Trials / Completed
CompletedNCT04484155
Minimally Invasive Micro Sclerostomy: Safety and Preliminary Performance Study
Minimally Invasive Micro Sclerostomy: First in Man (FIM) Safety and Preliminary Performance Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Sanoculis Ltd · Industry
- Sex
- All
- Age
- 18 Years – 120 Years
- Healthy volunteers
- Not accepted
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 24 weeks post operation.
Detailed 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 24 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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Minimally Invasive Micro Sclerostomy (MIMS) | The System is a surgical device, designed to create a drainage channel at the sclera-corneal junction . The drainage channel is created by a Stainless Steel surgical tool. |
Timeline
- Start date
- 2018-07-16
- Primary completion
- 2020-03-02
- Completion
- 2020-03-05
- First posted
- 2020-07-23
- Last updated
- 2022-11-30
Locations
1 site across 1 country: India
Source: ClinicalTrials.gov record NCT04484155. Inclusion in this directory is not an endorsement.