Trial Outcomes & Findings for The EASE Study - Human Factor and Usability Testing of a Binocular OCT System (NCT NCT02822612)

Last Updated: 2020-03-26

Results Overview

Total time for each participant to complete the binocular optical coherence tomography (OCT) examination was calculated.

Recruitment status

COMPLETED

Target enrollment

60 participants

Primary outcome timeframe

6 months

Results posted on

2020-03-26

Participant Flow

Participant milestones

Participant milestones
Measure	Retinal Disease Fourteen participants had bilateral retinal disease only (including 8 with age-related macular degeneration \[AMD\], 4 with diabetic macular edema, 1 with central serous retinopathy, and 1 with retinal vein occlusion with cystoid macular edema).	Glaucoma Thirteen participants had glaucoma only (12 with primary open angle glaucoma \[POAG\], 1 with glaucoma secondary to hypertensive uveitis).	Strabismus Fourteen participants had strabismus only (7 with esotropia, 6 with exotropia, and 1 with hypertropia).	Ocular Comorbidities Four participants had ocular comorbidities: two with bilateral POAG and AMD; one had unilateral POAG and a symptomatic epiretinal membrane in the fellow eye; and one had bilateral POAG and congenital convergent strabismus.	Healthy Volunteers Fifteen healthy volunteers with no self-reported history of ocular disease.
Overall Study STARTED	14	13	14	4	15
Overall Study COMPLETED	14	13	14	4	15
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Retinal Disease n=14 Participants Fourteen participants had bilateral retinal disease only (including 8 with age-related macular degeneration \[AMD\], 4 with diabetic macular edema, 1 with central serous retinopathy, and 1 with retinal vein occlusion with cystoid macular edema).	Glaucoma n=13 Participants Thirteen participants had glaucoma only (12 with primary open angle glaucoma \[POAG\], 1 with glaucoma secondary to hypertensive uveitis).	Strabismus n=14 Participants Fourteen participants had strabismus only (7 with esotropia, 6 with exotropia, and 1 with hypertropia).	Ocular Comorbidities n=4 Participants Four participants had ocular comorbidities: two with bilateral POAG and AMD; one had unilateral POAG and a symptomatic epiretinal membrane in the fellow eye; and one had bilateral POAG and congenital convergent strabismus.	Healthy Volunteers n=15 Participants Fifteen healthy volunteers with no self-reported history of ocular disease.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=14 Participants	0 Participants n=13 Participants	0 Participants n=14 Participants	0 Participants n=4 Participants	0 Participants n=15 Participants	0 Participants n=60 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=14 Participants	5 Participants n=13 Participants	10 Participants n=14 Participants	1 Participants n=4 Participants	12 Participants n=15 Participants	32 Participants n=60 Participants
Age, Categorical >=65 years	10 Participants n=14 Participants	8 Participants n=13 Participants	4 Participants n=14 Participants	3 Participants n=4 Participants	3 Participants n=15 Participants	28 Participants n=60 Participants
Age, Continuous	71.0 years STANDARD_DEVIATION 11.4 • n=14 Participants	64.1 years STANDARD_DEVIATION 14.7 • n=13 Participants	50.8 years STANDARD_DEVIATION 19.1 • n=14 Participants	70.5 years STANDARD_DEVIATION 8.0 • n=4 Participants	53.1 years STANDARD_DEVIATION 11.2 • n=15 Participants	60.3 years STANDARD_DEVIATION 16.1 • n=60 Participants
Sex: Female, Male Female	6 Participants n=14 Participants	7 Participants n=13 Participants	7 Participants n=14 Participants	2 Participants n=4 Participants	9 Participants n=15 Participants	31 Participants n=60 Participants
Sex: Female, Male Male	8 Participants n=14 Participants	6 Participants n=13 Participants	7 Participants n=14 Participants	2 Participants n=4 Participants	6 Participants n=15 Participants	29 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	14 participants n=14 Participants	13 participants n=13 Participants	14 participants n=14 Participants	4 participants n=4 Participants	15 participants n=15 Participants	60 participants n=60 Participants
Visual acuity (better eye)	0.35 logMAR STANDARD_DEVIATION 0.24 • n=14 Participants	0.10 logMAR STANDARD_DEVIATION 0.12 • n=13 Participants	-0.04 logMAR STANDARD_DEVIATION 0.08 • n=14 Participants	0.24 logMAR STANDARD_DEVIATION 0.42 • n=4 Participants	0.01 logMAR STANDARD_DEVIATION 0.14 • n=15 Participants	0.18 logMAR STANDARD_DEVIATION 0.25 • n=60 Participants
Visual acuity (worse eye)	0.68 logMAR STANDARD_DEVIATION 0.34 • n=14 Participants	0.20 logMAR STANDARD_DEVIATION 0.12 • n=13 Participants	0.24 logMAR STANDARD_DEVIATION 0.27 • n=14 Participants	0.63 logMAR STANDARD_DEVIATION 0.53 • n=4 Participants	0.02 logMAR STANDARD_DEVIATION 0.15 • n=15 Participants	0.33 logMAR STANDARD_DEVIATION 0.42 • n=60 Participants

