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 Evaluation of a Program to Enhance Ophthalmic Compliance in Children and Adolescents With Special Needs (NCT06717282), a na na study. The primary outcome is Visual Function Battery for Children With Special Needs (VFB-CSN).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06717282 |
| Phase | NA |
| Condition | Visual Rehabilitation, Visual Impairment, Autism Spectrum Disorder, Developmental Disabilities, Intellectual Disability, Behavioral Symptoms |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 20 |
| Arms in the primary outcome | n/a |
| Lead sponsor | National Taiwan University Hospital |
| Results posted | Yes |
2. Clinical Question
Population
Children and adolescents with special needs, including conditions listed in the registry such as visual impairment, autism spectrum disorder, developmental disabilities, intellectual disability, and behavioral symptoms. The primary outcome analysis included 14 participants because pre- and/or post-intervention data were incomplete for 6 participants.
Intervention
A structured program using contextual, behavioral, and cognitive strategies to support cooperation during ophthalmic examinations. Participants were to attend six individualized training sessions, one session every two weeks, with each session lasting one hour.
Comparator
There was no separate control group. The study used a single-group design, with pre-intervention and post-intervention assessments. The registry lists allocation as not applicable and masking as none, so the design does not provide a randomized, like-for-like comparison between groups.
Primary question
Does the structured program increase ophthalmic examination compliance in children and adolescents with special needs? The registered primary outcome is the Visual Function Battery for Children With Special Needs (VFB-CSN), a measure of visual function. The registry also lists the Ophthalmic Visit Adaptation Questionnaire as a secondary outcome. It does not report numerical results for either measure, so the record does not establish the size or direction of any pre-to-post change.
The study addresses a practical measurement challenge: ophthalmic examinations can involve multiple tasks, and the registry describes a program designed to help participants practice cooperation in specialized or general ophthalmic settings. The clinical question is framed around compliance, while the named primary endpoint assesses visual function. These are related in the study’s stated rationale, but they are not identical constructs. The registry does not report a separate numerical compliance result or explain how the primary score was intended to represent compliance. That distinction matters when interpreting what the outcome can answer.
3. Trial Design
The registry describes a completed, single-group behavioral study sponsored by National Taiwan University Hospital. Enrollment was 20. The listed study start date is 2024-12-15, and the primary completion date is 2026-01-21. The study is marked completed. Its phase and allocation are listed as not applicable, and masking is listed as none.
Participants were to take part in six individualized training sessions. The brief summary describes one session every two weeks, lasting one hour, with activities intended to practice and enhance cooperation during ophthalmic examinations. Assessments were planned before and after the program, including measurement of visual function, behavioral adaptation, and other intervention outcomes. The primary endpoint timeframe is pre-intervention and post-intervention within 6 months. The registry does not give further detail about the timing of each assessment relative to the sessions.
Because the study has one group and no listed control condition, its central comparison is within participants over time, rather than between participants assigned to different interventions. Such a design can describe observed change in the participants with data at both assessments. By itself, it cannot distinguish an intervention-associated change from changes that might occur over time or from other influences. The registry does not report a randomized allocation process or a masking procedure.
The outcome analysis included 14 participants. The registry attributes the smaller analysis population to incomplete pre- and/or post-intervention data for 6 participants. It does not report further details on recruitment, participant characteristics, adherence to the sessions, reasons for incomplete assessments, or whether any participants discontinued the program. Those omissions limit assessment of how well the analyzed participants represent the full enrolled group and how the program was delivered in practice.
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 | Experimental: Intervention to Improve Ophthalmic Compliance |
|---|---|
| STARTED | 20 |
| COMPLETED | 20 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Fourteen participants (N = 14) were included in the outcome analysis due to incomplete pre- and/or post-intervention data in 6 participants.
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.
Population: Baseline characteristics were collected for all enrolled participants (N = 20).
| Characteristic | Unit | Experimental : Intervention to Improve Ophthalmic Compliance |
|---|---|---|
| Participants analysed | 20 | |
| Age, Continuous | Years | 6.82 (SD 2.64) |
| Sex: Female, Male: Female | Participants | 8 |
| Sex: Female, Male: Male | Participants | 12 |
| Race and Ethnicity Not Collected | Participants | — |
6. Primary Endpoint
The registry lists the primary outcome as Visual Function Battery for Children With Special Needs (VFB-CSN), measured over Pre-intervention and post-intervention (within 6 months).
