This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Study of Binocular Computer Activities for Treatment of Amblyopia (NCT02200211), a randomized na study. The primary outcome is Change in Distance Visual Acuity From Baseline in the Younger Cohort (5 to <13 Years).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02200211 |
| Phase | NA |
| Condition | Amblyopia |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 485 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Jaeb Center for Health Research |
| Results posted | Yes |
2. Clinical Question
Population
Children with amblyopia, with the study’s brief description covering ages 5 to <17. The primary endpoint concerns the younger cohort, defined as ages 5 to <13. Visual-acuity analyses used participants who completed the 16-week visit within the specified analysis window.
Intervention
Binocular computer-game play on an iPad® for 1 hour per day, 7 days per week. The arm description also specifies a minimum of 4 days per week.
Comparator
Patching for 2 hours per day, 7 days per week.
Primary question
For the younger cohort, what was the change from baseline to 16 weeks in distance visual acuity, measured in logMAR lines, under binocular treatment compared with patching?
The study was designed to compare two treatment schedules using a visual measure of amblyopic-eye acuity. Its primary endpoint is not a general measure of vision in daily life: it is a protocol-based assessment of monocular distance visual acuity, performed in each eye by a certified examiner. The registry describes the trial’s overall purpose as comparing binocular game play with patching in children.
The primary question is specific to the younger cohort, ages 5 to <13, even though the broader study description covers children 5 to <17 and the record also refers to an older cohort. The numerical primary results, including the estimated contrast between treatment groups and its precision, are not reported in the registry record. The posted information therefore identifies what the study set out to compare, but does not establish the size or direction of the observed difference.
3. Trial Design
The registry record describes a randomized, single-masked, parallel-group study of binocular computer activities for amblyopia. It lists an enrollment of 485 and identifies Jaeb Center for Health Research as the sponsor. The study status is completed; the listed start date is 2014-09-11 and the primary completion date is 2016-08-19. The phase is listed as NA.
The two treatment groups differed in the activity and scheduled daily duration. The binocular-treatment arm used computer-game play for 1 hour per day, 7 days per week, with a stated minimum of 4 days per week. The comparison arm used patching for 2 hours per day, 7 days per week. The interventions are listed as an iPad® device and patching. The record identifies randomization and a parallel model, but does not report the randomization procedure, allocation concealment, or the identity of the person or people masked.
The primary outcome concerns change in distance visual acuity in the younger cohort, ages 5 to <13, from baseline to 16 weeks. The record also lists outcomes addressing acuity improvement, resolution of amblyopia, time course, subgroup changes in younger and older cohorts, and stereoacuity. It lists 28 outcome measures and 40 analyses. Those counts indicate that the registry covers multiple outcomes and analyses; they do not, by themselves, specify which analyses were prespecified as confirmatory or how multiplicity was handled.
The visual-acuity analysis was restricted to participants who completed the 16-week visit within the predefined window of 14 to <20 weeks after randomization. The primary analysis is described as adjusted for baseline age and visual acuity. More detail about the statistical analysis plan, including any additional covariates or allocation details, is not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Binocular Treatment Younger | Patching Treatment Younger | Binocular Treatment Older | Patching Treatment Older |
|---|---|---|---|---|
| STARTED | 190 | 195 | 40 | 60 |
| Included in 16-week Primary Analysis | 177 | 186 | 39 | 56 |
| COMPLETED | 182 | 188 | 39 | 58 |
| NOT COMPLETED | 8 | 7 | 1 | 2 |
Reasons for not completing this period:
| Reason | Binocular Treatment Younger | Patching Treatment Younger | Binocular Treatment Older | Patching Treatment Older |
|---|---|---|---|---|
| Lost to Follow-up | 7 | 7 | 1 | 2 |
