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This study is a 3-month, prospective, up to 2 center, bilateral, randomized subject masked clinical evaluation of a monofocal intraocular lens (IOL) when both eyes are targeted for emmetropia and when the non-dominant eye is targeted for mini monovision (-0.75 D) in patients with or without astigmatism undergoing routine cataract surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emmetropia | Active Comparator | The target refraction for both eyes will be emmetropia (± 0.25 D). |
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| Mini monovision | Experimental | The target refraction for the dominant eye will be plano (± 0.25 D) and for the non-dominant eye between -0.75D ±0.15. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eyhance IOL | Device | Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target emmetropia OU. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Distance-corrected Intermediate (66 cm) Visual Acuity at 3 Months. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Low Contrast Distance Visual Acuity at 3 Months | 3 months | |
| Distance-corrected Near Visual Acuity at Best Distance at 3 Months | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kerry D Solomon | Carolina Eyecare Physicians | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Sight | Sarasota | Florida | 34239 | United States | ||
| Carolina Eyecare Physicians, LLC |
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| ID | Title | Description |
|---|---|---|
| FG000 | Emmetropia | The target refraction for both eyes will be emmetropia (± 0.25 D). Eyhance IOL: Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target emmetropia OU. Eyhance IOL: Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target mini monovision in the non-dominant eye. |
| FG001 | Mini Monovision | The target refraction for the dominant eye will be plano (± 0.25 D) and for the non-dominant eye between -0.75D ±0.15. Eyhance IOL: Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target emmetropia OU. Eyhance IOL: Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target mini monovision in the non-dominant eye. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Emmetropia | The target refraction for both eyes will be emmetropia (± 0.25 D). Eyhance IOL: Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target emmetropia OU. Eyhance IOL: Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target mini monovision in the non-dominant eye. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Binocular Distance-corrected Intermediate (66 cm) Visual Acuity at 3 Months. | Posted | Mean | Standard Deviation | logMAR | 3 months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Emmetropia | The target refraction for both eyes will be emmetropia (± 0.25 D). Eyhance IOL: Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target emmetropia OU. Eyhance IOL: Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target mini monovision in the non-dominant eye. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Central retinal vein occlusion | Eye disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Carolina Eyecare Physicians, LLC | 8438813937 | hps@cepmd.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 10, 2022 | Jan 19, 2024 | Prot_SAP_000.pdf |
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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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| Eyhance IOL | Device | Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target mini monovision in the non-dominant eye. |
|
| Mt. Pleasant |
| South Carolina |
| 29464 |
| United States |
| BG001 |
| Mini Monovision |
The target refraction for the dominant eye will be plano (± 0.25 D) and for the non-dominant eye between -0.75D ±0.15. Eyhance IOL: Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target emmetropia OU. Eyhance IOL: Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target mini monovision in the non-dominant eye. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
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| Secondary | Binocular Low Contrast Distance Visual Acuity at 3 Months | Posted | Mean | Standard Deviation | logMAR | 3 months |
|
|
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| Secondary | Distance-corrected Near Visual Acuity at Best Distance at 3 Months | Posted | Mean | Standard Deviation | logMAR | 3 months |
|
|
|
| 0 |
| 34 |
| 2 |
| 34 |
| 0 |
| 34 |
| EG001 | Mini Monovision | The target refraction for the dominant eye will be plano (± 0.25 D) and for the non-dominant eye between -0.75D ±0.15. Eyhance IOL: Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target emmetropia OU. Eyhance IOL: Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target mini monovision in the non-dominant eye. | 0 | 37 | 0 | 37 | 0 | 37 |
| Ischemic optic neuropathy | Eye disorders | Non-systematic Assessment |
|
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