Trial Outcomes & Findings for A New Approach to Vision Therapy Based on Naturalistic 3-D Computer Gaming (NCT NCT03066063)
NCT ID: NCT03066063
Last Updated: 2024-12-10
Results Overview
Pre- to post-intervention change in best-corrected vision measured using a logMAR (Logarithm of the Minimum Angle of Resolution) chart, which consists of rows of letters of different sizes. The scale ranges from -0.3 (approximately 20/10 vision on the Snellen chart) to 1 (approximately 20/200 vision). Lower scores indicate better vision.
COMPLETED
92 participants
Pre- to post-intervention change in best-corrected vision (delta-logMAR) at 12 weeks
2024-12-10
Participant Flow
Participant milestones
| Measure |
Amblyopia Standard of Care Group
A standard of care group will be prescribed patching for two or six hours per day, seven days per week. Standard of care group participants with best-corrected vision worse than 20/200 in their amblyopic eye will be prescribed six hours of patching daily, while participants whose best-corrected visual acuity is 20/200 or better will be prescribed two hours of patching daily.
Amblyopia standard of Care: The amblyopia standard of care group will be prescribed patching for two or six hours per day, seven days per week. Standard of care group participants with best-corrected vision worse than 20/200 in their amblyopic eye will be prescribed six hours of patching daily
|
Amblyopia iCare Group
Participants assigned to an experimental group will play iCare vision therapy games for approximately 20 minutes per day, five days per week.
iCare: The iCare product is an action video game designed to provide home-based vision therapy for non-strabismic amblyopia and convergence insufficiency in children as young as 4 years old. Participants assigned to an iCare group will play iCare vision therapy games for approximately 20 minutes per day, five days per week.
|
Convergence Insufficiency Standard of Care Group
A standard of care group for convergence insufficiency will perform pencil pushups for 20 minutes per day, five days per week.
CI standard of Care: A dosage-matched CI standard of Care group will be prescribed pencil pushups for 20 minutes per day, five days per week.
|
Convergence Insufficiency iCare Group
The iCare experimental group for convergence insufficiency will be prescribed vision therapy gameplay for approximately 20 minutes per day, five days per week.
iCare: The iCare product is an action video game designed to provide home-based vision therapy for non-strabismic amblyopia and convergence insufficiency in children as young as 4 years old. Participants assigned to an iCare group will play iCare vision therapy games for approximately 20 minutes per day, five days per week.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
24
|
25
|
19
|
24
|
|
Overall Study
COMPLETED
|
19
|
21
|
13
|
18
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
6
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A New Approach to Vision Therapy Based on Naturalistic 3-D Computer Gaming
Baseline characteristics by cohort
| Measure |
Amblyopia Standard of Care Group
n=24 Participants
A standard of care group will be prescribed patching for two or six hours per day, seven days per week. Standard of care group participants with best-corrected vision worse than 20/200 in their amblyopic eye will be prescribed six hours of patching daily, while participants whose best-corrected visual acuity is 20/200 or better will be prescribed two hours of patching daily.
Amblyopia standard of Care: The amblyopia standard of care group will be prescribed patching for two or six hours per day, seven days per week. Standard of care group participants with best-corrected vision worse than 20/200 in their amblyopic eye will be prescribed six hours of patching daily
|
Amblyopia iCare Group
n=25 Participants
Participants assigned to an experimental group will play iCare vision therapy games for approximately 20 minutes per day, five days per week.
iCare: The iCare product is an action video game designed to provide home-based vision therapy for non-strabismic amblyopia and convergence insufficiency in children as young as 4 years old. Participants assigned to an iCare group will play iCare vision therapy games for approximately 20 minutes per day, five days per week.
|
Convergence Insufficiency Standard of Care Group
n=19 Participants
A standard of care group for convergence insufficiency will perform pencil pushups for 20 minutes per day, five days per week.
