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The clinical investigation is a post-market clinical follow up study whereby patients undergoing routine cataract surgery will have monolateral implantation of a commercially available, CE approved monofocal intraocular lens MicroPure 1.2.3. (PhysIOL, Liège, Belgium).
The examinations consist of visual acuity data, contrast sensitivity exams, slitlamp examinations and posterior capsule opacification (PCO) grading.
Follow up will be up to 24 months postoperative.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IOL Implantation experimental | Experimental | Implantation of Micropure 1.2.3. in one of the eyes of the study subject |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IOL implantation | Device | Implantation of monofocal IOL Micropure 1.2.3 |
|
| Measure | Description | Time Frame |
|---|---|---|
| monocular Corrected Distance Visual Acuity (CDVA) under photopic conditions | The primary study end point is to show statistically equal visual acuity outcomes on monocular Corrected Distance Visual Acuity (CDVA) under photopic conditions compared to literature data on a monofocal hydrophobic IOL (Alcon - Acrysof SN60AT). | 6 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Posterior capsule opacification (PCO) grading | grade of the PCO determined by slitlamp | 2 years postoperative |
| Uncorrected Distance Visual acuity (UDVA) | Monocular Uncorrected Distance Visual acuity (UDVA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Domenico Schiano, MD | Fondazione GB Bietti - IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliera San Giovanni Addolorata - presidio Britannico | Rome | 00184 | Italy | |||
| Fondazione GB Bietti - IRCCS |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| 6 months postoperative |
| Contrast Sensitivity | Contrast Sensitivity under photopic and mesopic light conditions | 6 months postoperative |
| Glistening assessment | Assessment of glistenings by slitlamp determination | 2 years postoperative |
| Rome |
| 00198 |
| Italy |