To compare the efficacy of 1 hour/day of binocular game play 5 days per week plus spectacle correction with spectacle correction only, for treatment of amblyopia in children 4 to \<13 years of age.
The purpose of the study is to compare the efficacy of 1 hour/day of binocular game play 5 days per week plus spectacle correction with spectacle correction only, for treatment of amblyopia in children 4 to \<13 years of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
320
Binocular therapy using a Dig Rush application on an iPad®
Spectacle correction for all waking hours, 7 days per week
Mean Change in Amblyopic-eye Visual Acuity (VA) Older Cohort
The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up. Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.
Time frame: Baseline and 4 weeks
Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort)
Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.
Time frame: 4 weeks
Mean Change in Amblyopic-eye Visual Acuity (VA) in Older Cohort
Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.
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UAB Pediatric Eye Care; Birmingham Health Care
Birmingham, Alabama, United States
Midwestern University Eye Institute
Glendale, Arizona, United States
University Eye Center at Ketchum Health
Anaheim, California, United States
Loma Linda University Health Care, Dept. of Ophthalmology
Loma Linda, California, United States
Saddleback Eye Medical Associates
Mission Viejo, California, United States
Western University College of Optometry
Pomona, California, United States
Yale University
New Haven, Connecticut, United States
Nova Southeastern University College of Optometry, The Eye Institute
Fort Lauderdale, Florida, United States
University of Florida Shands Hospital
Gainesville, Florida, United States
The Emory Eye Center
Atlanta, Georgia, United States
...and 52 more locations
Time frame: Baseline and 8 weeks
Mean Visual Acuity (VA) in Amblyopic-eye (Older Cohort)
Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the older cohort, the level of VA is measured as letter scores (approximate range: 0 to 97 letters, lower scores indicate poorer VA) and change in VA from baseline is measured in letters (positive values indicate improvement), defined as the difference in letter scores between enrollment and follow-up.
Time frame: 8 weeks
Mean Change in Amblyopic-eye Visual Acuity (VA) Younger Cohort
The primary objective is to compare the efficacy of 4 weeks of treatment with 1 hour/day of binocular game play 5 days per week plus spectacle correction to treatment with spectacle correction alone (control). Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up. Adjusted values have been adjusted for amblyopic-eye visual acuity at randomization.
Time frame: baseline and 4 weeks
Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort)
Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.
Time frame: 4 weeks
Mean Change in Amblyopic-eye Visual Acuity (VA) in Younger Cohort
Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.
Time frame: Baseline and 8 weeks
Mean Visual Acuity (VA) in Amblyopic-eye (Younger Cohort)
Monocular distance visual acuity (VA) in current refractive correction (if required) in each eye by a certified examiner using the Electronic Early Treatment Diabetic Retinoscopy Study (E-ETDRS) visual acuity protocol for children ≥ 7 years on a study-certified acuity tester displaying single surrounded optotypes. For the analyses in the younger cohort, the level of VA is measured in logMAR (approximate range: -0.2 to 1.2, lower scores indicate better VA) and change in VA from baseline is measured in logMAR lines (positive values indicate improvement), defined as 10 times the difference in logMAR between enrollment and follow-up.
Time frame: 8 weeks
VA Improvement at 4 Weeks Defined as a Binary Outcome
A secondary analysis will estimate the proportion of subjects with amblyopic-eye VA improvement of ≥ 2 logMAR lines (≥ 10 letters if E-ETDRS) at 4 weeks after baseline.
Time frame: At 4 weeks
VA Improvement at 8 Weeks Defined as a Binary Outcome
A secondary analysis will estimate the proportion of subjects with amblyopic-eye VA improvement of ≥ 2 logMAR lines (≥ 10 letters if E-ETDRS) at 8 weeks after baseline.
Time frame: At 8 weeks
Distribution of Stereoacuity Scores at 4 Weeks
Stereoacuity will be tested at near in current refractive correction using the Randot Butterfly and Randot Preschool stereoacuity tests. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.
