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| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| Université de Montréal | OTHER |
| University Health Network, Toronto | OTHER |
| Vitreous and Retina Consultants PA |
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The "eSight Quality of Life and Efficacy Study" (eQUEST) is a prospective cohort study intended to demonstrate the functional vision and Quality of Life (QoL) improvement provided by eSight Eyewear to persons with significant visual impairment resulting from various eye conditions. The multi-site study will evaluate the efficacy of the eSight device for various Activities of Daily Living (ADLs) across a broad range of subject ages and disease types.
Subjects will receive an initial benchmark assessment to determine their visual function. This includes standard clinical tests for acuity and contrast performance. Subjects will then receive a demonstration of the device. If the demonstration shows favourable results (improved functional visual performance for some rudimentary tasks such as reading), and the subject consents to the study, the subject will return to the site a week later to receive their personalized device (lens prescriptions incorporated into the unit), and more comprehensive training on its operation. They will then use the unit in their home/work/school environment over a period of three months. At the start of the study, after a period of one month, and at the end of the three month period, the subject will visit the clinical setting for administration of various specified ADL tasks, and the Veterans Affairs (VA) Low Vision (LV) Visual Function Questionnaire (VFQ) 48-question VA LV VFQ-48 survey. The intent of this repetition is to understand how ADL proficiency and VFQ-48 QoL assessment changes over time, as the subject becomes more accustomed to the device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eSight Eyewear | Experimental | Main arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eSight Eyewear | Device | primary intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Improvement After Three Months of Device Use | The study seeks to quantify, after a period of usage of the device of three months, improvement in subjects' Quality of Life using the validated tool, "Veterans Affairs (VA) Low Vision (LV) Visual Functioning Questionnaire (VFQ) - 48 Questions" (VA LV VFQ-48). Quality of Life is measured in Logits. Individual scores ranged from -5 to +10 (a higher number is a better score). Overall improvement was 0.84 Logits. | Baseline and after three months of device use. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Visual Acuity | The study seeks to quantify, after a period of usage of the device of three months, improvement in visual acuity using standard optometric charts (e.g. "20/400 to 20/160", etc.). We measured LogMAR acuity on a standard ETDRS chart. Results show an average greater than seven-line improvement (-0.76 LogMAR). | Baseline and after three months of device use. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vitreous and Retina Consultants PA | Lakeland | Florida | 33805 | United States | ||
| Lighthouse For the Blind of the Palm Beaches |
The study had only one arm.
51 participants selected from the patient population at six low vision rehabilitation clinics, in the period Dec 16, 2015 through September 19, 2016.
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| ID | Title | Description |
|---|---|---|
| FG000 | eSight Eyewear | Main arm eSight Eyewear: primary intervention |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | eSight Eyewear | Main arm eSight Eyewear: primary intervention |
| 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 |
| 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 | Quality of Life Improvement After Three Months of Device Use | The study seeks to quantify, after a period of usage of the device of three months, improvement in subjects' Quality of Life using the validated tool, "Veterans Affairs (VA) Low Vision (LV) Visual Functioning Questionnaire (VFQ) - 48 Questions" (VA LV VFQ-48). Quality of Life is measured in Logits. Individual scores ranged from -5 to +10 (a higher number is a better score). Overall improvement was 0.84 Logits. | Posted | Mean | Standard Deviation | Logits | Baseline and after three months of device use. |
|
|
54 weeks. January 20, 2016 - February 6, 2017
All-Cause Mortality, Serious, or Other (non-serious) Adverse Events were monitored/assessed, but none observed. We define an adverse event as any event whereby patient health or safety is adversely affected in any manner by the study device.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | eSight Eyewear | Main arm eSight Eyewear: primary intervention | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rob Hilkes | eSight Corporation | 613 276-4145 | rhilkes@eSightcorp.com |
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| 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 | Jan 21, 2016 | Feb 6, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015354 | Vision, Low |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| UNKNOWN |
| University of Michigan | OTHER |
| Bascom Palmer Eye Institute | OTHER |
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| Improvement in Visual Contrast Performance in Log Units. | The study seeks to quantify, after a period of usage of the device of three months, improvement in contrast performance using a standard optometric "Mars Contrast Chart". Outcome is measured in Log Units ranging from 0.04 to 1.92 in decrements of 0.04 log units, a higher score indicating better contrast performance. The scale of the Mars Contrast Chart is interpreted as follows: 0.0 - 0.5 Log Units: Profound Loss 0.5 - 1.0 Log Units: Severe Loss 1.0 - 1.5 Log Units: Moderate Loss 1.5 - 1.75 Log Units: Normal Vision (>60yrs) >1.75 Log Units: Normal Vision (<60yrs) | Baseline and after three months of device use. |
| West Palm Beach |
| Florida |
| 33407 |
| United States |
| Johns Hopkins University School of Medicine, Wilmer Eye Institute | Baltimore | Maryland | 21903 | United States |
| University of Michigan Kellogg Eye Center | Ann Arbor | Michigan | 48105 | United States |
| Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |
| Université de Montréal, School of Optometry | Montreal | Quebec | H3T 1P1 | Canada |
| Withdrawal by Subject |
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| Incomplete data |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| 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 |
|
| Participants |
|
|
| Secondary | Improvement in Visual Acuity | The study seeks to quantify, after a period of usage of the device of three months, improvement in visual acuity using standard optometric charts (e.g. "20/400 to 20/160", etc.). We measured LogMAR acuity on a standard ETDRS chart. Results show an average greater than seven-line improvement (-0.76 LogMAR). | Posted | Mean | Standard Deviation | LogMAR | Baseline and after three months of device use. |
|
|
|
| Secondary | Improvement in Visual Contrast Performance in Log Units. | The study seeks to quantify, after a period of usage of the device of three months, improvement in contrast performance using a standard optometric "Mars Contrast Chart". Outcome is measured in Log Units ranging from 0.04 to 1.92 in decrements of 0.04 log units, a higher score indicating better contrast performance. The scale of the Mars Contrast Chart is interpreted as follows: 0.0 - 0.5 Log Units: Profound Loss 0.5 - 1.0 Log Units: Severe Loss 1.0 - 1.5 Log Units: Moderate Loss 1.5 - 1.75 Log Units: Normal Vision (>60yrs) >1.75 Log Units: Normal Vision (<60yrs) | Posted | Mean | Standard Deviation | Log Units | Baseline and after three months of device use. |
|
|
|
| 74 |
| 0 |
| 74 |
| 0 |
| 74 |
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| D005128 |
| Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |