DEXTENZA in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for DEXTENZA in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia (NCT05620901), a randomized early/phase 1 study. The primary outcome is Pain as Measured by the FLACC Pain Scale.

2. Clinical Question

In statistical terms, the comparison concerns two postoperative care strategies in a pediatric surgical setting: an intraoperative sustained-release insert and a planned course of topical steroid drops. The study is listed as randomized and parallel, with no masking. Random allocation can support a fair comparison when it is implemented and analyzed appropriately, but the record does not describe the allocation procedure or provide outcome estimates needed to interpret the comparison.

3. Trial Design

The registry describes TENDER as a prospective, open-label, single-center, randomized, investigator-initiated clinical study. It is listed as early phase 1, with a parallel design and no masking. The enrollment is 15. The record lists the study status as completed, with a start date of 2023-02-01 and primary completion on 2025-02-11. These registry entries describe the study’s design and timeline; they do not substitute for outcome results.

Participants were assigned to a Dextenza Arm or a Control Arm (Steroid Drops). The Dextenza arm is described as receiving the insert intraoperatively, with no topical steroid drops prescribed post-operatively. The control arm is described as receiving prednisolone forte 1% drops on a tapering schedule lasting 28 days. A secondary outcome counts treatment participants who were given supplementary prednisolone drops, so the intervention description does not rule out that such drops could be recorded as an outcome.

The study’s primary outcome is pain as measured by the FLACC scale. Measurements are scheduled at baseline and post-op days 1, 7, 28, and 45. The record also lists outcomes concerning adverse events, anterior chamber inflammation, pain resolution, intraocular pressure, rebound inflammation, and supplementary drops. It lists 12 outcome measures and 15 analyses, but does not give a detailed statistical analysis plan for those analyses.

Although randomization is specified, details about sequence generation, allocation concealment, stratification, and implementation are not reported in the registry record. The record also does not describe the enrolled participants’ age distribution, the number screened or excluded, or the populations used in the analyses. The study’s single-center setting and open-label design are relevant to how results would be interpreted, while the absence of reported primary outcome values prevents a comparison of efficacy estimates.

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

Reasons for not completing this period:

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.

6. Primary Endpoint

The registry lists the primary outcome as Pain as Measured by the FLACC Pain Scale, measured over Baseline, post-op days 1, 7, 28, and 45.

The primary outcome is pain measured by the Face, Legs, Activity, Cry and Consolability (FLACC) scale. The registry describes it as an observational scale comprising five behavioral indicators, each scored from zero to two. The total score ranges from zero to 10. Lower scores indicate minimal to no pain, while high scores indicate moderate to severe discomfort.

The scheduled assessments are baseline and post-op days 1, 7, 28, and 45. Repeated measurements can describe pain at more than one stage of recovery rather than relying on a single observation. Baseline measurement can also give context for interpreting post-operative scores, although the registry record does not state how baseline values were incorporated into the analysis.

The registry identifies the measure as a median with standard deviation. A median describes the middle of an ordered set of scores; standard deviation describes spread around a mean and is not, by itself, a direct measure of uncertainty in the median. The analysis method and rationale for pairing these summaries are not reported in the registry record. No FLACC values, between-arm estimates, confidence intervals, or p-values are reported, so the magnitude and precision of any difference cannot be assessed from this record.

FLACC is an observational measure rather than a direct self-report. That makes clear scoring procedures and consistent assessment important, especially in an open-label study. Further details on assessor training, masking of assessors, and handling of assessments that could not be completed are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Randomization assigns participants to study groups using a chance-based process. In general, its purpose is to reduce systematic differences between groups at the time of assignment, so that later outcome comparisons can be interpreted as comparisons of assigned strategies. The record says the study was randomized and parallel, but does not report how the random sequence was generated, whether assignment was concealed, or whether any stratification was used. Those implementation details are important for evaluating how randomization operated in practice.

What does an open-label design imply?

Open-label means that treatment assignment was not masked. The registry lists masking as none. In general, awareness of the assigned approach can affect participant expectations, clinical decisions, and outcome measurement. These possibilities are particularly relevant when an outcome is based on behavioral observation. The record does not state whether FLACC assessors were separately masked, or whether standardized procedures were used to limit assessment differences between arms.

How should repeated FLACC measurements be understood?

The outcome schedule includes baseline and post-op days 1, 7, 28, and 45. Measurements from the same participant are related: a person’s score at one assessment is not necessarily statistically independent of that person’s score at another. General methods for repeated outcomes account for that within-participant relationship, or specify a particular time point as the main comparison. The registry record does not report which approach was used, whether the primary contrast was at one time point or across time, or how baseline scores were handled.

The registry names the summary as a median with standard deviation. The median is a measure of central location that is less affected by unusually high or low observations than the mean. Standard deviation describes dispersion around the mean, so it is not a conventional direct measure of uncertainty around a median. Other summaries or analysis methods may be suitable depending on the distribution and analysis objective, but the selected method and its justification are not reported in the registry record. No numeric FLACC summaries are reported for interpretation.

