Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Single-center, open-label, prospective study in healthy volunteers desiring refraction for correction of visual acuity to compare a handheld device supported by a mobile application with the phoropter and autorefractor.
Single-center, open-label, prospective study in healthy volunteers desiring refraction for correction of visual acuity to compare a handheld device supported by a mobile application with the phoropter and autorefractor in male or female subjects 30 to 65 years of age.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Refraction with a Hand-held Device Supported by Mobile App. | Experimental | BCVA with handheld device with app. |
|
| Manual Refraction | Active Comparator | BCVA with phoropter |
|
| Automated Refraction | Active Comparator | BCVA with autorefractoer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hand-held device supported by a mobile application | Device | Hand-held device supported by a mobile application to obtain refractive error of the eye. |
|
| Measure | Description | Time Frame |
|---|---|---|
| BVCA Utilizing Refraction Results From Handheld Device Compared to Manual Refraction Methods for the Age Stratum 45 Through 65 Years | Best-corrected visual acuity (BVCA) utilizing refraction results using the handheld device with supporting application will be compared to standard manual refraction methods (using a phoropter) for the age stratum 45 through 65 years. | Through study completion, an average of 5 months |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Spherical correction > +8 or < -10
Using anticholinergic medications (including first-generation antihistamines) or other medications known to affect visual acuity within the greater of 3 days or 5 half-lives prior to enrolling in this study
Using an investigational drug or approved therapy for investigational use within the greater of 3 days or 5 half-lives prior to enrolling in this study
Has initiated any new medication in the past 2 weeks that, in the best medical judgment of the investigator, would impact their participation in the study or ability to use the device
Eye disease, including but not limited to:
Eye surgery within the last 12 months (including Lasik or lens replacement)
Subject does not have the physical dexterity to properly operate the device or the on the smartphone in the investigator's opinion.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| James Peace, MD | United Medical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United Medical Research Institute | Inglewood | California | 90301 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | BCVA with handheld device with app. Phoropter: Manual refraction and ETDRS chart Autorefractor: Automated refraction |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| 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 | Jun 17, 2019 |
Not provided
Not provided
All enrolled subjects will have measurements with the phoropter, autorefractor and handheld device plus mobile app.
Not provided
Not provided
Not provided
| Phoropter | Device | Manual refraction and ETDRS chart |
|
| Autorefractor | Device | Automated refraction |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Refraction With a Hand-held Device Supported by Mobile App. | BCVA with handheld device with app. Phoropter: Manual refraction and ETDRS chart Autorefractor: Automated refraction |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| 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 | BVCA Utilizing Refraction Results From Handheld Device Compared to Manual Refraction Methods for the Age Stratum 45 Through 65 Years | Best-corrected visual acuity (BVCA) utilizing refraction results using the handheld device with supporting application will be compared to standard manual refraction methods (using a phoropter) for the age stratum 45 through 65 years. | Posted | Mean | 95% Confidence Interval | logMAR | Through study completion, an average of 5 months |
|
|
|
6 months
No difference from standard definition. None observed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Refraction With a Hand-held Device Supported by Mobile App. | BCVA with handheld device with app. Phoropter: Manual refraction and ETDRS chart Autorefractor: Automated refraction | 0 | 230 | 0 | 230 | 0 | 230 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP Science and Technology | EyeQue | 5104558168 | noam.sapiens@eyeque.com |
| Sep 29, 2021 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D001251 | Astigmatism |
| D009216 | Myopia |
| D006956 | Hyperopia |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided
| >=65 years |
|
| Title | Measurements |
|---|---|
|