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The primary study objective is to evaluate the safety and effectiveness of the VisAbility™ Micro Insert System for improvement in binocular distance corrected near visual acuity in presbyopic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VisAbility™ Micro Insert System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VisAbility™ Micro Insert System | Procedure | Surgeon will proceed to VisAbility™ Micro Insert System treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary effectiveness endpoint is improvement of binocular DCNVA at 12 months postoperative. | This endpoint will evaluated the improvement of postoperative binocular distance corrected near visual acuity (DCNVA) in 75% of bilaterally implanted subjects at 12 months postoperative | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary effectiveness endpoint is change in patient quality of life from baseline, as assessed by the NAVQ-P patient questionnaire. | The secondary endpoint measures the change in patient quality of life from baseline, as assessed by the NAVQ-P patient questionnaire. | 12 months postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Safia Ayachi | Contact | +3388308811 | safia@medevise-consulting.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitäts-Augenklinik Heidelberg | Recruiting | Heidelberg | Germany |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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