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Minimally Invasive Micro Sclerostomy: Performance and Safety Evaluation Study

Glaucoma Clinical Trial

Official title:
Minimally Invasive Micro Sclerostomy: Performance and Safety Evaluation Study

Clinical Trial Summary

Eligible Glaucoma patients will undergo pre-surgery examination including: medicines list, blood tests and ECG. On surgery day: intraocular pressure (IOP) will be measured. Then a sub-conjunctival injection of Mitomycin C will be administered . The Minimally Invasive Micro Sclerostomy (MIMS) procedure is designed to create a drainage channel at the sclera-corneal junction by penetrating through the wall [scleral tissue] . MIMS procedure may be combined with cataract surgery. Patients will be followed up to 52 weeks post operation.

Clinical Trial Description

Eligible patients will have ECG and blood test up to 30 days prior to the MIMS procedure. Description of MIMS procedure: on surgery day, intraocular pressure (IOP) will be measured. Then a sub-conjunctival injection of Mitomycin C will be administered . creating drainage channel at the sclera-corneal junction by penetrating through the wall [scleral tissue]. MIMS procedure may be combined with cataract surgery. Post-operatively the patient will be treated with dexamethasone-neomycin drops for at least one month. Patients will be followed up to 52 weeks post operation. The following measurements will be included: - Intra Ocular Pressure (IOP) - Best Corrected Visual Acuity (BCVA) - Slit Lamp Biomicroscopic evaluation - Anterior Segment Optical coherence tomography (OCT) - Fundus Examination ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04503590
Study type Interventional
Source Sanoculis Ltd
Contact
Status Completed
Phase N/A
Start date May 29, 2019
Completion date August 11, 2022
View Details
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