| Withdrawal by Subject | 1 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Visual acuity analyses included only data from participants who completed the 16-week visit within the predefined analysis window (14 to \<20 weeks after randomization), analysis is adjusted for baseline covariates of age and visual acuity.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Binocular Treatment Younger Cohort (5 to <13 Years) | Patching Treatment Younger Cohort (5 to <13 Years) | Binocular Treatment Older Cohort (13 to <17 Years) | Patching Treatment Older Cohort (13 to <17 Years) | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 190 | 195 | 40 | 60 | 485 | |
| Age, Categorical: <=18 years | Participants | 190 | 195 | 40 | 60 | 485 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 0 | 0 | 0 | 0 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous | years | 8.4 (SD 1.8) | 8.6 (SD 2.0) | 14.3 (SD 1.1) | 14.3 (SD 1.1) | 9.7 (SD 2.9) |
| Age, Customized: Age at enrollment, years : 5 to <7 | Participants | 43 | 50 | 0 | 0 | 93 |
| Age, Customized: Age at enrollment, years : 7 to <9 | Participants | 78 | 62 | 0 | 0 | 140 |
| Age, Customized: Age at enrollment, years : 9 to <13 | Participants | 69 | 83 | 0 | 0 | 152 |
| Age, Customized: Age at enrollment, years : 13 to <17 | Participants | 0 | 0 | 40 | 60 | 100 |
| Sex: Female, Male: Female | Participants | 98 | 89 | 16 | 26 | 229 |
| Sex: Female, Male: Male | Participants | 92 | 106 | 24 | 34 | 256 |
| Race/Ethnicity, Customized: White | Participants | 134 | 145 | 30 | 43 | 352 |
| Race/Ethnicity, Customized: Black/African American | Participants | 11 | 12 | 2 | 4 | 29 |
| Race/Ethnicity, Customized: Hispanic or Latino | Participants | 33 | 24 | 8 | 11 | 76 |
| Race/Ethnicity, Customized: Asian, American Indian, Alaskan Native | Participants | 9 | 6 | 0 | 1 | 16 |
| Race/Ethnicity, Customized: >1 Race | Participants | 2 | 5 | 0 | 1 | 8 |
| Race/Ethnicity, Customized: Unknown/not reported | Participants | 1 | 3 | 0 | 0 | 4 |
| Distance Amblyopic-Eye Visual Acuity: 20/200 (33-37 Letters) | Participants | 5 | 4 | 0 | 2 | 11 |
| Distance Amblyopic-Eye Visual Acuity: 20/160 (38-42 Letters) | Participants | 6 | 7 | 2 | 5 | 20 |
| Distance Amblyopic-Eye Visual Acuity: 20/125 (43-47 Letters) | Participants | 8 | 4 | 4 | 8 | 24 |
| Distance Amblyopic-Eye Visual Acuity: 20/100 (48-52 Letters) | Participants | 16 | 12 | 3 | 4 | 35 |
| Distance Amblyopic-Eye Visual Acuity: 20/80 (53-57 Letters) | Participants | 30 | 24 | 7 | 12 | 73 |
| Distance Amblyopic-Eye Visual Acuity: 20/63 (58-62 Letters) | Participants | 37 | 46 | 6 | 10 | 99 |
| Distance Amblyopic-Eye Visual Acuity: 20/50 (63-67 Letters) | Participants | 61 | 52 | 12 | 14 | 139 |
| Distance Amblyopic-Eye Visual Acuity: 20/40 (68-72 Letters) | Participants | 27 | 46 | 6 | 5 | 84 |
| Baseline Stereoacuity (Seconds of Arc): 4000 | Participants | 69 | 57 | 16 | 29 | 171 |
| Baseline Stereoacuity (Seconds of Arc): 2000 | Participants | 28 | 37 | 3 | 7 | 75 |
| Baseline Stereoacuity (Seconds of Arc): 800 | Participants | 18 | 26 | 5 | 4 | 53 |
| Baseline Stereoacuity (Seconds of Arc): 400 | Participants | 17 | 19 | 7 | 7 | 50 |
| Baseline Stereoacuity (Seconds of Arc): 200 | Participants | 23 | 18 | 2 | 4 | 47 |
| Baseline Stereoacuity (Seconds of Arc): 100 | Participants | 23 | 23 | 6 | 6 | 58 |
| Baseline Stereoacuity (Seconds of Arc): 60 | Participants | 10 | 9 | 1 | 1 | 21 |
| Baseline Stereoacuity (Seconds of Arc): 40 | Participants | 2 | 6 | 0 | 2 | 10 |
| Baseline Stereoacuity (Seconds of Arc): All participants | Seconds of Arc | 2000 (40 to 4000) | 800 (40 to 4000) | 800 (60 to 4000) | 2000 (40 to 4000) | NA (40 to 4000) |
| Baseline Stereoacuity (Seconds of Arc): Participants with no history of strabismus | Seconds of Arc | 400 (40 to 4000) | 400 (40 to 4000) | 400 (60 to 4000) | 800 (60 to 4000) | NA (40 to 4000) |
| Amblyopia Cause: Strabismus | Participants | 22 | 44 | 5 | 9 | 80 |
| Amblyopia Cause: Anisometropia | Participants | 107 | 92 | 22 | 29 | 250 |
| Amblyopia Cause: Strabismus/anisometropia combined | Participants | 61 | 59 | 13 | 22 | 155 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Distance Visual Acuity From Baseline in the Younger Cohort (5 to <13 Years), measured over Baseline and 16 weeks.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | LogMAR lines |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is change in distance visual acuity from baseline to 16 weeks in the younger cohort, defined as ages 5 to <13. Acuity was assessed monocularly in each eye, in current refractive correction if required, by a certified examiner using the study’s specified visual-acuity protocols. The ATS-HOTV protocol was used for children <7 years, and the E-ETDRS protocol for children ≥ 7 years, on a study-certified acuity tester displaying single surrounded optotypes.
