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The clinical study is closed to further enrolment based on the lack of perceived need to compare the study device with the control device.
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| Name | Class |
|---|---|
| Opera CRO, a TIGERMED Group Company | OTHER |
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Interventional, Multicentre, controlled, randomized, single blind, twoarmed non-inferiority trial
To evaluate the non-inferiority of the progressive extended depth of focus Intraocular Lens MINI WELL READY® in terms of visual performance, quality of vision and subjective outcomes versus the trifocal Intraocular Lens FineVision® after a follow up period of 2-6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MINI WELL READY ® | Experimental | BILATERAL IMPLANTATION OF MINI WELL READY®, A PROGRESSIVE EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS IN PATIENTS WITH CATARACT SURGERY |
|
| FineVision ® | Other | FINE VISION®, A TRIFOCAL INTRAOCULAR LENS IMPLANTATION IN PATIENTS WITH CATARACT SURGERY |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MINI WELL READY ® | Device | BILATERAL IMPLANTATION OF MINI WELL READY®, A PROGRESSIVE EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS IN PATIENTS WITH CATARACT SURGERY |
|
| Measure | Description | Time Frame |
|---|---|---|
| Defocus curve - binocular | Defocus curve assessment | 6 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Refraction | Ocular refraction evaluation | 6 months |
| Visual Acuity Evaluation | Uncorrected Distance Visual Acuity (UDVA) | 6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gianluca Stivale | SIFI SpA | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophtalmologie Hôpital Morvan | Brest | France | ||||
| Clinique Juge |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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| FINE VISION® | Device | FINE VISION®, A TRIFOCAL INTRAOCULAR LENS IMPLANTATION IN PATIENTS WITH CATARACT SURGERY |
|
| Visual Acuity Evaluation | Corrected Distance Visual Acuity (CDVA) Uncorrected Intermediate Visual Acuity (UIVA) | 6 months |
| Visual Acuity Evaluation | Distance Corrected Intermediate Visual Acuity (DCIVA) | 6 months |
| Visual Acuity Evaluation | Uncorrected Near Visual Acuity (UNVA) | 6 months |
| Visual Acuity Evaluation | Distance Corrected Near Visual Acuity (DCNVA) | 6 months |
| Reading speed | Reading speed performance | 6 months |
| Halometry | Halos evaluation | 6 months |
| Contrast sensitivity | Contrast sensitivity evaluation | 6 months |
| Subject satisfaction questionnaire - VF-11R | Subject satisfaction questionnaire - VF-11R "revised version": Annex A: Subject's glasses independence and light dependence Annex B: Quality of Vision (QoV) questionnaire | 6 months |
| Operative Complications / Postoperative Complications / Adverse Event Assessment | Assessment of Operative Complications, Postoperative Complications, Adverse Events | 6 months |
| Marseille |
| 13008 |
| France |