AcrySof® Bilateral PanOptix(R) Spectacle Freedom and Patient Satisfaction Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for AcrySof® Bilateral PanOptix(R) Spectacle Freedom and Patient Satisfaction Study (NCT04126187), a registered phase not stated study. The primary outcome is Number of Participants Who Have Spectacle Independence.

2. Clinical Question

The study's stated objective is to assess spectacle independence after participants receive the Panoptix lens. That question is patient-reported: it concerns how often participants say they wear spectacles for different visual tasks, rather than relying only on a visual-acuity measurement. The registry also names binocular uncorrected and corrected visual-acuity measures, spherical equivalent refraction, and residual refractive cylinder as secondary outcomes. Those measurements address visual function and refractive status, but they are distinct from the primary question about reported spectacle use.

The record lists enrollment of 30 and a completed study status. Those details describe the registered study, not the number of participants whose primary endpoint was observed or included in an analysis. The registry does not report that endpoint denominator, participant-level responses, or a comparison group. As a result, the clinical question can be described from the stated objective and endpoint definition, but the posted record does not provide the result needed to answer it.

3. Trial Design

The registry describes a device study of bilateral Panoptix trifocal intraocular lens implantation in participants with cataract. Its stated objective is to assess spectacle independence after uneventful cataract surgery. The record lists 30 participants as the enrollment, identifies Gainesville Eye Associates as the sponsor, and marks the study as completed. The recorded start date is 2020-05-14 and the primary completion date is 2021-03-30.

Only the Panoptix intervention and its bilateral implantation arm are described. No comparator arm is listed, and allocation is not stated. The record does not describe a randomized comparison or provide a parallel control group. Findings from this study, if reported, would therefore need to be interpreted as observations from the described group rather than as a direct estimate of a difference between assigned treatments.

The primary outcome is a participant count based on reported spectacle use at 3 months after surgery. The definition classifies participants reporting spectacle use “a little of the time” or “none of the time” for distance, intermediate, or near vision as never or rarely wearing spectacles. The registry also lists secondary outcomes covering binocular visual acuity under uncorrected, best-corrected, or distance-corrected conditions, along with spherical equivalent refraction and residual refractive cylinder. The record identifies 10 outcome measures in total.

The registry does not report additional details about eligibility criteria, recruitment, masking, visit procedures, handling of both eyes, or the statistical analysis plan. It also does not state how many participants completed follow-up or contributed data to each outcome. These omissions limit how fully the conduct and analysis of the study can be reconstructed from the registry record. The completed status indicates the study's recorded status; it does not itself establish that outcome results or a complete analysis were posted.

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

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 Number of Participants Who Have Spectacle Independence, measured over 3 months.

The primary endpoint is the number of participants who have spectacle independence, expressed in the registry description as the percent of patients who never or rarely wear spectacles for distance, intermediate, or near vision at 3 months after surgery. The classification is based on the Patient-Reported Spectacle Independence Questionnaire. The stated qualifying responses are “a little of the time” or “none of the time.”

This endpoint is used to assess the study's stated objective: spectacle independence after bilateral Panoptix implantation. It captures reported use of spectacles across several visual distances, which is not the same thing as a measured visual-acuity score. A patient-reported measure can address an everyday behavior or experience that an acuity test alone may not describe. This is a general reason patient-reported outcomes can be relevant; it does not establish that the endpoint fully represents every aspect of spectacle use or visual function.

The registry record does not report the observed count, percentage, denominator, or participant responses for this endpoint. Enrollment of 30 cannot be substituted for an endpoint denominator, because the record does not say how many participants had an evaluable response at the specified time. Nor does the endpoint definition alone indicate how many participants met the criterion. Without the posted result and its denominator, the endpoint can be interpreted as a prespecified type of patient-reported outcome, but its observed frequency and precision cannot be assessed.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What kind of endpoint is being counted?

The primary endpoint is described as a count of participants meeting a binary criterion: spectacle independence as defined by the questionnaire responses. In general, a binary outcome places each assessed participant into one of two categories, such as meeting or not meeting a stated criterion. Interpreting a count requires knowing both the number in the qualifying category and the number assessed. The registry record defines the qualifying responses and assessment time, but does not report either the observed count or the endpoint denominator.

The registry also describes the outcome as a percentage. In general, a percentage expresses a qualifying count relative to an applicable denominator. It can be useful for understanding frequency when the denominator is clear. The record does not report an observed percentage, so no frequency estimate can be read from the endpoint definition or the enrollment figure alone. The reported enrollment is not a substitute for a documented outcome denominator.

What can a confidence interval tell a reader?

In general, a confidence interval gives a range of values compatible with the observed data under a specified statistical procedure and its assumptions. A narrower interval indicates greater precision under those assumptions; a wider interval indicates more uncertainty. An interval does not establish that a finding is clinically important, correct for bias, or applicable beyond the participants studied. No confidence interval for the primary endpoint is reported in the registry record, so its precision cannot be evaluated from the posted information.

