAG) is the most common type of glaucoma.
Nova Eye Medical, the study Sponsor commercializes a device called the iTrack Advance, which uses microcatheter technology to expand the eye’s drainage channels to lower eye pressure and reduce the number of glaucoma medications needed. It is an implant-free, tissue sparing procedure that acts to re-establish the function of the eye's natural drainage system.
This study will assess how well the iTrack Advance is able to lower eye pressure and reduce medications, and its efficacy will be compared to another canaloplasty device called OMNI. Both devices are part of a group of surgeries called Minimally Invasive Glaucoma Surgery (MIGS) as they cause no major disruption to the eye tissue and require minimal post-operative recovery.
The study will take place in up to 6 sites across UK & Europe with three NHS hospitals in the UK, in Edinburgh, Manchester and Liverpool.
Eligible patients will be males and females, 22 years of age or older, diagnosed with POAG, on less than 4 glaucoma medications, and without prior glaucoma surgery using a drainage device, and without other significant ocular diseases.
Eligible subjects who agree to participate will undergo canaloplasty with either the iTrack Advance or the OMNI, and will be followed up for 12 months after surgery, with at least 7 postoperative visits. Only one eye of each participant will be treated. The decision as to which procedure patients will receive (iTrack Advance or OMNI) is randomized, meaning that it is selected by chance, like tossing a coin (50% chance for each). Patients will not know which group they are in until study exit.REC name
South East Scotland REC 01
REC reference
23/SS/0014
Date of REC Opinion
16 Mar 2023
REC opinion
Further Information Favourable Opinion