ISM06 (STAR-V): MINIject implant in subjects with open angle glaucoma
Research type
Research Study
Full title
A PROSPECTIVE, MULTICENTER MASKED CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFECTIVENESS OF THE MINIJECT CS627 IMPLANT IN SUBJECTS WITH OPEN ANGLE GLAUCOMA
IRAS ID
313514
Contact name
K Sheng Lim
Contact email
Sponsor organisation
iSTAR Medical, Inc
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Glaucoma is a complicated eye disease which results in damage to the optic nerve and leads to progressive and irreversible vision loss caused by fluid building up and creating pressure inside your eye(s). It is the leading cause for irreversible visual impairment. Primary open angle glaucoma (POAG) is the most common type of glaucoma.
iSTAR Medical, the Sponsor of this study, has developed a new device called the MINIject SO Integrated System CS627, which is intended to drain the fluid inside your eye (the aqueous humour) and provide a controlled outflow of this fluid into the back of your eye, resulting in a reduction of the intraocular pressure. It is classified as minimally invasive glaucoma surgery procedures.
This study will evaluate how well the MINI SO627 is able to lower eye pressure. The MINI SO627 consists of a small implant made of 100% medical grade silicone and a delivery tool. The implant will be placed into the area under the white part of the eye inside one of your eyes and remain there after completion of the clinical trial. The implant is made of a porous material which aims to increase the movement of fluid out of the front of the eye to the surrounding tissue. This higher fluid flow can reduce your eye pressure.
Eligible patients will be males and females, 46 years of age or older, diagnosed with POAG and with prior uncomplicated cataract surgery, on less than 4 glaucoma medications, and without prior glaucoma surgery using a drainage device, and without other significant ocular diseases.
The study will take place in 5 sites across Europe, UK and Switzerland, with one NHS hospital in the UK at St Thomas Hospital, in London.
Eligible subjects who agree to participate will undergo implantation of the MINI SO627 in the study eye – only eye of each participant will be treated – and will be followed up for 48 months after surgery to continue to assess the safety and performance of the device, with at least 10 postoperative visits.REC name
London - Dulwich Research Ethics Committee
REC reference
22/LO/0282
Date of REC Opinion
21 Jun 2022
REC opinion
Further Information Favourable Opinion