The measure is expressed in logMAR lines. The registry explains that higher logMAR scores represent poorer visual acuity, while positive values for the change measure indicate improvement. Change is defined from the difference between enrollment and 16-week acuities, expressed in logMAR and multiplied by 10. The reported summary is a mean with a 95% confidence interval.
This endpoint is useful for comparing groups because it translates protocol-based acuity assessments into a continuous measure of change over the treatment period. A continuous outcome can retain information about the amount of change rather than reducing every participant to a category such as improved or not improved. The endpoint is specific to distance acuity and the stated assessment procedures; it does not alone describe every aspect of visual function. Numerical results for this endpoint are not reported in the registry record, so the size and precision of any group contrast cannot be assessed from the posted information.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically interpretable primary outcome and an intended comparison between randomized groups, but it does not report numerical results for the primary endpoint. In particular, the posted information does not give the mean change in either group, the between-group estimate, or a confidence interval for that contrast. It is therefore not possible to describe the observed direction or magnitude of the difference, or how precisely it was estimated. Those conclusions require the results themselves, not only the endpoint definition and analysis description.
The outcome is change in logMAR lines from baseline to 16 weeks in the younger cohort. The registry states that positive change values indicate improvement and that higher logMAR scores at a given assessment indicate poorer acuity. These conventions are important when reading any result: the sign of a change score is interpreted according to the registry’s definition, rather than assumed from a generic change-score convention. The posted record does not give the numerical group results needed to apply that interpretation.
The primary analysis is described as adjusted for age and visual acuity at baseline. Adjustment can account for the specified baseline covariates when estimating the outcome contrast. The record does not report the model form, the adjusted estimate, its confidence interval, or a p-value. It also does not state whether the adjusted analysis was accompanied by other analyses or sensitivity checks. The adjustment description alone does not establish whether the groups differed after treatment.
A confidence interval, as a general statistical concept, expresses the uncertainty around an estimated quantity under the assumptions of the analysis. A narrower interval indicates greater precision than a wider interval, while an interval’s location conveys the range of values compatible with the estimate and method. The registry names a 95% confidence interval as the dispersion measure for the mean, but does not post the primary numerical interval in the record. Without the interval and its associated estimate, precision cannot be judged.
The restriction to participants completing the 16-week visit within the predefined window affects how the primary analysis population is understood. The record does not state how many participants contributed to that analysis or how participants without an in-window assessment were handled. Thus, the total enrollment of 485 should not be treated as the endpoint analysis denominator. The consequences of incomplete follow-up for the estimated group comparison cannot be evaluated from the registry description alone.
The record includes several additional outcomes, spanning acuity, amblyopia resolution, time course, subgroup changes, and stereoacuity. Such breadth can provide multiple perspectives on the measured response, but it also means that an isolated result would need to be read in the context of the full analysis plan and the handling of multiple comparisons. The record lists 28 outcome measures and 40 analyses, but does not report a multiplicity adjustment or identify which comparisons were designated as primary, secondary, or exploratory beyond the listed primary endpoint. The results for those outcomes are not reported in the registry record details available for this account.
The safety entries list zero serious adverse events and zero other adverse events in each of the four displayed groups. These counts are descriptive and do not establish that no adverse events could occur, nor do they resolve whether the groups had similar safety profiles over all relevant follow-up. Death counts are not reported in the registry record. Overall, the posted record defines the comparison and endpoint, but lacks the outcome estimates needed to draw statistical conclusions about efficacy or precision.
9. Statistical Methods Explained
What does the endpoint measure?
