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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 24 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 24 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 |
|---|---|---|
| Serious Adverse Event | Overall incidence of serious adverse events | 12 weeks |
| Drainage Channel Creation | Ability to successfully perform a drainage channel | Index procedure day |
| Measure | Description | Time Frame |
|---|---|---|
| Serious Adverse Event | Overall incidence of serious adverse events | 24 Weeks |
| Intraocular Pressure | Intraocular Pressure between 6 mmHg and 20 mmHg |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Agarwal Eye Hospital Ltd. | Chennai | 600086 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34731867 | Derived | Geffen N, Kumar DA, Barayev E, Gershoni A, Rotenberg M, Zahavi A, Glovinsky Y, Agarwal A. Minimally Invasive Micro Sclerostomy (MIMS) Procedure: A Novel Glaucoma Filtration Procedure. J Glaucoma. 2022 Mar 1;31(3):191-200. doi: 10.1097/IJG.0000000000001955. |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| 24 Weeks |