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The main objective is to evaluate the effectiveness of MIMS in patients with an indication for glaucoma surgery, compared to traditional surgery. The secondary objective is to assess safety. The investigating ophthalmologist will follow the patients and collect clinical data in order to identify the benefits and complications of MIMS. Patients are expected to experience fewer complications compared to traditional glaucoma surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Minimally invasive microsclerostomy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally invasive microsclerostomy | Procedure | MIMS is a filtering glaucoma surgery, which consists of creating a sclero-corneal drainage channel, to allow the flow of aqueous humor and therefore the reduction of intraocular pressure. This surgery is extremely quick, lasting 3 to 5 minutes, according to recent MIMS studies, in contrast to the duration of a trabeculectomy, the classic glaucoma surgery, which varies between 20 and 60 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of intraocular pressure by tonometry | Measure in millimeters of mercury (mmHg) | day 0, day 7, day 14, day 30, month 6, month 9 and month 12 after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| visual quality of life VFQ-25, | 25 questions about visual quality of life with Likert scale (1-5 and 1-6) | month 1, month 3, month 12 after surgery |
| Optical Coherence Tomography | high-resolution images of the retina and anterior segment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana Miguel, MD | Hôpital Privé de la Baie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Privé de la Baie | Avranches | 50300 | France | |||
| Clinique Thiers |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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|
| month 3, month 12 |
| Visual field test | Measure of visual field in degree (°) | month 3, month 12 |
| Bordeaux |
| 33100 |
| France |
| Fondation Rothschild | Paris | 75019 | France |