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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimally invasive micro sclerostomy (MIMS) | Experimental | create a drainage channel at the sclera-corneal junction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally Invasive Micro Sclerostomy (MIMS) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular Pressure Reduction | Proportion of subjects achieved a 20% or greater reduction in IOP from Baseline on the same or less number of medications | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Intraocular Pressure | Mean change in IOP from baseline | 52 weeks |
| Adverse Event | Incidence of adverse events related to MIMS® device/procedure, throughout the study follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| S.V.Malayan'S Eye Center | Yerevan | 0048 | Armenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38494493 | Derived | Voskanyan L, Ahmed IIK, Gershoni A, Barayev E, Papoyan V, Ghazaryan A, Bar-Ilan O, Zahavi A, Glovinsky Y, Geffen N. Minimally invasive micro sclerostomy (MIMS) procedure in the treatment of open-angle glaucoma. BMC Ophthalmol. 2024 Mar 18;24(1):122. doi: 10.1186/s12886-024-03384-y. |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| 52 weeks |