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Prospective, comparative, randomized, non-masked clinical study to compare the a digital refraction with LogMAR VA testing utilizing trial lenses, to standard manual refraction using a Phoropter, and LogMAR VA testing, in accuracy of visual acuity measurement.
A digital refraction tool is a device meant to measure visual acuity and to subjectively measure refractive value for a patient's eye for the conditions of myopia and astigmatism. It is intended for adults aged 22 to 55 years that have no prior correction with up to 3.00 diopters (D) of myopia and up to 2.00 D of astigmatism, or those with prior correction up to 10.00 D of myopia and require an over-refraction of no more than 2.75 D.
LogMAR (ETDRS) chart to measure visual acuity.
The manual manifest refraction is performed by an eyecare specialist using a phoropter.
The LogMAR Visual Acuity chart is used to measure visual acuity. The manual refraction will be used in this study for obtaining the refractive error of each eye.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital refraction | Experimental | Web-based application for obtaining the refractive error and visual acuity of each eye, using a computer and a smart phone |
|
| Manual Refraction | Active Comparator | Manual manifest refraction is performed by an eyesore specialist using a phoropter. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital refraction | Device | A web-based application for obtaining the refractive error and visual acuity of each eye, using a computer and a smart phone. |
|
| Measure | Description | Time Frame |
|---|---|---|
| A digital refraction will be compared to standard manual refraction methods (using a phoropter) to the correlation of the two methods. | The difference between testing methods (Manual Refraction with a phoropter versus a digital refraction test) will be analyzed by mean, standard deviation, and 95% confidence interval overall and by the levels of refractive correction (sphere, cylinder, MRSE) and for visual acuity using LogMAR format. | After the Day 1 Visits |
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Inclusion Criteria:
Subject must be between 22 and 55 years of age at the time of consent.
Subject must have a refractive error
5. Subjects with Best Corrected Visual Acuity (BCVA) of 20/32 or better.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| S Lee | Sponsor GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site 03 | Fort Lauderdale | Florida | 33324 | United States | ||
| Site 02 |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Manual Refraction | Other | Manual refraction and ETDRS chart |
|
| Nashville |
| Tennessee |
| 37215 |
| United States |
| Site 01 | Harlingen | Texas | 78550 | United States |