Why can over-dispersion matter?

General count-data methods often assume a particular relationship between the mean and variability of the counts. Over-dispersion means that the observed variability is greater than that assumed by a model. If it is ignored, uncertainty estimates can be too small and statistical tests can be misleading. The record lists outcomes that include numbers of participants with events, but does not describe a count-data model or report evidence of over-dispersion. This general issue should not be read as a claim that over-dispersion occurred in this study.

What do confidence intervals and p-values contribute?

In general, a confidence interval expresses the uncertainty around an estimated effect under the assumptions of the analysis. Its width helps readers judge precision, while its position describes which effect values are compatible with the data and method. A p-value evaluates how compatible the observed data are with a specified null model; it does not measure the probability that a treatment effect is true. Neither an estimate nor an interval nor a p-value for the primary outcome is reported in the registry record, so these inferential features cannot be evaluated.

The record lists 12 outcome measures and 15 analyses. Multiple outcomes, time points, or analyses can create multiplicity: the more comparisons considered, the greater the chance that at least one result may look notable by chance if no adjustment or prespecified hierarchy is used. Whether adjustment was planned, which outcome comparisons were primary, and how the listed analyses relate to the outcomes are not reported in the registry record. The number of listed analyses alone does not establish that a particular multiplicity problem occurred.

How should planning illustrations be read?

A sample-size calculation is a planning tool, not a result from participants. The described illustration uses a two-sided significance level of 0.05, equal allocation, and a normal approximation; its target effect is expressed as a stated fraction of the observed effect. Such assumptions describe a hypothetical calculation and do not establish what the trial was designed or powered to detect. In particular, a planning illustration based on an observed effect is not observed power. Numerical planning outputs are not reported in the registry record, and the trial’s own sample-size justification is not reported.

Finally, statistical interpretation depends on the analysis population and the handling of incomplete data. An intention-to-treat analysis generally compares participants according to their randomized assignment; other analysis populations can answer different questions and may be more vulnerable to bias. These are general distinctions, not a description of the method used in TENDER. The registry record does not report the analysis population, the amount or pattern of missing data, or the method used to address missing measurements.

10. Multiplicity, Missing Data and Analysis Populations

The study has several scheduled primary-outcome assessments: baseline and post-op days 1, 7, 28, and 45. It also lists secondary outcomes covering adverse events, anterior chamber cell count and presence, pain resolution, absolute intraocular pressure change, rebound inflammation, and supplementary prednisolone drops. The registry lists 12 outcome measures and 15 analyses. When multiple outcomes or time-point comparisons are examined, general statistical practice considers whether a hierarchy or multiplicity adjustment was prespecified, because repeated testing can increase the chance of apparently notable findings.

That concern cannot be resolved from the registry description alone. The statistical analysis plan, the intended primary contrast across time, and any procedure to control multiplicity are not reported in the registry record. The record also does not provide results for the listed secondary outcomes, so the number of positive, null, or inconclusive findings cannot be assessed.

The record does not report how missing measurements, withdrawals, or protocol deviations were handled. Missingness can affect both the estimate and its uncertainty, particularly when the likelihood of a missing observation is related to the participant’s outcome or assigned approach. The record does not state whether all randomized participants were included in each analysis, whether analysis populations differed by outcome, or whether any sensitivity analyses were conducted.

These omissions do not establish that the trial lacked a prespecified plan or that data were missing. They mean only that the registry record does not report the information needed to assess these features. Without that information, it is not possible to judge whether outcome selection, missingness, or analysis-population choices could have influenced the reported estimates.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The registry safety groups list 11 participants at risk in the Dextenza Arm and 4 in the Control Arm (Steroid Drops). For each group, the record lists zero participants with serious adverse events, zero with other adverse events, and zero deaths. These are the recorded safety counts for the groups as listed.

Zero reported events should be interpreted within the scope of this record. It does not mean that the risk of an event is known to be zero, nor does it establish that the two strategies have identical safety profiles. With small groups, uncommon events may not be observed, and the absence of a recorded event does not provide a precise estimate of how often such an event might occur in a broader population. No confidence intervals or additional safety analyses are reported in the registry record.

The record lists “Number of Participants With Adverse Events” and “Severity of Adverse Events” among secondary outcomes, but detailed findings for those outcomes are not reported. The listed zero counts therefore should not be extended to outcomes, event definitions, or follow-up information that are not described. Serious events, other events, and deaths are distinct categories in the safety listing; their recorded counts do not provide information about the primary FLACC outcome.

12. What the Result Does, and Does Not, Mean

The registry record describes a randomized comparison of an intraoperative DEXTENZA insert with a postoperative Pred Forte drop taper in pediatric patients following retinal surgery or laser treatment under anesthesia. It specifies pain measured by FLACC at baseline and post-op days 1, 7, 28, and 45 as the primary outcome. These registry entries identify the question the study was intended to address; they do not show the answer.

The primary outcome values and comparative estimates are not reported in the registry record. Readers therefore cannot determine the direction or magnitude of any difference in pain scores, the pattern across scheduled assessments, or the precision of a comparison. No statistical significance claim can be evaluated without reported estimates and uncertainty information. The completed status is not a substitute for those findings.