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Standard Deviation |
| Unit | score |
| Endpoint classification | not reduced to a single comparison |
The registered primary endpoint is the Visual Function Battery for Children With Special Needs (VFB-CSN). It is described as a standardized measure covering visual reflex, ocular muscle balance, visual acuity, oculomotor function, visual field, contrast sensitivity, colour/form vision, and visual attention. Its total score ranges from 0 to 60, with higher scores indicating better visual function. The registry specifies the score as a median with standard deviation and sets the timeframe at pre-intervention and post-intervention within 6 months.
A broad battery can represent several aspects of visual function in a population for whom assessment may involve multiple domains. Repeated assessment can describe whether measured scores differ after participation in a program. However, the endpoint is a visual-function score, not a direct count or rate of ophthalmic examination compliance. The registry does not explain the relationship between change in this score and the program’s stated goal of improving cooperation during examinations, nor does it report a separate primary compliance measure.
No median values, standard deviations, pre-to-post estimates, or uncertainty intervals are reported in the registry record. Consequently, the endpoint’s measurement properties and scoring range can be described, but the observed result and its precision cannot be evaluated from the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies the study as completed and reports enrollment of 20 participants. For the primary outcome analysis, 14 participants were included because pre- and/or post-intervention data were incomplete in 6 participants. These numbers describe enrollment and availability of outcome data; they do not reveal whether the VFB-CSN score increased, decreased, or remained similar. The registry record does not report the primary outcome values or a numerical estimate of change.
The stated question concerns whether a structured program increases ophthalmic examination compliance. The study’s named primary endpoint is the VFB-CSN, which measures visual function. The registry also names the Ophthalmic Visit Adaptation Questionnaire as a secondary outcome. It does not report numerical findings for either outcome, or explain how either measure was used to quantify compliance. Thus, the record does not allow readers to judge the magnitude, direction, or precision of change in the targeted behavior or in visual function.
The single-group pre-intervention and post-intervention design has no concurrent control group. A change observed in such a design would describe what happened among participants with available assessments, but would not, on its own, establish that the program caused the change. Without a control group, other influences over time cannot be separated from an intervention-associated pattern. This is a design limitation, not evidence that a change did or did not occur.
Precision also cannot be assessed from the registry record because it provides no outcome estimates, confidence intervals, or p-values. A confidence interval, as a general statistical concept, describes a range of values compatible with an estimate under the analysis assumptions; it helps readers distinguish a precise estimate from one with substantial uncertainty. No such interval is reported for the primary or secondary outcome.
The registry’s description of the primary score as a median with standard deviation warrants attention when results are eventually interpreted. As a general statistical point, the median describes the middle of an ordered distribution, while standard deviation conventionally describes variation around the mean. The pairing does not by itself establish that the analysis is invalid, but the registry does not explain the rationale or specify how the score was analyzed. Without the observed values and analysis details, readers cannot assess the distribution or determine whether the summary is appropriate.
Accordingly, the registry supports a description of the study question, program, and outcome-analysis population, but not a conclusion about the program’s observed effect. No claim about benefit or lack of benefit follows from absent numerical results.
9. Statistical Methods Explained
Interpreting a clinical study requires separating the design, the measured outcome, the analysis population, and the uncertainty around results. The registry record describes these elements unevenly. It gives the single-group design, the planned program, the primary measure, and the number included in the primary outcome analysis, but it does not report numerical outcome findings or a detailed statistical analysis plan.
What does a single-group design compare?
In a single-group pre-intervention and post-intervention design, the same group is assessed at different times. The comparison is within participants, rather than between an intervention group and a concurrent control group. This can describe change over the observation period among those with measured outcomes. In general, however, a before-and-after pattern does not isolate the effect of the program: changes over time, repeated measurement, or other influences may contribute. A concurrent comparison group can help address some of these alternative explanations, but none is listed in this study.
Here, the registry lists allocation as not applicable, masking as none, and the model as single group. It does not report a randomized comparison. The design therefore cannot support a randomized treatment contrast. The registry also does not describe blinded outcome assessment, so the potential role of assessor knowledge in measurement cannot be evaluated.
What does the primary score represent?
The VFB-CSN is described as a standardized measure of multiple visual-function domains. Its total score ranges from 0 to 60, and higher scores indicate better visual function. The listed endpoint is a median with standard deviation at pre-intervention and post-intervention within 6 months. This identifies the intended summary and assessment period, but not the statistical test, model, or estimand used to compare assessments. An estimand is the precise quantity an analysis aims to describe, such as change in a defined population over a specified period. The registry does not state that quantity in more detail.
As a general statistical concept, the median is useful for describing the center of ordered data and is less influenced by extreme observations than the mean. Standard deviation describes spread around the mean under conventional use. For skewed data, other spread summaries may be more aligned with the median, but the registry does not provide score distributions or explain its choice of summary. It is therefore not possible to assess the distribution, assumptions, or suitability of the reported summary approach.
