Trial Outcomes & Findings for Comparison of AmblyzTM Glasses and Patching for Amblyopia (NCT NCT01973348)

Results Overview

Visual acuity change during 12 weeks: the difference of visual acuity at baseline and 12 weeks.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

12 weeks

Results posted on

2017-08-25

Participant Flow

49 patients were consented; 45 entered the trial, with 27 assigned to the IO therapy group and 18 to the patching group.

49 patients were consented; 4 patients were not qualified. 45 entered the trial, with 27 assigned to the IO therapy group and 18 to the patching group

Participant milestones

Participant milestones
Measure	4-hour AmblyZ Glasses 4-hour AmblyZ glasses for moderate amblyopia 4-hour AmblyZ glasses: 4-hour AmblyZ glasses for moderate amblyopia	2-hour Eye Patching 2-hour eye patching for moderate amblyopia 2-hour patching: 2-hour patching for moderate amblyopia
Overall Study STARTED	27	18
Overall Study COMPLETED	19	15
Overall Study NOT COMPLETED	8	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of AmblyzTM Glasses and Patching for Amblyopia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	4-hour AmblyZ Glasses n=19 Participants 4-hour AmblyZ glasses for moderate amblyopia 4-hour AmblyZ glasses: 4-hour AmblyZ glasses for moderate amblyopia	2-hour Eye Patching n=15 Participants 2-hour eye patching for moderate amblyopia 2-hour patching: 2-hour patching for moderate amblyopia	12-hour AmblyZ Glasses 12-hour AmblyZ glasses for severe amblyopia 12-hour AmblyZ glasses: 12-hour AmblyZ glasses for severe amblyopia	6-hour Eye Patching 6-hour eye patching for severe amblyopia 6-hour patching: 6-hour patching for severe amblyopia	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	19 Participants n=5 Participants	15 Participants n=7 Participants	—	—	34 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	—	—	0 Participants n=21 Participants
Age, Continuous	5.7 year old STANDARD_DEVIATION 1.5 • n=5 Participants	5.9 year old STANDARD_DEVIATION 0.9 • n=7 Participants	—	—	5.8 year old STANDARD_DEVIATION 1.2 • n=21 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	—	—	12 Participants n=21 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	8 Participants n=7 Participants	—	—	22 Participants n=21 Participants
Region of Enrollment United States	19 participants n=5 Participants	15 participants n=7 Participants	—	—	34 participants n=21 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Visual acuity change over 12 weeks

Visual acuity change during 12 weeks: the difference of visual acuity at baseline and 12 weeks.

Outcome measures

Outcome measures
Measure	4-hour AmblyZ Glasses n=19 Participants 4-hour AmblyZ glasses for moderate amblyopia 4-hour AmblyZ glasses: 4-hour AmblyZ glasses for moderate amblyopia	2-hour Eye Patching n=15 Participants 2-hour eye patching for moderate amblyopia 2-hour patching: 2-hour patching for moderate amblyopia	12-hour AmblyZ Glasses 12-hour AmblyZ glasses for severe amblyopia 12-hour AmblyZ glasses: 12-hour AmblyZ glasses for severe amblyopia	6-hour Eye Patching 6-hour eye patching for severe amblyopia 6-hour patching: 6-hour patching for severe amblyopia
Visual Acuity Change During 12 Weeks	.15 logMAR Standard Deviation .12	.15 logMAR Standard Deviation .11	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months

it is defined that the strong eye of the patient decreases two logMAR lines over 3 months.

Outcome measures

Outcome measures
Measure	4-hour AmblyZ Glasses n=19 Participants 4-hour AmblyZ glasses for moderate amblyopia 4-hour AmblyZ glasses: 4-hour AmblyZ glasses for moderate amblyopia	2-hour Eye Patching n=15 Participants 2-hour eye patching for moderate amblyopia 2-hour patching: 2-hour patching for moderate amblyopia	12-hour AmblyZ Glasses 12-hour AmblyZ glasses for severe amblyopia 12-hour AmblyZ glasses: 12-hour AmblyZ glasses for severe amblyopia	6-hour Eye Patching 6-hour eye patching for severe amblyopia 6-hour patching: 6-hour patching for severe amblyopia
Reverse Amblyopia	0 Participants	0 Participants	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months

The significant ocular deviation is defined as equal or over 10 degrees of deviation more than that of the baseline.

Outcome measures

Outcome measures
Measure	4-hour AmblyZ Glasses n=19 Participants 4-hour AmblyZ glasses for moderate amblyopia 4-hour AmblyZ glasses: 4-hour AmblyZ glasses for moderate amblyopia	2-hour Eye Patching n=15 Participants 2-hour eye patching for moderate amblyopia 2-hour patching: 2-hour patching for moderate amblyopia	12-hour AmblyZ Glasses 12-hour AmblyZ glasses for severe amblyopia 12-hour AmblyZ glasses: 12-hour AmblyZ glasses for severe amblyopia	6-hour Eye Patching 6-hour eye patching for severe amblyopia 6-hour patching: 6-hour patching for severe amblyopia
Significant Ocular Deviation Increase From the Baseline	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

4-hour AmblyZ Glasses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2-hour Eye Patching

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

12-hour AmblyZ Glasses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

6-hour Eye Patching

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

Dr. Daniel Neely, PI

Indiana University

Phone: 3172741214

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place