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This study evaluates the reliability, validity and safety of a self administered, subjective refraction test via a mobile medical app (GoEyes) as compared to standard of care subjective manifest refraction performed by a health care provider, in subjects who have no known ocular disease or condition other than refractive error.
GoEyes is a Mobile Medical Application, which can be downloaded to a smartphone and is being developed as a self -administered subjective refraction examination that measures the refractive error of the user's eyes in the home environment without any contact or help from health care professionals.
The Study will be conducted in 2 parts; Part 1 and Part 2.
Approximately 59 participants will be enrolled In Part 1. Part 1 participants will have a GoEyes refraction test in clinic on two separate days and will also have a standard of care refraction test performed by a health care provider and best corrected visual acuity assessments.
Approximately 349 participants will be enrolled in Part 2. Part 2 participants will self administer the GoEyes test at home on 2 separate days and will also have in clinic standard of care refraction test performed by a health care provider and best corrected visual acuity assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GoEyes | Experimental | GoEyes Self administered refraction test + Standard of care refraction test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mobile medical application to self administer a subjective refraction test | Diagnostic Test | GoEyes is a software as a medical device and mobile medical application, which is downloaded to a smartphone and is a self-administered subjective refraction test that measures the refractive error of the user's eyes in the home environment without any contact or help from health care professionals |
| Measure | Description | Time Frame |
|---|---|---|
| 90% Concordance for sphere power and cylinder power (monocular) | Baseline | |
| Descriptive statistics for concordance of cylinder axis (monocular) stratified by cylinder power | Baseline | |
| Monocular refractive outcomes | Lower confidence limit of ≥ 90% for concordance (for right and left eyes separately) | Baseline |
| Monocular visual acuity | Lower confidence limit of ≥95% (for right and left eyes combined) | Baseline |
| Proportion of out-of-range eye that are correctly excluded | Baseline | |
| Incidence of Adverse Events in Part 1 | 21 days | |
| Incidence of Adverse Events in Part 2 | 8 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Descriptive statistics for sphere power and cylinder power (monocular) | Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2) | |
| Descriptive statistics for cylinder axis (monocular) stratified by cylinder power | Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karen Howse | Contact | khowse@luna.io |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Matrix Clinical Research | Not yet recruiting | Beverly Hills | California | 90210 | United States |
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The Best Corrected Visual Acuity (BCVA) assessor will be masked to GoEyes and Standard of Care refraction results.
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|
|
| Standard of care refraction test | Diagnostic Test | Standard of care subjective manifest refraction test performed by a healthcare professional |
|
| Descriptive statistics for concordance of monocular refractive outcomes (for right and left eyes separately | Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2) |
| Descriptive statistics for monocular and binocular visual acuity (for right and left eyes combined | Baseline |
| Proportion of out of range eyes that are correctly excluded | Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2) |
| Comparison of test and re-test measurements to Standard of Care (SOC) data | Baseline and Visit 2 (day 2-21 for part 1 and day 2-8 for part 2) |
| Rate of disagreement between GoEyes screening at home and in-clinic screening | Baseline |
| North Bay Eye Associates | Not yet recruiting | Petaluma | California | 94954 | United States |
|
| Empire Clinical Research | Not yet recruiting | Pomona | California | 91767 | United States |
|
| Segal Drug Trials | Recruiting | Delray Beach | Florida | 33484 | United States |
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| Butchertown Clinical Trials | Not yet recruiting | Louisville | Kentucky | 40206 | United States |
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| Tauber Eye Center | Not yet recruiting | Kansas City | Missouri | 64111 | United States |
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| IMA Research | Not yet recruiting | Las Vegas | Nevada | 89102 | United States |
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| Core, Inc Vita Eye Clinic | Not yet recruiting | Shelby | North Carolina | 28150 | United States |
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| Athens Eye Care | Recruiting | Athens | Ohio | 45701 | United States |
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| Optimed Research | Recruiting | Marysville | Ohio | 43040 | United States |
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| Total Eye Care | Recruiting | Memphis | Tennessee | 38119 | United States |
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| Wagner Macula & Retina | Not yet recruiting | Norfolk | Virginia | 23454 | United States |
|
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D009216 | Myopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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