Glaucoma
Conditions
Keywords
MINIject
Brief summary
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).
Interventions
DEVICEMIGS
Implant MINIject S+ in supraciliary space
Sponsors
iSTAR Medical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
FG300X The distal extremity features a closed, blunt tip that opens via a hinge positioned on the upper side. The flexibility in the plane "a" is measured by the maximum force required to bend the sheath downward = 0.20 N +/- 0.06 N. The curvature slope is defined as 1-20%. FG300Y The distal extremity features a closed, blunt tip that opens via a hinge positioned on the bottom side. The flexibility in the plane "a" is measured by the maximum force required to bend the sheath downward = 0.25 N +/- 0.06 N. The curvature slope is defined as 1-20%. FG300Z The distal extremity features an open, blunt tip without hinge. The flexibility in the plane "a" is measured by the maximum force required to bend the sheath downward = 0.20 N +/- 0.06 N. The curvature slope is defined as 1-20%.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males or females, 20 years of age or older 2. Diagnosis of open angle glaucoma (OAG) in the study eye 3. 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). 4. 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 5. Minimal visual acuity in the study eye must be 35 letters EDTRS (20/200) or better and 50 letters ETDRS (20/100) or better in the fellow eye 6. Maximal C/D ratio must be 0.9 in the study eye 7. Subjects must be willing and able to follow study instructions and to return for scheduled study-related examinations 8. Subjects must provide written informed consent prior to any study procedures 9. Part 2 Only: Operable age-related cataract eligible for phacoemulsification surgery with Intraocular Lens (IOL) implantation 10. Part 2 Only: The following intraoperative criteria following the IOL implantation need to be met in order for investigator to proceed with the investigational device placement: 1. Capsulorhexis is intact and centered 2. Posterior capsular bag is intact 3. The IOL is well-centered in the capsular bag 4. There is no evidence of zonular dehiscence/rupture 5. The Anterior Chamber (AC) angle was able to be clearly visualized using direct gonioscopy.
Exclusion criteria
Subjects are not eligible for inclusion in this clinical investigation if one or more of the following criteria are met: 1. 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. 2. Any eye surgery that was performed \< 90 days before Screening/Baseline visit in the study eye 3. Diagnosis of diabetes mellitus with HbA1C \>7% 4. Known or suspected allergy or hypersensitivity to medical silicone 5. Allergy to fluorescein 6. Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant 7. Central endothelial cell density (ECD) at Screening visit with a mean value \<1900 cells/mm2 or coefficient of variation (CV) of endothelium \>0.45 A variance of 5% less than this cell count is permitted if in the clinical judgement of the Investigator the potential benefit/risk to subject participation is favorable and the central corneal endothelial morphology is characterized as normal by the usual criteria of hexagonality, polymorphism, and polymegathism 8. Anticipated need for ocular surgery or retinal laser procedure in the study eye 9. Anterior chamber anatomic configuration of high risk for development of angle closure glaucoma in the study eye, 10. Pre-existing ocular or systemic pathology that, in the opinion of the investigator (reason to be specified on the case report form), is likely to cause post-operative complications following implantation 11. Central corneal thickness greater than 600 microns 12. Clinically significant degenerative visual disorders that, in the opinion of the investigator, can impact study examinations (e.g. exudative macular degeneration or other retinal disorders) 13. Clinically significant corneal disease (e.g., corneal dystrophy) in the study eye 14. Evidence of crystalline lens subluxation or luxation in the study eye 15. Inability to perform Visual Field (VF) testing in either eye 16. Evidence of vitreous loss in the anterior chamber in the study eye 17. Clinically significant intra-ocular inflammation or infection 18. Presence of silicone oil in the study eye 19. Participation in any study involving a drug or device within the past 3 months and planned participation to any other study during the present study. There is no exclusion period after completion of the present trial 20. Only for women of childbearing potential: positive pregnancy test at Screening/Baseline visit. Pregnant or lactating women 21. Subject is under tutorship or trusteeship 22. Subject has a condition such that his / her ability to provide personal informed consent is compromised 23. Diagnosis of cataract in the study eye that is not age-related e.g., traumatic, inflammatory or resulting from diabetes in the study eye 24. Unable to discontinue anticoagulant/antiplatelet therapy (i.e. acetylsalicylic acid, coumadin, heparin, apixaban, etc.) for the surgical procedure. The amount of washout and when to restart therapy after surgery is at the Principal Investigator's discretion and may be based on literature references (see Annexes) or in consultation with the subject's primary care team.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with correct placement of the device in the supraciliary space, as assessed by the blinded central reader | 1 week | Correct placement at 1 Week will be assessed by SS-AOCT/UBM images, analyzed by an independent central reader. |
| Ease of use evaluation | during the surgery procedure | Ease of Use, as measured by sponsor review of the surgical procedure and surgeon feedback. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Best Corrected Visual Acuity from baseline to 6-, 12- and 24-months follow-up | Baseline, 6, 12, and 24 months | Best corrected visual acuity measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Change from baseline to 6-, 12- and 24-months follow-up will be evaluated. |
| Rate of secondary surgical interventions at Month 6, Month 12 and Month 24 | 6, 12, and 24 months | Cumulative rate of secondary surgical interventions due to the glaucoma device or related to glaucoma surgical procedure at Month 6, Month 12 and Month 24. |
| Change in Endothelial Cell Density from baseline to 6-, 12- and 24-months follow-up | Baseline, 6, 12 and 24 months | Change from baseline in endothelial cell density (ECD), measured at Month 6, Month 12, and Month 24. |
| Cumulative Rate of Adverse Events at 6, 12 and 24 months. | 6, 12 and 24 months | Cumulative rate of adverse events (AEs), adverse device effects (ADEs), and adverse events of special interest (AESIs) at 6-, 12- and 24-months follow-up. |
| Proportion of eyes achieving ≥20% reduction in diurnal IOP from baseline to 6-, 12- and 24-months follow-up | Baseline, 6, 12, 24 months | Proportion of study eyes achieving ≥ 20% reduction in diurnal IOP from baseline to 6 months follow-up, and from baseline to 12- and 24-months follow-up, with or without IOP lowering medications. |
| 'Qualified success' rate from baseline to 6-, 12- and 24-months follow-up | 6, 12 and 24 months | 'Qualified success' rate at 6-, 12- and 24-month follow-up. 'Qualified success' is defined as a diurnal IOP ≤ 21mmHg and \> 5mmHg with a minimum 20% diurnal IOP reduction from baseline at a given follow-up visit. |
| 'Complete success' rate from baseline to 6-, 12- and 24-months follow-up | 6, 12 and 24 months | 'Complete success' rate at 6-, 12- and 24-months follow-up. 'Complete success' is defined as diurnal IOP ≤ 21mmHg and \> 5mmHg with a minimum 20% diurnal IOP reduction from baseline without the need for any IOP-lowering medication at the given follow-up visit. |
| Change in diurnal IOP from baseline to 6-, 12- and 24-months follow-up | Baseline, 6, 12 and 24 months | Change (absolute and relative) in diurnal IOP from baseline visit to 6-, 12- and 24-months follow-up. |
| Change in number of IOP-lowering medication from baseline to 6-, 12- and 24-months follow-up. | Baseline, 6, 12 and 24-months | Change (absolute and relative) in number of IOP-lowering medications from baseline to 6-, 12- and 24-months follow-up. |
Countries
Honduras, United Kingdom
Contacts
CONTACTDelphine Hanot Mambres, PhD
CONTACTSabine Glibert
Outcome results
None listed