Hydrus FRONTIER, CP 20-002, Rev 10-2021
Research type
Research Study
Full title
THE HYDRUS® MICROSTENT FOR IOP REDUCTION IN MILD TO MODERATE OPEN-ANGLE GLAUCOMA (FRONTIER)
IRAS ID
312864
Contact name
Andrew Tatham
Contact email
Sponsor organisation
Ivantis, Inc.
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 8 months, 31 days
Research summary
The objective of this study is to assess the safety and effectiveness of the Hydrus Microstent for lowering intraocular pressure in pseudophakic patients with open-angle glaucoma for whom intraocular pressure (IOP) is not adequately controlled on topical hypotensive medications.
The study population consists of eyes with a diagnosis of mild to moderate open-angle glaucoma, inadequately controlled IOP, pseudophakia and no prior incisional glaucoma surgery. In this study, open angle glaucoma includes primary open-angle glaucoma (POAG), pseudoexfoliative glaucoma (PXG), and pigmentary glaucoma (PDG). IOP is considered inadequately controlled if IOP is ≥18 mmHg with a) ≥2 classes of topical medications, b) documented intolerance to topical medications, or c) in the opinion of the investigator, subject has high risk of medication non-compliance due to physical or mental limitations.
Following washout of all hypotensive medications, a preoperative IOP and diurnal IOP will be determined. On the day of surgery, qualified study subjects will receive a single Hydrus Microstent. The primary and secondary effectiveness endpoints will be evaluated at 12 months. Safety will be evaluated throughout the study through 24-month follow-up.
Routine follow-up will be conducted at scheduled visits and ocular status will be monitored. Prior to the 12- and 24-month visits, patients on medications will repeat washout, and a diurnal IOP measurement will be taken in the same manner as preoperatively.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
22/YH/0069
Date of REC Opinion
18 May 2022
REC opinion
Further Information Favourable Opinion