The primary measure is a continuous outcome: change in distance visual acuity from baseline to 16 weeks, expressed in logMAR lines. The registry states that this is summarized as a mean with a 95% confidence interval. A continuous measure preserves the degree of change on the scale, rather than representing every participant only as reaching or not reaching a threshold. The record also lists a secondary outcome for participants with an acuity improvement of 2 or more logMAR lines, but that threshold outcome is distinct from the primary continuous measure.
The scale direction and change-score convention both matter. Higher logMAR scores represent poorer acuity, while positive values of the defined change score represent improvement. When reading a reported estimate, the reader would therefore need to distinguish the acuity score at an assessment from the change score derived from baseline and the 16-week assessment. Numerical primary estimates are not reported in the registry record.
Why report a mean and confidence interval?
As a general statistical explanation, the mean describes the central level of a continuous outcome for a group. A confidence interval communicates uncertainty around an estimated mean or contrast, conditional on the analysis method and its assumptions. It is not a guarantee that the true value lies within the particular interval, and it does not substitute for reporting the estimate itself. The registry specifies a 95% confidence interval, but the interval values and the treatment-group contrast are not reported in the registry record.
For a treatment comparison, the estimate of the difference between groups is usually more directly relevant than a separate description of each group’s change. A confidence interval around that contrast would show both its direction and the range of values compatible with the analysis. The record describes an adjusted primary analysis but does not give the adjusted contrast or its confidence interval. No significance test result for the primary comparison is reported in the registry record.
What does adjustment mean in this study?
The registry says that the primary analysis is adjusted for baseline age and visual acuity. In general, covariate adjustment uses specified baseline characteristics in the analysis to account for their relationship with the outcome and to estimate a treatment contrast conditional on those variables. Baseline adjustment can be useful when a prognostic characteristic is related to the measured endpoint. It does not change the endpoint’s definition, and it does not by itself establish that an observed treatment contrast is clinically important.
The record does not describe the model used to make this adjustment, how continuous variables were represented, whether any interactions were included, or whether other covariates were considered. Those details are not reported in the registry record. The adjusted result, if available, should be interpreted according to the fitted model and the analysis population; neither the model specification nor the numerical result is posted in the registry information.
How should the visit window be understood?
The primary visual-acuity analysis includes participants who completed the 16-week visit within the predefined window of 14 to <20 weeks after randomization. A visit window allows assessments made within a specified range of follow-up times to contribute to the endpoint. In general, defining such a window can make the intended timing explicit, while also meaning that assessments outside the window may not be included in that particular analysis. The registry does not report how many participants met this criterion, whether out-of-window measurements were used in other analyses, or how missing assessments were handled.
The primary analysis population is therefore described by visit completion rather than simply by enrollment. The record does not say that every randomized participant contributed to the primary endpoint. It also does not describe an imputation method, a missing-data model, or a sensitivity analysis for participants without a qualifying visit. These omissions limit assessment of how incomplete follow-up might affect the estimate.
What can be inferred from the planning illustration?
As a general statistical concept, a sample-size calculation asks how many participants may be needed to detect a prespecified effect under assumptions about the analysis and design. The planning illustration associated with this trial is described as based on the observed effect, with a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. The effect to detect is defined as a stated fraction of the observed effect. These are planning assumptions, not evidence that the trial was designed using those assumptions.
The record specifically characterizes this calculation as a planning illustration rather than the trial’s own design. It should not be interpreted as observed power, which is not a useful substitute for the uncertainty shown by a confidence interval around an estimated effect. A planning calculation based on an observed effect is also dependent on that effect estimate; if the estimate is imprecise, the resulting illustration inherits that uncertainty. The numerical planning outputs and the trial’s actual sample-size justification are not reported in the registry record details.
For a continuous outcome, a normal approximation is a model-based simplification used for planning. The usefulness of any such illustration depends on its assumptions matching the intended comparison and outcome distribution. Equal allocation is an assumption for the illustration; the registry does not report the actual allocation ratio or the design-stage sample-size rationale. No claim about power or adequacy of the completed enrollment can be made from the planning assumptions alone.
Why are multiple outcomes and analyses relevant?
The registry lists 28 outcome measures and 40 analyses, including the primary endpoint and outcomes addressing other aspects of acuity and stereoacuity. In general, examining many endpoints or comparisons creates opportunities for chance findings, particularly if results are selected after inspection. Statistical methods for multiplicity can control error rates across a defined family of tests, but the appropriate method depends on which comparisons are treated as confirmatory and how they are organized.