PRIMARY outcome

Timeframe: 6 months

Total time for each participant to complete the binocular optical coherence tomography (OCT) examination was calculated.

Outcome measures

Outcome measures
Measure	Retinal Disease n=14 Participants Fourteen participants had bilateral retinal disease only (including 8 with age-related macular degeneration \[AMD\], 4 with diabetic macular edema, 1 with central serous retinopathy, and 1 with retinal vein occlusion with cystoid macular edema).	Glaucoma n=13 Participants Thirteen participants had glaucoma only (12 with primary open angle glaucoma \[POAG\], 1 with glaucoma secondary to hypertensive uveitis).	Strabismus n=14 Participants Fourteen participants had strabismus only (7 with esotropia, 6 with exotropia, and 1 with hypertropia).	Ocular Comorbidities n=4 Participants Four participants had ocular comorbidities: two with bilateral POAG and AMD; one had unilateral POAG and a symptomatic epiretinal membrane in the fellow eye; and one had bilateral POAG and congenital convergent strabismus.	Healthy Volunteers n=15 Participants Fifteen healthy volunteers with no self-reported history of ocular disease.
Total Examination Time	728.6 seconds Interval 654.7 to 826.4	676.7 seconds Interval 626.4 to 747.7	707.6 seconds Interval 636.9 to 847.9	620.6 seconds Interval 598.1 to 753.7	637.8 seconds Interval 572.4 to 821.7

SECONDARY outcome

Timeframe: 6 months

Population: Results based on a post-test questionnaire. Participants rated ease of use (from 1 to 5: 1 = very difficult, 5 = very easy), duration (from 1 to 5: 1 = very long, 5 = very short), and appeal (from 1 to 5: 1 = very unappealing, 5 = very appealing) on a 5-point Likert scale.

Participants rated ease of use, duration, and appeal on a 5-point Likert scale in a post-test questionnaire.

Outcome measures

Outcome measures
Measure	Retinal Disease n=14 Participants Fourteen participants had bilateral retinal disease only (including 8 with age-related macular degeneration \[AMD\], 4 with diabetic macular edema, 1 with central serous retinopathy, and 1 with retinal vein occlusion with cystoid macular edema).	Glaucoma n=13 Participants Thirteen participants had glaucoma only (12 with primary open angle glaucoma \[POAG\], 1 with glaucoma secondary to hypertensive uveitis).	Strabismus n=14 Participants Fourteen participants had strabismus only (7 with esotropia, 6 with exotropia, and 1 with hypertropia).	Ocular Comorbidities n=4 Participants Four participants had ocular comorbidities: two with bilateral POAG and AMD; one had unilateral POAG and a symptomatic epiretinal membrane in the fellow eye; and one had bilateral POAG and congenital convergent strabismus.	Healthy Volunteers n=15 Participants Fifteen healthy volunteers with no self-reported history of ocular disease.
Number of Participants With Subjective Ratings ≥ 4 on Post-Test Questionnaire Rated ≥ 4 ease of use	9 Participants	11 Participants	12 Participants	2 Participants	13 Participants
Number of Participants With Subjective Ratings ≥ 4 on Post-Test Questionnaire Rated ≥ 4 duration	10 Participants	7 Participants	8 Participants	1 Participants	8 Participants
Number of Participants With Subjective Ratings ≥ 4 on Post-Test Questionnaire Rated ≥ 4 appeal	13 Participants	11 Participants	12 Participants	3 Participants	13 Participants

SECONDARY outcome

Timeframe: 4 months

To identify potential user errors, particularly those with a likelihood of generating erroneous examination findings (e.g., failure to comply with device instructions or errors in voice recognition).