How should uncertainty be understood?
An estimate describes the observed pattern in a sample, while a confidence interval communicates uncertainty around that estimate under stated assumptions. A p-value, when reported, addresses compatibility of data with a specified statistical model and null hypothesis; it is not a measure of effect size or clinical importance. The registry record reports no outcome estimates, confidence intervals, or p-values. Statistical significance and precision therefore cannot be evaluated.
The sample-size assumptions describe planning illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. These are planning assumptions, not evidence that the trial itself used a two-arm design: the registered study is single group. The planning illustrations are not observed power. The registry does not report a sample-size justification for the actual study or enough detail to reconstruct a design-specific calculation. Since outcome estimates are not reported in the record, the numerical planning implications cannot be interpreted from it.
Why can over-dispersion matter?
As a general statistical concept, over-dispersion occurs when observed variability is greater than a model assumes. If a model does not account for that extra variability, standard errors and uncertainty intervals can be misleading. This issue is especially relevant to outcome types whose variability is constrained by their scale or distribution. The registry does not report a model for the VFB-CSN score, an over-dispersion assessment, or any model diagnostics. It is not possible to say whether over-dispersion was relevant or how it was handled in this study.
What can the record establish?
The registry establishes that 20 participants were enrolled and that 14 were included in the primary outcome analysis because pre- and/or post-intervention data were incomplete for 6 participants. It lists two outcome measures and two analyses, but does not describe the relationship between the analyses and outcomes in enough detail to infer which statistical procedure was used. No analysis population beyond the stated primary-outcome group, adjustment strategy, or handling of repeated measurements is reported. These details matter because analytical choices affect what an estimate means and how uncertainty should be interpreted. In their absence, interpretation should remain descriptive and limited to the registry’s stated design and population counts.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures: the VFB-CSN as the primary outcome and the Ophthalmic Visit Adaptation Questionnaire as a secondary outcome. It also reports two analyses. It does not describe the analysis methods or state whether the two analyses correspond directly to the two outcomes. The record does not report whether there were additional comparisons, domains, time points, or subgroup analyses.
Multiplicity arises when several outcomes or statistical comparisons are examined. As a general statistical concept, looking at multiple results can increase the chance of finding an apparently unusual result even when no underlying effect exists. A prespecified hierarchy or adjustment method can help clarify how multiple tests are interpreted. The registry record does not report a multiplicity strategy, so it is not possible to determine whether or how the analyses accounted for multiple outcomes or comparisons.
For the primary outcome, 14 participants were included because pre- and/or post-intervention data were incomplete in 6 participants. The record does not explain why data were incomplete, whether missingness occurred at one assessment or both, or whether the reasons were related to participant characteristics or outcomes. It does not report imputation, sensitivity analyses, or other methods for handling missing data. The effect of the incomplete data on the reported analysis therefore cannot be assessed.
The registry does not define an intention-to-treat or per-protocol analysis population. The only clearly stated population is the 14 participants included in the primary outcome analysis. It is not reported whether all enrolled participants began or completed the program, or whether questionnaire analyses used the same participants. These omissions limit interpretation of the analysis population and the generalizability of any eventual estimate.
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 |
|---|---|---|---|
| Experimental: Intervention to Improve Ophthalmic Compliance | 0 | 20 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Experimental: Intervention to Improve Ophthalmic Compliance | 0 of 20 |
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 |
|---|---|
| Experimental: Intervention to Improve Ophthalmic Compliance | 0 of 20 |
The registry reports 20 participants at risk in the intervention group and 0 participants with serious adverse events. It also reports 0 participants with other adverse events and 0 deaths. No serious adverse-event terms are listed.
These figures describe the events recorded in the registry for the listed group. They do not establish that no adverse events of any kind occurred, because the record’s categories and reporting details may not capture every event, and no further safety definitions or assessment period are provided. The registry does not report how events were collected, how severity or relatedness was judged, or whether reporting covered the entire period from enrollment through follow-up.
The figures should therefore be read narrowly: no serious adverse events, other adverse events, or deaths are reported among the 20 participants in the listed group. They do not provide a comparison with another group, since the design is single group, and they do not quantify risk beyond the reported counts.
12. What the Result Does, and Does Not, Mean
The registry record describes a completed study of a structured program intended to support ophthalmic examination compliance in children and adolescents with special needs. It specifies six individualized sessions and pre-intervention and post-intervention assessments. It also identifies a primary visual-function measure and a secondary visit-adaptation questionnaire. This information clarifies the intervention’s aim and the outcomes selected for assessment.
