STARVI MINIject Implant for subject with cataract and glaucoma
Research type
Research Study
Full title
A PROSPECTIVE, OPEN, MULTICENTER CLINICAL TRIAL EVALUATING THE EFFICACY AND SAFETY OF MINIJECT INTEGRATED SYSTEM CS627 COMBINED WITH CATARACT SURGERY IN PATIENTS WITH OPEN ANGLE GLAUCOMA UNCONTROLLED BY TOPICAL HYPOTENSIVE MEDICATIONS AND OPERABLE AGE-RELATED CATARACT DIAGNOSIS
IRAS ID
316754
Contact name
Mahmoud Radwan
Contact email
Sponsor organisation
ISTAR Medical
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 2 days
Research summary
Glaucoma is a complex 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 the eye. 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 the 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.
The MINI SO627 consists of a small implant made of 100% medical grade silicone and a delivery tool and has received CE-mark when implanted standalone. This study will evaluate the safety and efficacy when MINIject is used in combination with cataract surgery.
The cataract surgery will be performed first and, if successful, the MINIject implant will be placed into the area under the white part of the eye inside one of the eyes and remain there after completion of the clinical trial.
Eligible patients will be males and females, 40 years of age or older, who have both POAG and an operable age-related cataract in one of the eyes, and without any other form of glaucoma in the study eye and prior glaucoma surgery usign a draining device.
The study will take place in 8 sites accross Europe,UK, Canada and Panama, with two NHS hospital in the UK - Colchester Hospital in Colchester and NHS Lothian in Edinburgh.
Eligible subjects who agree to participate will undergo cataract surgery and implantation of the MINI SO627 in the study eye and will be followed up for 24 months after surgery with at least 7 postoperative visits.REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
22/WM/0165
Date of REC Opinion
13 Sep 2022
REC opinion
Further Information Favourable Opinion