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To assess the safety and effectiveness of the Juvene® IOL for the treatment of aphakia and mitigation of the effects of presbyopia after removal of the natural crystalline lens due to cataract.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational IOL | Experimental | Juvene® IOL |
|
| Control IOL | Active Comparator | Tecnis® Monofocal (ZCB00, PCB00 or DCB00) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Juvene IOL | Device | Cataract extraction and implantation of a posterior chamber IOL |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Distance-corrected intermediate ETDRS LogMar visual acuity | Monocular photopic distance-corrected intermediate visual acuity (DCIVA) at 66 cm | 12 Months |
| Distance-corrected intermediate ETDRS LogMar visual acuity vs Control | Monocular photopic distance-corrected intermediate visual acuity (DCIVA) statistical superiority over the Control group | 12 Months |
| Defocus curve testing with ETDRS chart | Monocular diopters of depth of focus (DOF) | 12 Months |
| Best corrected distance ETDRS LogMar visual acuity vs control | Monocular photopic best corrected distance visual acuity (BCDVA) statistical non-inferiority to the Control group | 12 Months |
| Best corrected distance ETDRS LogMar visual acuity | Monocular photopic best corrected distance visual acuity (BCDVA) | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Distance-corrected near ETDRS LogMar visual acuity | Monocular photopic distance-corrected near visual acuity (DCNVA) at 40 cm | 12 Months |
| Distance-corrected near ETDRS LogMar visual acuity vs control |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick R Casey, O.D. | Contact | (949) 472-5112 | info@lensgen.com |
| Name | Affiliation | Role |
|---|---|---|
| Patrick R Casey, O.D. | LensGen, Inc. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35297798 | Background | Garg S, De Jesus MT, Fletcher LM, Chayet A, Barragan E, Casey P. Twelve-month clinical outcomes after implantation of a new, modular, anterior shape-changing fluid optic intraocular lens. J Cataract Refract Surg. 2022 Oct 1;48(10):1134-1140. doi: 10.1097/j.jcrs.0000000000000935. |
| Label | URL |
|---|---|
| Company website | View source |
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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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A prospective, randomized, controlled, double-masked, phased, multicenter clinical study
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The subject will be masked to randomization assignment and will be unmasked at the completion of the study. Scheduled masked postoperative assessments will be performed by a masked examiner
| Tecnis® Monofocal (ZCB00, PCB00 or DCB00) |
| Device |
Cataract extraction and implantation of a posterior chamber IOL |
|
Monocular photopic distance-corrected near visual acuity (DCNVA) at 40 cm statistical superiority over the Control group
| 12 Months |