The record does not report the measured outcome values. It therefore does not show whether scores changed, the size or direction of any change, or how precise an estimate might be. It also does not report a numerical compliance result. The study’s stated question about increasing examination compliance cannot be answered from the registry information available for these outcomes.
Even if a pre-to-post change were reported, the single-group design would require cautious interpretation. Without a control group, such a change would not establish that the program caused it. Other influences over time could contribute to an observed pattern. The absence of masking, as listed in the registry, is another design feature relevant to interpretation, though the record does not describe who assessed outcomes or how measurements were conducted.
The primary outcome analysis included 14 participants, while 6 participants had incomplete pre- and/or post-intervention data. The registry does not explain the missingness or describe analyses to assess its impact. Results from the analyzed participants, if reported elsewhere, would need to be interpreted in light of this incomplete outcome data and the absence of a defined analysis population beyond those included.
In short, the registry supports conclusions about the study’s design, program, endpoint, and analysis count. It does not support a conclusion about whether the program improved compliance or visual function, nor does it establish the size, precision, or cause of any change.
13. Why This Trial Matters Statistically
This study is statistically notable for the distinction between its stated behavioral goal and its registered primary endpoint. The program aims to improve cooperation during ophthalmic examinations, while the VFB-CSN measures visual function across several domains. The registry also names a questionnaire about adaptation to ophthalmic visits. Clear interpretation depends on knowing which construct each outcome measures and how the outcomes relate to the main question. The record does not explain that relationship in detail.
The single-group pre-intervention and post-intervention design is another important feature. It can describe change among participants assessed over time, but does not supply a concurrent control comparison. That distinction affects what causal claims can be made, regardless of whether an observed score change is large or small. The registry reports no outcome estimates, so the observed pattern itself cannot be evaluated.
Incomplete outcome data also matter. Enrollment was 20, while the primary outcome analysis included 14 participants because data were incomplete for 6. Without reasons for missingness or analyses addressing it, readers cannot determine whether the analyzed group adequately represents all enrolled participants. This uncertainty is separate from the uncertainty that would be expressed by a confidence interval around an estimate.
Finally, the registry describes the primary summary as a median with standard deviation but does not provide the underlying values, distribution, or analysis method. These details would help readers assess how the score was summarized and compared over time. The record’s planning assumptions are not a substitute for the trial’s analysis plan or outcome results. Together, these features make transparent reporting of endpoint values, missing-data handling, and analysis methods especially important for understanding the study.
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 registry record leaves several trial-specific limitations unresolved. It does not report participant characteristics beyond the population description, so the composition of the enrolled group and the range of needs represented cannot be assessed. The listed conditions span visual impairment, autism spectrum disorder, developmental disabilities, intellectual disability, and behavioral symptoms, but no counts or subgroup descriptions are reported.
The intervention is described in broad terms as contextual, behavioral, and cognitive-based strategies, with six individualized sessions. The registry does not provide further detail on session content, how the program was delivered, whether delivery was consistent across participants, or participant attendance and engagement. It also does not report the timing of individual assessments beyond the primary endpoint timeframe of pre-intervention and post-intervention within 6 months.
The primary outcome is a visual-function battery, while the trial question emphasizes ophthalmic examination compliance. The record does not explain how the score relates to compliance, report a separate numerical compliance endpoint, or provide results for the secondary questionnaire. This makes it difficult to judge how directly the registered outcomes address the stated question.
The design has no separate control group, and masking is listed as none. The record does not describe who administered or scored the assessments. It also does not report outcome estimates, statistical methods, confidence intervals, p-values, or a detailed missing-data approach. Six participants had incomplete pre- and/or post-intervention data, but the reasons and their potential influence are not reported. These gaps prevent evaluation of the magnitude and precision of change, the analysis assumptions, and the possible impact of missing outcomes.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation of a Program to Enhance Ophthalmic Compliance in Children and Adolescents With Special Needs — NCT06717282.
- Registry record last updated 2026-03-13; status last verified 2026-01.
- Results first posted 2026-03-13.
- 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
NCT06717282 is a completed, single-group behavioral study sponsored by National Taiwan University Hospital. It enrolled 20 participants and evaluated a structured program intended to improve ophthalmic examination compliance in children and adolescents with special needs. The program comprised six individualized training sessions, one every two weeks, each lasting one hour.
The primary outcome was the VFB-CSN, a visual-function score measured before and after the intervention within 6 months. The secondary outcome was the Ophthalmic Visit Adaptation Questionnaire. Fourteen participants were included in the primary outcome analysis because pre- and/or post-intervention data were incomplete for 6 participants. The registry reports no numerical outcome results or detailed statistical analysis methods. It lists 0 serious adverse events, 0 other adverse events, and 0 deaths among 20 participants at risk.