The registry information does not describe a multiplicity procedure, a testing hierarchy, or the complete statistical analysis plan. The counts alone do not establish that every analysis was a separate hypothesis test, nor do they tell the reader how results should be prioritized. A defensible interpretation would need the full prespecified plan and the results for the primary and relevant secondary outcomes. The posted information identifies the endpoint and several analysis features, but does not provide those details or numerical outcome results.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 28 outcome measures and 40 analyses. The outcomes include the primary change in distance visual acuity for the younger cohort, as well as acuity improvement, resolution of amblyopia, time course, subgroup analyses, and stereoacuity measures. Multiple measures and analyses can raise multiplicity concerns when several hypotheses are tested or when emphasis is placed selectively on favorable results. As a general statistical principle, multiplicity methods require a clearly defined family of comparisons and a prespecified approach.
A multiplicity adjustment, testing hierarchy, or other plan for controlling the interpretation of multiple analyses is not reported in the registry record. The listed counts do not establish how many formal tests were performed or which analyses were considered confirmatory. The primary endpoint is identified, but the registry description does not provide enough detail to reconstruct a full analysis hierarchy.
For the primary visual-acuity analysis, the population is limited to participants who completed the 16-week visit within the predefined window of 14 to <20 weeks after randomization. The number included in this analysis is not reported in the registry record. The record does not describe imputation, a missing-data assumption, sensitivity analyses, or how participants without a qualifying visit were handled. It therefore does not establish whether the primary analysis included all randomized participants or how incomplete follow-up affected the estimated result.
The analysis is described as adjusted for baseline age and visual acuity. Additional model details and any further analysis-population definitions are not reported in the registry record. These gaps matter because the population analyzed, the handling of missing observations, and the treatment of multiple outcomes all shape how an estimate should be interpreted. The primary numerical results are not reported in the registry record, so neither their statistical precision nor their relationship to secondary findings can be assessed.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Binocular Treatment Younger | 0 | 190 | 0.0% |
| Patching Treatment Younger | 0 | 195 | 0.0% |
| Binocular Treatment Older | 0 | 40 | 0.0% |
| Patching Treatment Older | 0 | 60 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Binocular Treatment Younger | 0 of 190 |
| Patching Treatment Younger | 0 of 195 |
| Binocular Treatment Older | 0 of 40 |
| Patching Treatment Older | 0 of 60 |
The registry lists four groups: Binocular Treatment Younger, Patching Treatment Younger, Binocular Treatment Older, and Patching Treatment Older. The listed numbers at risk are 190, 195, 40, and 60, respectively. For each group, the record lists 0 participants with a serious adverse event and 0 with an other adverse event. These are the posted counts; they should be read as registry entries for the groups and not as proof that adverse events are impossible or that the treatments have equivalent safety.
The number of deaths is not reported in the registry record. The record also lists no serious adverse-event terms among its top serious terms. A zero count is a descriptive observation, and interpretation depends on the population included, the period of observation, event definitions, and completeness of reporting. Further details about event ascertainment and follow-up are not reported in the registry record.
These safety figures are separate from the primary visual-acuity endpoint. They do not provide evidence about the size or precision of the treatment difference in visual acuity, and they should not be used as a substitute for the primary outcome results. The primary numerical results are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The record establishes the intended comparison: randomized groups receiving binocular computer-game play or patching, with the primary question focused on change in distance visual acuity in children ages 5 to <13 from baseline to 16 weeks. It specifies the acuity protocols, the logMAR-line scale, the direction of improvement, and adjustment for baseline age and visual acuity. These details define what the trial sought to estimate and provide a basis for understanding the endpoint.
However, the primary outcome’s numerical results are not reported in the registry record. There is no posted group mean change, treatment contrast, confidence interval, or p-value in the information described for this account. As a result, the size, direction, and precision of the observed primary comparison cannot be stated. The posted record does not support a conclusion that one treatment produced greater visual-acuity improvement, that the groups were similar, or that either approach was effective or ineffective.
The registry also lists outcomes related to improvement thresholds, resolution of amblyopia, timing of change, age-cohort subgroups, and stereoacuity. Their presence indicates that the study considered more than one dimension of outcome, but their results are not reported in the registry record. The listing of secondary measures does not tell the reader whether a finding was prespecified, statistically persuasive, or consistent with the primary endpoint.
