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This is a single-site, unmasked, 4-visit, randomized 3x3 cross-over clinical trial to quantify intraocular light scatter in different age groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 770 +/- 9nm/ 830 +/- 15nm/ 900 +/- 15nm | Experimental | Eligible subjects will be randomized to wavelength sequence 770 +/- 9nm/ 830 +/- 15nm/ 900 +/- 15nm. Within each wavelength, subjects will be further randomized to a pupil size sequence (3mm, 4mm, 6mm). Study endpoints will be measured at 3 different pupil sizes. |
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| 770 +/- 9nm/ 900 +/- 15nm/ 830 +/- 15nm | Experimental | Eligible subjects will be randomized to wavelength sequence 770 +/- 9nm/ 900 +/- 15nm/ 830 +/- 15nm. Within each wavelength, subjects will be further randomized to a pupil size sequence (3mm, 4mm, 6mm). Study endpoints will be measured at 3 different pupil sizes. |
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| 830 +/- 15nm/ 770 +/- 9nm/ 900 +/- 15nm | Experimental | Eligible subjects will be randomized to wavelength sequence 830 +/- 15nm/ 770 +/- 9nm/ 900 +/- 15nm. Within each wavelength, subjects will be further randomized to a pupil size sequence (3mm, 4mm, 6mm). Study endpoints will be measured at 3 different pupil sizes. |
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| 830 +/- 15nm/ 900 +/- 15nm/ 770 +/- 9nm | Experimental | Eligible subjects will be randomized to wavelength sequence 830 +/- 15nm/ 900 +/- 15nm/ 770 +/- 9nm. Within each wavelength, subjects will be further randomized to a pupil size sequence (3mm, 4mm, 6mm). Study endpoints will be measured at 3 different pupil sizes. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adaptive Optics System (AO) | Device | Subjects will have their higher and lower order aberrations corrected with the AO system. |
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| Measure | Description | Time Frame |
|---|---|---|
| Point Spread Function (PSF) for 3mm | Point spread function will be collected in one eye at each Visits 2, 3 and 4 for 3mm pupil size for the assigned wavelength at that visit. The PSF is defined as the way an optical system blurs a point source of light. | up to 2-week follow-up |
| Point Spread Function (PSF) for 4 mm | Point spread function will be collected in one eye at each Visits 2, 3 and 4 for 4mm pupil size for the assigned wavelength at that visit. The PSF is defined as the way an optical system blurs a point source of light. | up to 2-week follow-up |
| Point Spread Function (PSF) for 6 mm | Point spread function will be collected in one eye at each Visits 2, 3 and 4 for 6mm pupil size for the assigned wavelength at that visit. The PSF is defined as the way an optical system blurs a point source of light. | up to 2-week follow-up |
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Inclusion Criteria:
Potential subjects must satisfy all the following criteria to be enrolled in the study:
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 |
|---|---|---|
| Johnson & Johnson Vision Care Clinical Trial | Johnson & Johnson Vision Care | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Houston College of Optometry | Houston | Texas | 77204 | United States |
Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
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| 900 +/- 15nm/ 830 +/- 15nm/ 770 +/- 9nm | Experimental | Eligible subjects will be randomized to wavelength sequence 900 +/- 15nm/ 830 +/- 15nm/ 770 +/- 9nm. Within each wavelength, subjects will be further randomized to a pupil size sequence (3mm, 4mm, 6mm). Study endpoints will be measured at 3 different pupil sizes. |
|
| 900 +/- 15nm/ 770 +/- 9nm/ 830 +/- 15nm | Experimental | Eligible subjects will be randomized to wavelength sequence 900 +/- 15nm/ 770 +/- 9nm/ 830 +/- 15nm. Within each wavelength, subjects will be further randomized to a pupil size sequence (3mm, 4mm, 6mm). Study endpoints will be measured at 3 different pupil sizes. |
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