Minimally Invasive Micro Sclerostomy: Performance and Safety Evaluation Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Glaucoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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-cornea...
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
Tracking Information
- NCT #
- NCT04503590
- Collaborators
- Not Provided
- Investigators
- Not Provided
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