The safety entries report 0 serious adverse events and 0 other adverse events in each listed group, while death counts are not reported in the registry record. These entries describe the registry’s safety data but cannot establish equivalent risks or rule out events beyond the recorded information. Interpretation also depends on the analysis population and follow-up, details that are not fully reported.
In short, the registry information supports a precise description of the research question and some analysis features, but not a conclusion about the comparative results. Any assessment of effect size, uncertainty, statistical significance, or clinical importance requires the numerical outcome results and additional analysis details not reported in the registry record.
13. Why This Trial Matters Statistically
This trial is statistically notable for framing a direct randomized comparison around a continuous, protocol-defined visual-acuity endpoint. A mean change in logMAR lines can retain information about the amount of acuity change, while the separately listed threshold outcomes address whether participants crossed defined improvement or resolution criteria. These answer related but not identical questions, and they should not be treated as interchangeable measures.
The record also distinguishes the younger-cohort primary endpoint from outcomes involving younger and older cohorts and other visual measures. That structure makes the target population and outcome important when interpreting any eventual estimate. A result for the primary younger cohort would not automatically describe every child covered by the broader study description. The record does not report the older cohort’s age definition in the registry record.
Several statistical features are explicit: randomization, a parallel-group design, a 16-week endpoint, a defined visit window, a mean with a 95% confidence interval, and adjustment for baseline age and visual acuity. Those details help frame how an estimate would be read. At the same time, the listed 28 outcome measures and 40 analyses make it important to understand the prespecified analysis hierarchy and multiplicity handling, neither of which is reported in the registry record.
The case also illustrates why an endpoint definition is not a result. Even a clearly described measure cannot reveal the observed treatment contrast without estimates and uncertainty. The primary numerical findings are not reported in the registry record, so the trial’s comparative effect and precision cannot be evaluated from the posted information. Its statistical value in this account lies in clarifying the intended comparison and the information needed for a complete interpretation, rather than establishing a treatment conclusion.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most important limitation for interpretation is that numerical results for the primary endpoint are not reported in the registry record. The record therefore does not provide the group mean changes, adjusted contrast, confidence interval, or p-value needed to assess magnitude, direction, precision, or statistical compatibility with a range of effects.
The analysis population is defined by completing the 16-week visit within the window of 14 to <20 weeks after randomization, but the number of participants meeting that criterion is not reported. The handling of missing or out-of-window data, the use of any imputation, and sensitivity analyses are also not reported. Consequently, the extent to which incomplete follow-up could influence the result cannot be assessed.
The registry identifies adjustment for baseline age and visual acuity but does not report the model specification or other analysis details. Allocation concealment, the identity of the masked party, adherence to the assigned schedules, and details of treatment exposure are not reported in the registry record. The intervention descriptions specify intended schedules, but the record does not establish how consistently participants followed them.
The registry lists numerous outcomes and analyses, while a multiplicity strategy and full analysis hierarchy are not reported. This limits evaluation of how secondary findings should be prioritized relative to the primary endpoint. Safety entries show zero recorded serious and other adverse events in each group, but death counts and further event-ascertainment details are not reported. Finally, the trial’s own sample-size justification is not reported; the listed planning illustration is characterized as separate from the trial’s design. These limits concern what can be inferred from the registry information and do not imply that unreported procedures or results did not exist.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of Binocular Computer Activities for Treatment of Amblyopia — NCT02200211.
- Registry record last updated 2019-02-27; status last verified 2019-02.
- Results first posted 2018-10-15.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes a completed randomized, single-masked, parallel-group study sponsored by Jaeb Center for Health Research, with enrollment of 485. It compares binocular computer-game play on an iPad® with patching in children with amblyopia. The listed study start date is 2014-09-11 and the primary completion date is 2016-08-19.
The primary endpoint is change in distance visual acuity from baseline to 16 weeks in the younger cohort, ages 5 to <13. The measure is expressed in logMAR lines, summarized as a mean with a 95% confidence interval, and adjusted for baseline age and visual acuity. The analysis is limited to participants completing the visit within the stated window.
The record lists additional acuity, amblyopia-resolution, time-course, subgroup, and stereoacuity outcomes. Numerical primary results, multiplicity procedures, missing-data methods, and the trial’s sample-size justification are not reported in the registry record. Safety entries list zero serious and zero other adverse events in each group; death counts are not reported.