Trial Outcomes & Findings for eSight Eyewear Quality of Life and Efficacy Study (NCT NCT02616900)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

74 participants

Primary outcome timeframe

Baseline and after three months of device use.

Results posted on

2019-04-05

Participant Flow

51 participants selected from the patient population at six low vision rehabilitation clinics, in the period Dec 16, 2015 through September 19, 2016.

The study had only one arm.

Participant milestones

Participant milestones
Measure	eSight Eyewear Main arm eSight Eyewear: primary intervention
Overall Study STARTED	74
Overall Study Completed 3mo Trial	57
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	23

Reasons for withdrawal

Reasons for withdrawal
Measure	eSight Eyewear Main arm eSight Eyewear: primary intervention
Overall Study Lack of Efficacy	7
Overall Study Lost to Follow-up	2
Overall Study Protocol Violation	5
Overall Study Withdrawal by Subject	3
Overall Study Incomplete data	6

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	eSight Eyewear n=51 Participants Main arm eSight Eyewear: primary intervention
Age, Categorical <=18 years	3 Participants n=51 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=51 Participants
Age, Categorical >=65 years	9 Participants n=51 Participants
Age, Continuous	48 years STANDARD_DEVIATION 17.2 • n=51 Participants
Sex: Female, Male Female	21 Participants n=51 Participants
Sex: Female, Male Male	30 Participants n=51 Participants

PRIMARY outcome

Timeframe: Baseline and 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.

Outcome measures

Outcome measures
Measure	eSight Eyewear n=51 Participants Main arm eSight Eyewear: primary intervention
Quality of Life Improvement After Three Months of Device Use	0.84 Logits Standard Deviation 1.265

SECONDARY outcome

Timeframe: Baseline and after three months of device use.

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).

Outcome measures

Outcome measures
Measure	eSight Eyewear n=51 Participants Main arm eSight Eyewear: primary intervention
Improvement in Visual Acuity	-0.76 LogMAR Standard Deviation 0.30

SECONDARY outcome

Timeframe: Baseline and after three months of device use.

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)

Outcome measures

Outcome measures
Measure	eSight Eyewear n=51 Participants Main arm eSight Eyewear: primary intervention
Improvement in Visual Contrast Performance in Log Units.	0.53 Log Units Standard Deviation 0.55

Adverse Events

eSight Eyewear

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rob Hilkes

eSight Corporation

Phone: 613 276-4145

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60