For a binary endpoint, methods for estimating uncertainty depend on the data and analytic choices. General choices may include how the interval is constructed and how the denominator is defined. The registry record does not state the method used for an interval or provide an analysis from which to assess it. Without a reported result and method, a reader should not infer a precision estimate.

Why does the absence of a comparator matter?

The registry lists bilateral Panoptix implantation and does not list a comparator arm. Allocation is not stated. In general, a group observed after receiving an intervention can describe outcomes in that group, but a treatment contrast requires a meaningful comparison. Randomization, when used and adequately conducted, is a design approach intended to make groups comparable on average; the registry record does not describe such a comparison. It would therefore be inappropriate to interpret the record as providing an estimate of a difference between Panoptix and another treatment.

Even a clearly measured within-group frequency can be affected by factors beyond the intervention, including participant selection, follow-up, or how outcome responses are obtained. These are general considerations rather than reported problems in this study. The record does not provide information sufficient to evaluate them.

What do the listed secondary measures add?

The secondary outcomes include binocular uncorrected distance, intermediate, and near visual acuity; binocular best-corrected distance visual acuity; binocular distance-corrected intermediate and near visual acuity; spherical equivalent refraction; and residual refractive cylinder. In general, these outcomes measure aspects of visual acuity or refractive status that differ from questionnaire-reported spectacle use. They can offer complementary descriptions, but they do not replace the primary endpoint or directly answer the same patient-reported question.

The record identifies 10 outcome measures, but it does not report numerical results for these measures or describe their analysis. It also lists no analyses. The named outcomes should therefore be read as registered measurements, not as evidence that a particular result was observed or that a particular statistical test was performed.

What do planning illustrations mean?

In general, a sample-size planning illustration asks how many participants might be needed under specified assumptions to detect a chosen effect with a selected significance level and power. Such an illustration is not an analysis of the enrolled participants and is not observed power. The registry record states assumptions for planning illustrations, including a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also describes the effect to detect as a stated fraction of the observed effect.

Those assumptions do not describe the trial's own design or establish that the study had two arms. The registry lists no comparator arm and does not report the trial's sample-size justification. The assumptions behind any planning illustration should not be mistaken for a protocol analysis plan or evidence about the primary endpoint. The record does not report the trial's statistical plan, any interim analyses, or an observed endpoint estimate from which to assess such planning.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Panoptix")
n      <- c(30)
events <- c(27)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Panoptix  30  27  90.0  73.5  97.9  74.4  96.5  74.2  96.4

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 10 outcome measures, including the primary spectacle-independence outcome and secondary visual-acuity and refractive measures. It does not report a multiplicity strategy, such as a hierarchy of outcome tests or an adjustment for examining several outcomes. It also lists no analyses. The registry record therefore does not establish which outcomes were formally tested, whether any tests were planned as confirmatory, or how multiplicity was handled.

In general, evaluating several outcomes can increase the chance of apparently notable findings arising by chance if each is assessed separately. Methods to address this issue depend on the analysis plan and the purpose of the outcomes. Without a reported plan or results, it is not possible to judge whether a particular adjustment was appropriate or whether any reported conclusion accounted for multiple assessments. No conclusion about multiplicity handling should be inferred from the outcome list alone.

Missing-data information is also not reported. The registry gives enrollment of 30 but does not state the number assessed at the primary 3-month time point, the amount or reasons for missing outcome data, or how missing responses were handled. It does not state whether participants were analyzed according to a defined analysis population or describe any rules for excluding observations. Consequently, the outcome denominator and the potential effect of missing data cannot be assessed.

These omissions matter because a result's interpretation depends on who contributed data and how incomplete observations were addressed. General approaches can make different assumptions about missing outcomes, and those assumptions can affect estimates. The record does not identify an approach, so none can be attributed to this study. The completed status and enrollment figure do not answer these analysis questions.

12. 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.

For the Panoptix group, the registry reports 30 participants at risk for serious adverse events and 0 affected. It reports 30 at risk for other adverse events and 0 affected, with 0 deaths. These are the posted counts in the safety fields; they do not provide a detailed listing of event terms, and no top serious-event terms are listed.

The figures should be read as counts within the recorded group, not as proof that no adverse events could occur. The registry record does not state the safety observation period, provide details about how events were collected, or describe whether all participants had complete safety follow-up. The counts also do not supply a comparison with another group, because no comparator arm is listed.

In general, a zero count in a study group describes what was recorded in that group over the applicable observation period. It does not establish the absence of risk beyond the observed participants or period. The registry record does not report enough detail to assess event ascertainment, exposure time, or the precision of the safety estimates. These figures should therefore be understood as the safety counts posted for this study, with those reporting limits in mind.

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

The registry record establishes that a completed device study was registered to assess spectacle independence after bilateral Panoptix implantation. It defines a primary patient-reported endpoint at 3 months and lists related visual-acuity and refractive outcomes. It also records enrollment of 30 and safety counts for the Panoptix group. These registry entries describe the registered design and posted information; they do not provide the numerical primary outcome result.

