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| Name | Class |
|---|---|
| University of Siena | OTHER |
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To compare the intraocular pressure (IOP) and number of glaucoma medications lowering of microinvasive glaucoma surgery (MIGS) with the implantation of the trabecular device Hydrus (Ivantis) as a solo procedure and 360° selective laser trabeculoplasty (SLT) to treat primary open angle glaucoma (POAG).
Eligible study patients diagnosed with POAG and not sufficiently controlled by, intolerant of, or non-compliant with their current IOP-lowering regimen. Patients with IOP>21 mm Hg upon at least two consecutive measurements. Study subjects with typical glaucomatous visual field (VF) loss on Octopus or Humphrey automated perimetry (Carl Zeiss Meditec, Dublin, CA) and glaucomatous alterations to the optic nerve head. Visual field classified as glaucomatous according to the European Glaucoma Society guidelines.
Exclusion criteria : eye surgery in the previous 6 months, any previous surgery for glaucoma, evidence of glaucoma of a type other than POAG, and medication with systemic or topical steroids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MIGS Hydrus Ivantis | Experimental | opening the anterior chamber (2mm.) injecting visco-material, injecting the Hydrus stent in the Schlemm's canal under gonioscopic control |
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| SLT | Experimental | Laser Solutis SLT laser (Quantel Medical, Clermont-Ferrand, France): this frequency-doubled, Q-switched Nd:YAG laser emits light at a wavelength of 532 nm, with a pulse duration of 4 ns, a spot size of 400 µm and pulse energy ranging from 0.2 to 2 mJ |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIGS Hydrus Ivantis | Device | implant of the micro stent in the nasal Schlemm's canal |
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| Measure | Description | Time Frame |
|---|---|---|
| change in the intraocular pressure compared to baseline | measurement with GAT in mm Hg | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| change in the number of glaucoma medications compared to baseline | accountability of IOP lowering medications used by the patient | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| change of visual acuity compared to baseline | ETDRS visual acuity scale | 6 months and 1 year post-intervention |
| change of visual field compared to baseline | MD and PSD |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Fea, MD | Clinica Oculistica | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmology Institute, University of Turin | Turin | 10138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35943114 | Derived | Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3. |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| 360 degrees SLT | Procedure | Laser Solutis SLT laser (Quantel Medical, Clermont-Ferrand, France): this frequency-doubled, Q-switched Nd:YAG laser emits light at a wavelength of 532 nm, with a pulse duration of 4 ns, a spot size of 400 µm and pulse energy ranging from 0.2 to 2 mJ |
|
| 1 year post-intervention |