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This is a bilateral, non-dispensing, randomized, controlled, double-masked, 7x7 cross-over study. Each subject will be bilaterally fitted with one of the 7 test articles in each of the 7 periods for a total of four visits. Up to two lens types will be fit at each of the four study visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test 1\Test 2\Control 2\Test 3\Control 1\Test 4\Test 5 | Experimental | Subjects between ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. |
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| Test 2\Test 3\Test 1\Test 4\Control 2\Test 5\Control 1 | Experimental | Subjects between ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. |
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| Test 3\Test 4\Test 2\Test 5\Test 1\Control 1\Control 2 | Experimental | Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. |
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| Test 4\Test 5\Test 3\Control 1\Test 2\Control 2\Test 1 | Experimental | Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test Lens 1 | Device | EMO-114 |
|
| Measure | Description | Time Frame |
|---|---|---|
| On-Axis Accommodative Response Method 1 | On-axis accommodative response with target vergence of 0.25D, 1D, 2D, 3D and 4D measured with a wavefront aberrometer. | 10 minutes post-lens insertion |
| On-Axis Accommodative Response Method 2 | On-axis accommodative response with target vergence of 0.25D, 1D, 2D, 3D and 4D measured with an open-field auto refractor. | 10 minutes post lens insertion |
| Measure | Description | Time Frame |
|---|---|---|
| Off-Axis Wavefront Aberrations with Accomodation | Off-axis wavefront aberrations at ±10°, ±20°, ±30° retinal eccentricities with targets at 4 meters will be measured. | 10 minutes post-lens insertion |
| Off-Axis Wavefront Aberrations without Accomodation |
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Inclusion Criteria:
Potential subjects must satisfy all following criteria to be enrolled in the study:
Pediatric subjects (<18 years old) must read (or be read to), understand, and sign the Statement of Information and Assent and receive a fully executed copy of the form.
Adult subjects (≥18 years old) and parent(s) or legal guardian(s) of pediatric subjects must read, understand and sign the Statement of Informed Consent and receive a fully executed copy of the form.
Appear able and willing to adhere to the instructions set forth in this clinical protocol.
Between 7 and 25 years of age (inclusive).
Have normal eyes (i.e., no ocular medications or infections of any type).
Vertex-corrected distance subjective best-sphere refraction must be between -0.75D and -5.00D (inclusive) in each eye.
Cylindrical refraction must be 1.00D or less in each eye, by subjective sphero-cylindrical refraction.
Have sphero-cylindrical best-corrected visual acuity of 20/25 or better in each eye.
Exclusion Criteria:
Potential subjects who meet any of the following criteria will be excluded from participating in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Xu Cheng | Johnson & Johnson Vision Care, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University, School of Optometry | Bloomington | Indiana | 47405 | United States |
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|
| Test 5\Control 1\Test 4\Control 2\Test 3\Test 1\Test 2 | Experimental | Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. |
|
| Control 1\Control 2\Test 5\Test 1\Test 4\Test 2\Test 3 | Experimental | Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. |
|
| Control 2\Test 1\Control 1\Test 2\Test 5\Test 3\Test 4 | Experimental | Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. |
|
| Test 5\Test 4\Control 1\Test 3\Control 2\Test 2\Test 1 | Experimental | Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. |
|
| Control 1\Test 5\Control 2\Test 4\Test 1\Test 3\Test 2 | Experimental | Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. |
|
| Control 2\Control 1\Test 1\Test 5\Test 2\Test 4\Test 3 | Experimental | Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. |
|
| Test 1\Control 2\Test 2\Control 1\Test 3\Test 5\Test 4 | Experimental | Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. |
|
| Test 2\Test 1\Test 3\Control 2\Test 4\Control 1\Test 5 | Experimental | Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. |
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| Test 3\Test 2\Test 4\Test 1\Test 5\Control 2\Control 1 | Experimental | Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. |
|
| Test 4\Test 3\Test 5\Test 2\Control 1\Test 1\Control 2 | Experimental | Subjects between the ages of 7 and 25 years will be randomly assigned to one of fourteen unique sequences of the seven lens types. |
|
| Test Lens 2 | Device | EMO-116 |
|
| Test Lens 3 | Device | EMO-118 |
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| Test Lens 4 | Device | RMY-100 |
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| Test Lens 5 | Device | Biofinity multifocal D Lens |
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| Control Lens 1 | Device | EMO-117 |
|
| Control Lens 2 | Device | Proclear 1 day |
|
Off-axis wavefront aberrations at ±30° retinal eccentricities with targets at 25 cm will be measured. |
| 10 minutes post lens insertion |