The record does not report how many participants met the spectacle-independence definition, the denominator for that assessment, or a percentage. It also does not provide a confidence interval or a statistical analysis of the endpoint. The central result therefore cannot be characterized as frequent or infrequent, precise or imprecise, based on the registry record alone. No claim about the direction or magnitude of an effect follows from the endpoint definition.

The study does not list a comparator arm, and allocation is not stated. For that reason, the registered information does not constitute a direct comparative estimate. In general, an outcome observed in one group cannot by itself show what would have occurred under another treatment or without the intervention. This limitation remains even if an outcome count is available; in this record, the primary count itself is not reported.

The listed secondary outcomes are relevant measures, but their names do not reveal their observed values. Similarly, the reported absence of recorded serious adverse events, other adverse events, and deaths should be read as counts in the registry, not as a guarantee about risk in other settings or populations. Details needed to assess completeness and duration of safety observation are not reported.

Overall, the record supports a description of the study question, the registered outcomes, and the recorded safety counts. It does not support a conclusion about the primary endpoint's observed frequency, comparative benefit, or statistical precision. Those questions require outcome results and analysis details that are not reported in the registry record.

14. Why This Trial Matters Statistically

This study raises a statistical issue that is common in clinical research: the registered question and endpoint can be clear while the numerical outcome needed to answer the question is not available in the registry record. Here, the primary endpoint specifies a patient-reported threshold and a 3-month assessment, but the observed count, denominator, and percentage are not reported. Without these elements, readers cannot evaluate the endpoint's frequency or its uncertainty.

The distinction between enrollment and outcome analysis is important. Enrollment of 30 identifies the registered enrollment, but it does not establish how many participants contributed a primary endpoint observation. A report of the number assessed and the handling of missing responses would help readers understand the basis of any estimate. Those details are not reported.

The study also illustrates why design and estimation answer different questions. A single listed intervention group can describe outcomes within that group, but without a comparator it cannot estimate a treatment contrast. Statistical methods cannot recover a missing comparison or replace information about allocation and follow-up. The record lists no analyses and does not describe a statistical plan, so readers cannot assess the intended analysis or its assumptions.

Finally, the named secondary measures indicate that visual function and refractive outcomes were considered alongside spectacle use. But a list of outcomes is not a result, and the record does not report their numerical findings. These distinctions matter for biostatisticians and clinical researchers because conclusions depend on observed data, denominators, analytic choices, and design—not on endpoint labels alone. The posted record is useful for identifying the study question and its reporting gaps, while leaving the primary statistical answer unresolved.

15. 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.

Several trial-specific limitations of interpretation follow from the registry record. It describes one Panoptix arm and no comparator, so the record does not support a direct comparison with another treatment. Allocation is not stated, and the record does not describe randomization. These registry entries restrict interpretation to the registered group and prevent a comparative effect from being estimated from the posted information.

The primary endpoint result is not reported. There is no observed count, percentage, denominator, or confidence interval for spectacle independence at 3 months. Although enrollment is 30, the record does not say how many participants completed the assessment or contributed data. This prevents evaluation of the endpoint estimate and its precision, and it leaves the possible effect of missing outcome data unclear.

The registry does not report eligibility details, participant characteristics, masking, recruitment procedures, or the specific conduct of outcome assessments. It names secondary measures but does not report their results. It also lists no analyses and does not describe the statistical analysis plan, multiplicity handling, or analysis populations. These omissions limit assessment of both the intended analyses and the robustness of any result.

The safety record reports no affected participants for serious or other adverse events and no deaths, but it does not specify the safety observation period or details of event ascertainment. These counts therefore cannot be fully contextualized. The completed status is not a substitute for posted outcome analyses, and none of the missing design or analysis details should be inferred from it.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: AcrySof® Bilateral PanOptix(R) Spectacle Freedom and Patient Satisfaction Study — NCT04126187.
• Registry record last updated 2023-09-21; status last verified 2023-09.
• Results first posted 2021-08-11.
• 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.

19. Record Summary

The registry record describes a completed device study sponsored by Gainesville Eye Associates, with enrollment of 30 and bilateral Panoptix trifocal intraocular lens implantation for participants with cataract. The recorded study dates are 2020-05-14 for the start and 2021-03-30 for primary completion.

The primary outcome is the count of participants meeting a patient-reported spectacle-independence definition at 3 months. The record lists 10 outcome measures, including binocular visual-acuity and refractive outcomes, but does not report numerical results or analyses. It lists no comparator arm, and allocation is not stated.

For the Panoptix group, the registry reports 0 participants affected by serious adverse events, 0 affected by other adverse events, and 0 deaths, with 30 at risk in each adverse-event category. The primary endpoint result, its denominator, missing-data handling, and statistical analysis plan are not reported in the registry record.