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A good efficacy as well as good rotary stability is expected with the ocular implant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SISA implant | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fitting of ocular implant | Device | Removal of natural lens and replacement with a SISA monofocal intraocular implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rotational stability of SISA monofocal implant following cataracts surgery | rotation in degrees measured by Labview software | 4 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Rotational stability of SISA monofocal implant following cataracts surgery | rotation in degrees measured by Labview software | Day 0 |
| Rotational stability of SISA monofocal implant following cataracts surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Nimes | Nîmes | 30029 | France |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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rotation in degrees measured by Labview software
| Day 7 |
| Rotational stability of SISA monofocal implant following cataracts surgery | rotation in degrees measured by Labview software | 1 Month |
| Centering of SISA monofocal implant | Distance in mm between centers of the coreal and optic ellipses | Day 0 |
| Centering of SISA monofocal implant | Distance in mm between centers of the coreal and optic ellipses | Day 7 |
| Centering of SISA monofocal implant | Distance in mm between centers of the coreal and optic ellipses | Month 1 |
| Centering of SISA monofocal implant | Distance in mm between centers of the coreal and optic ellipses | Month 4 |
| Refractive precision | Early Treatment Diabetic Retinopathy Study scale; chart 1 at 4 meters; diopters | Day 7 |
| Refractive precision | Early Treatment Diabetic Retinopathy Study scale; chart 1 at 4 meters; diopters; | Month 1 |
| Refractive precision | Early Treatment Diabetic Retinopathy Study scale; chart 1 at 4 meters; diopters | Month 4 |
| Visual acuity with and without correction | Early Treatment Diabetic Retinopathy Study scale, logMAR | Day 7 |
| Visual acuity with and without correction | Early Treatment Diabetic Retinopathy Study scale, logMAR | Month 1 |
| Visual acuity with and without correction | Early Treatment Diabetic Retinopathy Study scale, logMAR | Month 4 |
| Perioperative complications | Yes/no | Day 0 |
| Postoperative complications | Yes/no | Day 7 |
| Occurrence of undesirable events, | Presence/absence of each event, including, but not limited to: inflammation, retinal detachment, macular edema, corneal endothelial lesion,corneal edema, implant gets decentred or tilted, | Day 0 |
| Occurrence of undesirable events, | Presence/absence of each event, including, but not limited to: inflammation, retinal detachment, macular edema, corneal endothelial lesion,corneal edema, implant gets decentred or tilted, | Day 7 |
| Occurrence of undesirable events, | Presence/absence of each event, including, but not limited to: inflammation, retinal detachment, macular edema, corneal endothelial lesion,corneal edema, implant gets decentred or tilted, | Month 1 |
| Occurrence of undesirable events, | Presence/absence of each event, including, but not limited to: inflammation, retinal detachment, macular edema, corneal endothelial lesion,corneal edema, implant gets decentred or tilted, | Month 7 |