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| Name | Class |
|---|---|
| Sengi | INDUSTRY |
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This investigator-initiated trial is a prospective, randomized, parallel-group, bilateral implantation study comparing Clareon TruPlus versus Clareon monofocal intraocular lenses (IOLs). Spherical and toric models are permitted in both arms based on standardized preoperative planning and clinical indication. Subjects and postoperative examiners/technicians will be masked to IOL assignment; surgeons will not be masked. The overall structure is modeled after randomized bilateral implantation cataract study designs with a Month 3 primary endpoint visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clareon TruPlus | Experimental |
| |
| Clareon monofocal | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clareon TruPlus | Device | Bilateral implantation with Clareon TruPlus |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular photopic corrected distance visual acuity (CDVA) at 4 m | 3 months postoperatively |
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| Measure | Description | Time Frame |
|---|---|---|
| Binocular photopic distance corrected intermediate visual acuity (DCIVA) at 66 cm | 3 months postoperatively | |
| Binocular photopic distance corrected near visual acuity (DCNVA) at 40 cm | 3 months postoperatively |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tetiana Huff | Contact | 713-620-7640 | tetiana.huff@berkeleyeye.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Berkeley Eye Center - Sugar Land | Recruiting | Sugar Land | Texas | 77478 | United States |
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| Clareon monofocal |
| Device |
Bilateral implantation with Clareon monofocal |
|
| Binocular mesopic corrected distance visual acuity (CDVA) at 4 m | 3 months postoperatively |
| Binocular photopic uncorrected distance visual acuity (UDVA) at 4 m | 3 months postoperatively |
| Binocular photopic uncorrected intermediate visual acuity (UIVA) at 66 cm | 3 months postoperatively |
| Binocular photopic uncorrected near visual acuity (UNVA) at 40 cm | 3 months postoperatively |
| Monocular mesopic corrected distance visual acuity (CDVA) at 4 m | 3 months postoperatively |
| Monocular mesopic distance corrected intermediate visual acuity (DCIVA) at 66 cm | 3 months postoperatively |
| Binocular mesopic best corrected distance contrast sensitivity without glare | 3 months postoperatively |
| Binocular mesopic best corrected distance contrast sensitivity with glare | 3 months postoperatively |
| Photopic low-contrast (25%) BCDVA at 4 m without glare | 3 months postoperatively |
| Binocular photopic distance-corrected defocus curve | 3 months postoperatively |
| Monocular distance-corrected defocus curve (dominant eye) | 3 months postoperatively |
| Visual disturbances questionnaire | Questionnaire for Visual Disturbances (QUVID). Lower scores indicate less frequent, severe, or bothersome visual disturbances. | 3 months postoperatively |
| Satisfaction questionnaire | The Intraocular Lens Satisfaction questionnaire (IOLSAT). Lower scores indicate higher spectacle independence and satisfaction. | 3 months postoperatively |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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