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| Name | Class |
|---|---|
| Abbott Medical Optics | INDUSTRY |
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The objective of this study is to evaluate the uncorrected binocular distance, intermediate, and near visual acuities, and assess patient's spectacle independence and satisfaction in individuals undergoing bilateral cataract extraction that have received two different arms of near add design IOLs of the same diffractive multifocal model.
This will be a multi-center, parallel comparison clinical study design with two treatment groups. One hundred (100) qualified study patients will receive a +2.75D (ZKB00) Tecnis Multifocal 1-Piece IOL in their dominant eye. Of these study patients, 50 patients will receive the +3.25D (ZLB00) Tecnis Multifocal 1-Piece IOL in their non-dominant eye and the other 50 patients will receive the +4.00D (ZMB00) Tecnis Multifocal 1-Piece IOL in their non-dominant eye. each study patient will undergo the same routine cataract extraction procedures for each eye, with the second eye scheduled to undergo cataract extraction within 7 to 30 days after the first eye. In addition, as is customary for the surgeon, each study patient will receive the same open-label pre-operative, operative and post-operative medications over the course of the study period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Group 1 | Active Comparator | 50 qualified study patients will receive the +2.75D (ZKB00) in their dominant eye and the +3.25D (ZLB00) in their non-dominant eye. |
|
| Treatment Group 2 | Active Comparator | 50 qualified study patients will receive the +2.75D (ZKB00) in their dominant eye and the +4.00D (ZMB00) in their non-dominant eye. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tecnis Multifocal 1-Piece IOL | Device | +2.75D (ZKB00), +3.25D (ZKB00), +4.00D (ZMB00) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measurements of uncorrected and best corrected visual acuities under mesopic illumination at distance, intermediate, and near using the ETDRS chart. | Uncorrected visual acuity measured under mesopic illumination using the ETDRS chart at 4 meters, 66.7cm, and 40.0 cm. Best-corrected visual acuity measured under mesopic illumination using the ETDRS chart at 4 meters, 66.7 cm, and 40.0 cm. | 90 days post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melissa Ciccarelli | Contact | 512-347-0255 | mciccarelli@dellvision.com |
| Name | Affiliation | Role |
|---|---|---|
| Steven J Dell, MD | Dell Laser Consultants | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dell Laser Consultants | Recruiting | Austin | Texas | 78746 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33061276 | Derived | Dell SJ. Evaluation of Visual and Subjective Outcomes with Mix-and-Match of Three One-Piece Tecnis Multifocal IOLs of Varying Add Powers. Clin Ophthalmol. 2020 Sep 29;14:2903-2911. doi: 10.2147/OPTH.S266120. eCollection 2020. |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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