CI standard of Care: A dosage-matched CI standard of Care group will be prescribed pencil pushups for 20 minutes per day, five days per week.
|
Convergence Insufficiency iCare Group
n=24 Participants
The iCare experimental group for convergence insufficiency will be prescribed vision therapy gameplay for approximately 20 minutes per day, five days per week.
iCare: The iCare product is an action video game designed to provide home-based vision therapy for non-strabismic amblyopia and convergence insufficiency in children as young as 4 years old. Participants assigned to an iCare group will play iCare vision therapy games for approximately 20 minutes per day, five days per week.
|
Total
n=92 Participants
Total of all reporting groups
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|---|---|---|---|---|---|
|
Age, Continuous
|
10 years
n=5 Participants
|
10 years
n=7 Participants
|
12 years
n=5 Participants
|
12 years
n=4 Participants
|
11 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
47 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
45 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
74 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
64 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
25 participants
n=7 Participants
|
19 participants
n=5 Participants
|
24 participants
n=4 Participants
|
92 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Pre- to post-intervention change in best-corrected vision (delta-logMAR) at 12 weeksPopulation: Per the study protocol and statistical analysis play, this measure only applies to the amblyopia arm of the study.
Pre- to post-intervention change in best-corrected vision measured using a logMAR (Logarithm of the Minimum Angle of Resolution) chart, which consists of rows of letters of different sizes. The scale ranges from -0.3 (approximately 20/10 vision on the Snellen chart) to 1 (approximately 20/200 vision). Lower scores indicate better vision.
Outcome measures
| Measure |
Amblyopia Standard of Care Group
n=19 Participants
A standard of care group will be prescribed patching for two or six hours per day, seven days per week. Standard of care group participants with best-corrected vision worse than 20/200 in their amblyopic eye will be prescribed six hours of patching daily, while participants whose best-corrected visual acuity is 20/200 or better will be prescribed two hours of patching daily.
Amblyopia standard of Care: The amblyopia standard of care group will be prescribed patching for two or six hours per day, seven days per week. Standard of care group participants with best-corrected vision worse than 20/200 in their amblyopic eye will be prescribed six hours of patching daily
|
Amblyopia iCare Group
n=21 Participants
Participants assigned to an experimental group will play iCare vision therapy games for approximately 20 minutes per day, five days per week.
iCare: The iCare product is an action video game designed to provide home-based vision therapy for non-strabismic amblyopia and convergence insufficiency in children as young as 4 years old. Participants assigned to an iCare group will play iCare vision therapy games for approximately 20 minutes per day, five days per week.
|
|---|---|---|
|
Visual Acuity
|
-0.12 change in logMAR
Standard Deviation 0.14
|
-0.13 change in logMAR
Standard Deviation 0.23
|
PRIMARY outcome
Timeframe: Pre- to post-intervention change in BOB (delta-BOB) at 12 weeksPopulation: Per the study protocol and statistical analysis play, this measure only applies to the convergence insufficiency arm of the study.
Cover Testing procedures were followed by evaluation of PFV at near using base-out prisms. A single column of 20/30 letters of the Gulden Fixation stick was advanced towards the subject from the distance of 40cm from the subject's eyes, while the subject continued fusing the letters (keeping them single) while viewing them through a corresponding prism. The magnitude of the prism was increased (for break point) and subsequently decreased (for recovery point) at a rate of about 2∆ /second. The procedure was repeated 3 times and the blinded examiner recorded blur, break and recovery points in prism diopters (∆). Larger numbers are better.
Outcome measures
| Measure |
Amblyopia Standard of Care Group
n=13 Participants
A standard of care group will be prescribed patching for two or six hours per day, seven days per week. Standard of care group participants with best-corrected vision worse than 20/200 in their amblyopic eye will be prescribed six hours of patching daily, while participants whose best-corrected visual acuity is 20/200 or better will be prescribed two hours of patching daily.
Amblyopia standard of Care: The amblyopia standard of care group will be prescribed patching for two or six hours per day, seven days per week. Standard of care group participants with best-corrected vision worse than 20/200 in their amblyopic eye will be prescribed six hours of patching daily
|
Amblyopia iCare Group
n=18 Participants
Participants assigned to an experimental group will play iCare vision therapy games for approximately 20 minutes per day, five days per week.
iCare: The iCare product is an action video game designed to provide home-based vision therapy for non-strabismic amblyopia and convergence insufficiency in children as young as 4 years old. Participants assigned to an iCare group will play iCare vision therapy games for approximately 20 minutes per day, five days per week.
|
|---|---|---|
|
Positive Fusional Vergence (PFV) Base-Out Breakpoint (BOB)
|
4.85 prism diopters
Standard Deviation 7.37
|
6.22 prism diopters
Standard Deviation 8.72
|
SECONDARY outcome
Timeframe: Pre- to post-intervention change at 12 weeksPopulation: Per the study protocol and statistical analysis play, this measure only applies to the convergence insufficiency arm of the study.