Time frame: 4 weeks
Distribution of Change in Stereoacuity Scores From Baseline
Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 4-week stereoacuity scores.
Time frame: 4 weeks
Distribution of Stereoacuity Scores at 8 Weeks
Stereoacuity will be tested at near in current refractive correction using the Randot Butterfly and Randot Preschool stereoacuity tests. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.
Time frame: 8 weeks
Distribution of Change in Stereoacuity Scores From Baseline
Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 8-week stereoacuity scores.
Time frame: 8 weeks
Distribution of Stereoacuity Scores (Participants With no History of Strabismus)
Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.
Time frame: 4 weeks
Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus)
Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 4-week stereoacuity scores.
Time frame: 4 weeks
Distribution of Stereoacuity Scores (Participants With no History of Strabismus)
Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (measure as seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 seconds of arc (if correct response). Nil was assigned a score of 4000 seconds of arc and was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted.
Time frame: 8 weeks
Distribution of Change in Stereoacuity Scores From Baseline (Participants With no History of Strabismus)
Stereoacuity was tested at near in current refractive correction. Stereoacuity scores (seconds of arc) were calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) test methods. Lower scores indicate better stereoacuity. Results of the Randot Butterfly test were analyzed as 2000 (if correct response). Nil (4000) was defined as (1) an incorrect response on the butterfly in absence of a correct response on the 800 seconds of arc level of the Randot Preschool stereoacuity test or (2) an incorrect response on the 800 seconds of arc level if the butterfly was not attempted. For each visit, stereoacuity scores were ordered and assigned a rank score. Change in stereoacuity was calculated as the difference in ranked score between the enrollment and 4-week stereoacuity scores.
Time frame: 8 weeks
Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast
Data from the automated iPad log files will be used to provide an objective measure of compliance with binocular treatment (participants completion of \>75% of prescribed game play). The total amount of game play will be computed for the initial 4 weeks of treatment for the binocular treatment group, as well as throughout 8 weeks. Secondary analyses will evaluate the relationship between the total amount of game play with (1) change in VA and (2) change in stereoacuity after the first 4 weeks of binocular treatment. Data from the automated iPad log files will also be used to assess game performance as measured by the fellow-eye contrast.
Time frame: 4 weeks
Binocular Therapy: Treatment Compliance and Fellow-Eye Contrast
Data from the automated iPad log files will be used to assess game performance as measured by the fellow-eye contrast. The level and change in fellow-eye contrast will be computed for the initial 4 weeks of treatment for the binocular treatment group. Secondary analyses will evaluate the relationship between the change in fellow-eye contrast with (1) change in VA and (2) change in stereoacuity after the first 8 weeks of binocular treatment. Data from the automated iPad log files will also be used to assess game performance as measured by the fellow-eye contrast.
Time frame: 8 weeks
Treatment Compliance With Spectacle Wear
Parent-reported adherence with spectacle wear (excluding participants with reported compliance of 'N/A') for the initial 4 weeks. Patient reported to have completed \>75% of spectacle wear at 4 weeks.
Time frame: 4 weeks
Treatment Compliance With Spectacle Wear
Parent-reported adherence with spectacle wear (excluding participants with reported compliance of 'N/A') across 8 weeks. Patient reported to have completed \>75% of spectacle wear at 8 weeks.
Time frame: 8 weeks
Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Older Cohort)
The mean change in fellow-eye VA from baseline to 4 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.
Time frame: Baseline and 4 weeks
Mean Change in Fellow Eye VA at 8 Weeks (Older Cohort)
The mean change in fellow-eye VA from baseline to 8 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.
