Health Condition 1: H401- Open-angle glaucoma
Conditions
Interventions
Intervention1: Minimally Invasive Micro Sclerostomy: The Minimally Invasive Micro Sclerostomy (MIMS�®) System is intended for the reduction of elevated Intraocular Pressure (IOP).
Control Interventi
Sponsors
Appasamy Ocular Devices Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Male or female � 18 years Primary open-angle Glaucoma, pseudoexfoliation Glaucoma or pigmentary Glaucoma in the study eye (EGS criteria) Optic nerve appearance characteristic of Glaucoma in the study eye Patient is treated with 0 to 5 hypotensive medications in the study eye Unsatisfactory IOP ( >21 mmHg) at the screening visit in the study eye If cataract is not present - Shaffer grade � III in all four angle quadrants in the study eye Subject is able and willing to attend all scheduled follow-up exams Subject understands and signs the informed consent
Exclusion criteria
Exclusion criteria: Ocular conditions with a poorer prognosis in the fellow eye than in the study eye Closed angle forms of Glaucoma in either eye unless scheduled for cataract surgery immediately prior to the MIMSÃ?® procedure or the study eye is pseudophakic with PCIOL. Congenital or developmental Glaucoma in either eye Other secondary Glaucoma (such as neovascular, uveitic, lens- induced, trauma-induced, or Glaucoma associated with increased episcleral venous pressure) in the study eye Peripheral anterior synechiae (PAS), rubeosis or other angle abnormalities in the study eye Subject has history of penetrating keratoplasty (PKP) Any previous surgery in the study eye (except for clear corneal cataract surgery) where the conjunctiva is not intact and elastic. Any ocular disease or history in study eye such as severe dry eye, active proliferative retinopathy, ICE syndrome, epithelial or fibrous down growth, and ocular pathology that may interfere with accurate IOP measurements Prior surgery for an ab-interno or ab-externo device implanted in or through the Schlemmââ?¬•s canal in the study eye. Best-corrected visual acuity worse than 20/40 (Snellen equivalent) in the fellow eye History of idiopathic or autoimmune uveitis in either eye Severe trauma in study eye active iris neovascularization, previous cyclodestructive procedure, prior scleral buckling procedure, presence of silicone oil, need for Glaucoma surgery combined with other ocular procedures or anticipated need for additional ocular surgery in study eye within 12 month period Vitreous present in anterior chamber, prior vitrectomy or vitreous hemorrhage in study eye Aphakia Prior vitreoretinal surgery in study eye Clinically significant ocular inflammation or infection within 90 days prior to screening Unable to discontinue use of blood thinners in accordance with surgeonââ?¬•s standard preoperative instructions Uncontrolled systemic disease that in the opinion of the investigator would put the subjectââ?¬•s health at risk and/or prevent the subject from completing all study visits Current participation or participation in another investigational drug or device clinical trial within the last 30 days before screening visit Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IOP Measurement Glaucoma Medications Best Corrected Visual Acuity Cataract grading (LOCS III) Refraction Biometry Slit lamp biomicroscopy Gonioscopy Anterior segment OCT Macular OCT Specular Microscopy Fundus Examination Optic Disc Assessments Seidel Testing Bleb Morphologic Feature Glaucoma Quality of Life Assessment Complications/ Adverse Events Timepoint: Day 1, Day 7 Ã?± 2 day, Day 14Ã?± 3 days, Week 4 Ã?± 7 days, Week 12 Ã?± 14 days, Week 24 Ã?± 14 days. | — |
Secondary
| Measure | Time frame |
|---|---|
| IOP Measurement Glaucoma Medications Best Corrected Visual Acuity Cataract grading (LOCS III) Refraction Biometry Slit lamp biomicroscopy Gonioscopy Anterior segment OCT Macular OCT Specular Microscopy Fundus Examination Optic Disc Assessments Seidel Testing Bleb Morphologic Feature Glaucoma Quality of Life Assessment Complications/ Adverse Events Timepoint: Day 1, Day 7 Ã?± 2 day, Day 14Ã?± 3 days, Week 4 Ã?± 7 days, Week 12 Ã?± 14 days, Week 24 Ã?± 14 days. | — |
Countries
India
Contacts
Public ContactDR CHITRA
Regional Institute of Ophthalmology and Government Ophthalmic Hospital
Outcome results
None listed