Near Point of Convergence was determined by slowly (1-2 cm/sec) moving a single column of 20/30 letters (Gulden fixation target) towards the bridge of the nose of the subject from a distance of 40 cm along the Astron International (ACR/21) Accommodative rule placed at the bridge of the subject's nose. The procedure was repeated 3 times and distances (cm) at which the target became blurry (blur), double (break) and back to single (recovery) were recorded. The testing was performed with the subject's regular optical correction (if worn). Larger numbers are better.
Outcome measures
| Measure |
Amblyopia Standard of Care Group
n=13 Participants
A standard of care group will be prescribed patching for two or six hours per day, seven days per week. Standard of care group participants with best-corrected vision worse than 20/200 in their amblyopic eye will be prescribed six hours of patching daily, while participants whose best-corrected visual acuity is 20/200 or better will be prescribed two hours of patching daily.
Amblyopia standard of Care: The amblyopia standard of care group will be prescribed patching for two or six hours per day, seven days per week. Standard of care group participants with best-corrected vision worse than 20/200 in their amblyopic eye will be prescribed six hours of patching daily
|
Amblyopia iCare Group
n=18 Participants
Participants assigned to an experimental group will play iCare vision therapy games for approximately 20 minutes per day, five days per week.
iCare: The iCare product is an action video game designed to provide home-based vision therapy for non-strabismic amblyopia and convergence insufficiency in children as young as 4 years old. Participants assigned to an iCare group will play iCare vision therapy games for approximately 20 minutes per day, five days per week.
|
|---|---|---|
|
Near Point of Convergence (NPC) at Break
|
-4.92 centimeters
Standard Deviation 7.56
|
-3.63 centimeters
Standard Deviation 6.99
|
SECONDARY outcome
Timeframe: Pre- to post-intervention change at 12 weeksPopulation: Per the study protocol and statistical analysis play, this measure only applies to the convergence insufficiency arm of the study.
A blinded examiner (i.e., optometrist) administered a Convergence Insufficiency Symptom Survey (CISS) to the patient. The CISS questionnaire assesses the severity of symptoms associated with convergence insufficiency, a binocular vision disorder, by asking individuals about eye strain, headaches, blurred vision, double vision, difficulty concentrating, and other issues that often arise when focusing on near objects. There are a total of 14 questions, with responses on a Likert scale scored from 0 to 4. The CISS is the sum, which can range from 0 to 56. Higher scores are worse. A total score equal to or greater than 16 is suggestive of convergence insufficiency.
Outcome measures
| Measure |
Amblyopia Standard of Care Group
n=13 Participants
A standard of care group will be prescribed patching for two or six hours per day, seven days per week. Standard of care group participants with best-corrected vision worse than 20/200 in their amblyopic eye will be prescribed six hours of patching daily, while participants whose best-corrected visual acuity is 20/200 or better will be prescribed two hours of patching daily.
Amblyopia standard of Care: The amblyopia standard of care group will be prescribed patching for two or six hours per day, seven days per week. Standard of care group participants with best-corrected vision worse than 20/200 in their amblyopic eye will be prescribed six hours of patching daily
|
Amblyopia iCare Group
n=18 Participants
Participants assigned to an experimental group will play iCare vision therapy games for approximately 20 minutes per day, five days per week.
iCare: The iCare product is an action video game designed to provide home-based vision therapy for non-strabismic amblyopia and convergence insufficiency in children as young as 4 years old. Participants assigned to an iCare group will play iCare vision therapy games for approximately 20 minutes per day, five days per week.
|
|---|---|---|
|
Convergence Insufficiency Symptom Survey (CISS)
|
-12.00 score on a scale
Standard Deviation 10.84
|
-9.00 score on a scale
Standard Deviation 10.45
|
Adverse Events
Amblyopia Standard of Care Group
Amblyopia iCare Group
Convergence Insufficiency Standard of Care Group
Convergence Insufficiency iCare Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place