STARflo TM Glaucoma Implant Clinical Experience Program in Real-World
Research type
Research Study
Full title
STARflo Glaucoma lmplant Clinical Experience Program in a Real-World Patient Population
IRAS ID
210300
Contact name
Marie-Claude MAUBREY
Contact email
Sponsor organisation
iSTAR Medical
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
The aim of this Clinical Experience Program is to document patient’s benefit following implantation of the STARflo Implant in patients treated in a day to day clinical setting and to learn about surgical practices.
This Clinical Experience Program is being initiated to expand the surgical and clinical practice knowledge about the use of STARflo for reducing intraocular pressure (lOP) in a “real world" population of patient.
Patients suffering from open angle glaucoma or in some cases of narrow angle glaucoma (as per instruction for use (IFU)) and implanted with STARflo within five past years, will be eligible for this research.
This Clinical Experience Program is open to any investigative site willing to contribute and approved to do so as per local regulation. Investigator selected to participate to this program must have implanted at least one STARflo in indicated population.
Patient data will be collected retrospectively or prospectively after patient’s signed approval to do so.
This research is designed as a registry program. Therefore participating patients will not undergo any intervention in addition of standard practice exams. This research plans to collect effectiveness of STARflo implant, surgery complications and medical device related adverse events over a period of 60 months after participating patient’s implantation surgery.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
16/LO/1461
Date of REC Opinion
12 Oct 2016
REC opinion
Further Information Favourable Opinion