The safety listing records zero serious adverse events, zero other adverse events, and zero deaths in each group, with 11 and 4 participants at risk in the respective arms. Those entries describe the recorded counts, not proof that an approach has no risk. They also cannot answer the question about pain scores or establish a comprehensive comparison of safety.

More broadly, a small, open-label, single-center randomized study can contribute information, but its interpretation depends on outcome reporting, precision, implementation of randomization, completeness of follow-up, and analysis choices. Several of these details and the outcome estimates are not reported in the registry record. The record alone consequently cannot support a conclusion about the comparative efficacy or overall safety of the two postoperative approaches.

This distinction is statistical rather than clinical advice. The registry record identifies treatments and outcomes, while the absence of reported comparative results limits what can be inferred from it. It should not be read as evidence either for or against a difference.

13. Why This Trial Matters Statistically

This study raises a statistical question in a specific setting: how to compare a sustained-release insert placed during retinal surgery or laser treatment with a prescribed topical steroid taper afterward. Random allocation is relevant because it can help create comparable groups, while the open-label design and observational primary outcome make consistent assessment especially important. These design features shape how any eventual estimates should be interpreted.

The primary measure is collected repeatedly, from baseline through post-op day 45. Repeated observations can characterize the course of pain rather than a single snapshot, but they require a clear analysis strategy. A reader needs to know which time point or summary defines the primary comparison, how the within-participant relationship is handled, and whether baseline is incorporated. These details are not reported in the registry record.

The study also lists a broad set of secondary outcomes, including inflammation, intraocular pressure, pain resolution, rebound inflammation, adverse events, and supplementary drops. Such outcomes may describe different dimensions of postoperative care, but multiple endpoints make prespecification and transparent reporting important. The record lists 12 outcome measures and 15 analyses without reporting the detailed analysis plan or the findings for these outcomes.

The modest enrollment of 15 and the listed safety group sizes of 11 and 4 make precision an important consideration. Estimates from small groups can be uncertain, so point estimates alone would not be enough; confidence intervals and clear reporting of missing observations would help readers judge what range of effects remains compatible with the data. Those primary outcome estimates and uncertainty measures are not reported in the registry record.

For statistical education, the central lesson is that a design description and a results record answer different questions. This record makes the intended comparison and measurement schedule visible, but it does not report the results required to quantify the primary contrast. Clear outcome estimates, uncertainty, analysis populations, missing-data handling, and multiplicity decisions would be needed for a fuller statistical interpretation.

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 contains limited information for evaluating the study’s implementation and findings. It identifies a randomized, open-label, single-center design and enrollment of 15, but does not report how the random sequence was generated, how allocation was concealed, or whether allocation was stratified. Details on participant age distribution, eligibility criteria beyond the described population and conditions, screening, exclusions, and baseline characteristics are also not reported in the registry record.

The central limitation for interpreting efficacy is that FLACC results are not reported. There are no arm-specific values at the scheduled assessments, no comparative effect estimate, and no uncertainty measure. The analysis approach for repeated measurements and the rationale for summarizing a median with standard deviation are not reported. Without those details and data, the primary outcome cannot be independently assessed from the registry record.

The record does not report the number of missing assessments, withdrawals, protocol deviations, or analysis populations. It does not describe assessor training or whether assessors were masked despite the open-label design. These are relevant considerations for an observational outcome. The detailed statistical plan, including any multiplicity strategy for the listed outcomes and analyses, is also not reported.

The safety counts are limited to the listed groups and categories. Definitions, event timing, follow-up completeness, and detailed results for adverse-event severity are not reported in the registry record. The study’s single-center setting and enrollment of 15 also constrain how broadly any eventual estimates could be generalized, although the degree of that limitation depends on participant and site characteristics not reported.

These are limits on interpretation of the registry record, not proof that the study did not collect additional information. The record lists completed status, but does not provide the primary outcome results needed to assess the comparative effect.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: DEXTENZA in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia — NCT05620901.
• Registry record last updated 2026-04-23; status last verified 2026-02.
• Results first posted 2026-04-23.
• 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.

18. Record Summary

NCT05620901 is listed as a completed, randomized, open-label, parallel, early-phase 1 study with enrollment of 15. The registry describes TENDER as a prospective, single-center, investigator-initiated study of pediatric patients following retinal surgery or laser treatment under anesthesia. The intervention is an intraoperative DEXTENZA insert; the comparator is a post-operative Pred Forte taper over 28 days.

The primary outcome is pain measured with the FLACC scale at baseline and post-op days 1, 7, 28, and 45. The record lists 12 outcome measures and 15 analyses, but does not report the primary pain results, comparative estimates, confidence intervals, or p-values. It lists zero serious adverse events, zero other adverse events, and zero deaths in both safety groups, with 11 participants at risk in the Dextenza Arm and 4 in the Control Arm. Important analysis details, including missing-data handling and analysis populations, are not reported in the registry record.