Time frame: Baseline and 8 weeks
Ocular Alignment at 4 Weeks
The proportion of subjects with development of new strabismus (no heterotropia at baseline and the presence of near and/or distance heterotropia at 4 weeks) or an increase from baseline ≥10∆ in a pre-existing strabismus at 4 weeks will be reported by treatment group and compared using Barnard's exact test. Ocular alignment will be assessed in current refractive correction by the cover/uncover test, simultaneous prism and cover test (SPCT), and prism and alternate cover test (PACT) in primary gaze at distance (3 meters) and at near (1/3 meter). Participants were classified according to whether they met the any of the following criteria at the 4-week visit: development of a new tropia (measured by SPCT) and/or worsening of a pre-existing deviation by 10 prism diopters (pd) measured by SPCT.
Time frame: 4 weeks
Ocular Alignment at 8 Weeks
The proportion of subjects with development of new strabismus (no heterotropia at baseline and the presence of near and/or distance heterotropia at 8 weeks) or an increase from baseline ≥10∆ in a pre-existing strabismus at 8 weeks will be reported by treatment group and compared using Barnard's exact test. Ocular alignment will be assessed in current refractive correction by the cover/uncover test, simultaneous prism and cover test (SPCT), and prism and alternate cover test (PACT) in primary gaze at distance (3 meters) and at near (1/3 meter). Participants were classified according to whether they met the any of the following criteria at the 8-week visit: development of a new tropia (measured by SPCT) and/or worsening of a pre-existing deviation by 10 prism diopters (pd) measured by SPCT.
Time frame: 8 weeks
Distribution of Diplopia Frequency at 4 Weeks (Participant-reported)
The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 4 weeks. A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.
Time frame: 4 weeks
Distribution of Diplopia Frequency at 8 Weeks (Participant-reported)
The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 8 weeks. A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.
Time frame: 8 weeks
Change in Diplopia Frequency From Baseline to 4 Weeks (Participant-reported)
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 4 weeks was reported categorically.
Time frame: 4 weeks
Change in Diplopia Frequency From Baseline to 8 Weeks (Participant-reported)
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 8 weeks was reported categorically.
Time frame: 8 weeks
Distribution of Diplopia Frequency at 4 Weeks (Parent-reported)
The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 4 weeks. A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.
Time frame: 4 weeks
Distribution of Diplopia Frequency at 8 Weeks (Parent-reported)
The proportion of subjects with each level of diplopia frequency will be reported by treatment group at 8 weeks. A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit.
Time frame: 8 weeks
Change in Diplopia Frequency From Baseline to 4 Weeks (Parent-reported)
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 4 weeks was reported categorically.
Time frame: 4 weeks
Change in Diplopia Frequency From Baseline to 8 Weeks (Parent-reported)
A standardized questionnaire was administered to participants and their parents to assess the presence and frequency of any diplopia since the last study visit. Change in diplopia frequency from baseline to 8 weeks was reported categorically.
Time frame: 8 weeks
Frequency of Adverse Symptoms (Symptom Survey)
The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 4-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.
Time frame: 4 weeks
Frequency of Adverse Symptoms (Symptom Survey) at 8 Weeks
The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 4-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.
Time frame: 8 weeks
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 4 Weeks
The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 4-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.
Time frame: 4 weeks
Distribution of Change in Adverse Symptom Frequency (Symptom Survey) From Baseline to 8 Weeks
The child and parent(s) will complete a 5-item symptom survey regarding the presence of various ocular symptoms within the past 2 weeks at enrollment and at each visit. The distribution of scores on each symptom survey item will be described for the enrollment exam and the 8-week exam for each treatment group. The distribution of change in scores on each symptom survey item will also be described for each treatment group.
Time frame: 8 weeks
Mean Change in Fellow Eye Visual Acuity at 4 Weeks (Younger Cohort)
The mean change in fellow-eye VA from baseline to 4 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.
Time frame: Baseline and 4 weeks
Mean Change in Fellow Eye VA at 8 Weeks (Younger Cohort)
The mean change in fellow-eye VA from baseline to 8 weeks will be calculated and compared between treatment groups using ANCOVA with adjustment for baseline VA.
Time frame: baseline and 8 weeks