A Study Evaluating the Safety and Efficacy of MINIject S+ in Subjects With Open Angle Glaucoma
ConditionGlaucoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsoriSTAR Medical
About this trial
This is a prospective, multi-center, international, cohort expansion study. Part 1 will be conducted in subjects with open angle glaucoma to identify the best insertion tool for MINIject S+. In Part 1, three different investigational insertion tools will be used to place MINIject implants in this first-in man study. Each arm represents a different version of the insertion tool. Subject and independent central reader will be blinded to the insertion tool used to implant MINIject S+. Part 2 will be an expansion phase where the selected insertion tool will be assessed in a larger population of subjects with open angle glaucoma and operable cataracts undergoing combined glaucoma and cataract surgery (with IOL implantation).
Eligibility criteria
Qualifiers
Males or females, 20 years of age or older
Diagnosis of open angle glaucoma (OAG) in the study eye
Iridocorneal angle grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System in all quadrants of the study eye. (For subject's undergoing combined cataract extraction (with IOL implantation) with MINIject implantation, a grade 2 angle is acceptable prior to cataract surgery so long is the angle becomes grade 3 or greater prior to MINIject implantation).
Glaucoma not adequately controlled with at least one topical hypotensive medication(s), unless the subject has an allergy / intolerance to a medication or inability to consistently access medication. Examples include but are not limited to prostaglandins, beta blockers, carbonic anhydrase inhibitors or alpha-2-agonists
Disqualifiers
Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) iridocorneal angle according to Shaffer Angle Grading System in the study eye except for the situation described in inclusion criterion #3.
Any eye surgery that was performed < 90 days before Screening/Baseline visit in the study eye
Diagnosis of diabetes mellitus with HbA1C >7%
Known or suspected allergy or hypersensitivity to medical silicone
Trial design
Treatments tested in this trial
- MIGS
Treatment groups
60 Participants
are divided into 3 treatment groupsLocations
5Honduras
Los Robles Vision d/b/a Centro Oftalmológico Robles41101, Santa Rosa de Copán Honduras
United Kingdom
Colchester General HospitalCO45JL, Colchester United Kingdom
Diana, Princess of Wales HospitalDN33 2, Grimsby United Kingdom
Royal Liverpool University HospitalL7 3, Liverpool United Kingdom
Sponsors and collaborators
iSTAR Medical
Lead sponsor
Source ClinicalTrials.gov