Health Condition 1: H401- Open-angle glaucoma
Conditions
Interventions
Intervention1: MINI SO627: Glaucoma Drainage Device to reduce Intra Ocular Pressure
Control Intervention1: NIL: NIL
Sponsors
iSTAR Medical SA
Eligibility
Inclusion criteria
Inclusion criteria: 1.Males or females, 18 years of age or older. 2.Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier. 3.Grade 3 (open, 20�35 degrees) or grade 4 (wide open, 35�45 degrees) according to Shaffer Angle Grading System. 4. Glaucoma not adequately controlled by one to four different topical hypotensive medication(s), given each for at least one month, as confirmed by 21mmHg 5. Patients must be willing and able to return for scheduled study�related examinations. 6. Patients must provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to Shaffer Angle Grading System in the study eye. 2. Neovascular glaucoma in the study eye. 3. Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant in the stud eye. 4. Prior glaucoma surgery in the study eye. Patient treated with argon laser trabeculoplasty or selective laser trabeculoplasty in the study eye are eligible if treatment was performed � 90 days before baseline visit in the study eye. 5. Visual field defect in the 10�degree central field in the study eye. 6. Any eye surgery that was performed 7. Anticipated need for ocular surgery or retinal laser procedure in the study eye 12 months following surgery in the study eye. 8. Anterior chamber anatomic configuration of high risk for development of angle closure glaucoma in the study eye. 9. Pre�existing ocular or systemic pathology that, in the opinion of the physician, is likely to cause postoperative complications following implantation of the device in the study eye. 10. Clinically significant corneal disease (e.g., corneal dystrophy) in the study eye. 11. Evidence of crystalline lens subluxation or luxation in the study eye. 12. Evidence of vitreous loss in the anterior chamber in the study eye. 13. Clinically significant intra�ocular inflammation or infection, presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis, active proliferative/inflammatory retinopathy in the study eye. 14. Presence of silicone oil in the study eye. 15. Patients treated with systemic acetazolamide within 3 days before screening/baseline visit. 16. Patient with poor vision score: +1.0 in non�study eye, unless there is an expected benefit for the study eye in the opinion of the investigator. 17. Participation in any study involving an investigational drug or device within the past 3 months and planned participation to any other study during the present study. 18. Only for women of childbearing potential: positive blood pregnancy test at baseline visit. 19. Individuals under tutorship or trusteeship.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to show a greater than 20% reduction in medicated diurnal IOP between baseline visit and diurnal IOP 6 months after surgery with or without the use of concomitant use of IOPââ?¬?lowering medications.Timepoint: 6 months post surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To test the absolute and relative (in %) reduction in medicated or unmedicated (without washout) diurnal IOP between baseline visit and medicated diurnal IOP at 12ââ?¬? and 24 months after surgery. 2.To assess the safety of the MINIject in terms of nature and severity of AE/SAE, ADE/SADE, DDs and UADEs. Data can be pooled with other trials to compare the safety of SODT and SODT to implant MINIject glaucoma implant.Timepoint: 6, 12, 24 months post surgery | — |
Countries
Colombia, India, Panama
Contacts
Public ContactNaresh Kumar Pagidimarry
Maxivision Super Speciality Eye Hospital
Outcome results
None listed