Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the Clareon PanOptix Intraocular Lens: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the Clareon PanOptix Intraocular Lens (NCT05518539), a registered phase not stated study. The primary outcome is Binocular Distance-corrected Near (40 cm) Visual Acuity.

2. Clinical Question

This is a question about visual performance after bilateral implantation, not a randomized comparison of the lens against another intervention. The planned primary measure focuses on near vision while distance correction is in place. Other listed outcomes cover uncorrected distance, intermediate, and near acuity; corrected distance acuity; distance-corrected intermediate acuity; manifest refraction; satisfaction; and visual disturbances. The registry lists 10 outcome measures overall.

That range of outcomes reflects distinct aspects of vision and patient experience. Acuity measures describe visual performance at specified distances and correction conditions; questionnaires address reported satisfaction or disturbances. They are not interchangeable measures, and a result for one would not by itself establish the findings for another. Because outcome values, participant characteristics, and analysis details are not reported in the registry record, the clinical question can be described, but the magnitude and precision of any observed change or performance cannot be assessed from this record.

3. Trial Design

The registry identifies NCT05518539 as a completed study sponsored by Newsom Eye & Laser Center. Its recorded start date is 2022-09-08, its primary completion date is 2024-06-14, and its enrollment is 30. The listed condition is cataract. The study evaluated visual outcomes and quality of vision following bilateral implantation of the Clareon PanOptix intraocular lens targeted for emmetropia.

The intervention entry describes the Clareon PanOptix Trifocal device, with toric and non-toric models. The arm description is bilateral implantation with those models. A comparator is not described, and allocation is not stated. The registry record therefore does not describe a randomized, controlled comparison or support a like-for-like comparison between treatment groups. Details such as eligibility criteria, recruitment approach, participant baseline characteristics, and the distribution of participants across lens models are not reported in the registry record.

The primary outcome is binocular distance-corrected near visual acuity at 40 cm, with a timeframe of one month postoperatively. It is specified as a continuous measure summarized by a mean and standard deviation in logMAR. Secondary outcomes include binocular uncorrected acuity at distance, intermediate, and near; binocular corrected distance acuity; binocular distance-corrected intermediate acuity; manifest refraction; a satisfaction questionnaire; and a visual disturbances questionnaire.

The registry marks the study completed, but completion status does not itself provide outcome findings. It records 10 outcome measures and 0 analyses. The primary endpoint result, secondary outcome results, analysis population, follow-up completeness, and statistical methods actually used are not reported in the registry record. The record also does not report a sample-size justification or explain how the enrollment target was selected.

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 Binocular Distance-corrected Near (40 cm) Visual Acuity, measured over 1 month postoperatively.

The primary endpoint is binocular distance-corrected near visual acuity measured at 40 cm, one month postoperatively. “Binocular” means the measure concerns vision using both eyes together. “Distance-corrected” indicates that distance correction is in place while near acuity is assessed. The unit is logMAR, and the registry specifies that the outcome is to be summarized as a mean with a standard deviation.

Near acuity is relevant to the stated evaluation of visual outcomes because it measures visual performance at a near working distance. Specifying the distance and correction condition makes the outcome more interpretable: it distinguishes this assessment from uncorrected near acuity and from acuity measured at intermediate or distance ranges. The endpoint is a continuous measure, so a mean can describe the group’s central result, while a standard deviation describes the spread of individual measurements around that mean. These summaries answer different questions; the standard deviation is not a measure of uncertainty in the estimated mean.

The registry names the endpoint but does not report its observed mean, standard deviation, participant count for the analysis, or a confidence interval. It also does not report a baseline value or specify a change-from-baseline analysis. Consequently, the record does not establish the magnitude, variability, or precision of the endpoint result. The endpoint definition alone describes what was intended to be measured, not what the study found.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes the primary endpoint as a continuous outcome summarized by a mean and standard deviation. A continuous measure can take values along a scale rather than only a set of categories. A mean gives a summary of the group’s measurements, whereas a standard deviation describes how dispersed those measurements are around the mean. The standard deviation should not be read as a confidence interval: it describes participant-level variability, not the precision of the group mean.

What would a confidence interval add?

In general, a confidence interval expresses uncertainty around an estimated quantity, such as a mean. Its width depends on the data and the analysis assumptions. A narrow interval indicates greater precision than a wide interval, but precision is not the same as clinical importance. To interpret an interval, readers need the estimate, the interval, and enough information about the analysis to understand what population and estimand it addresses. The registry record does not report a primary-endpoint estimate or confidence interval, so precision cannot be assessed.

What does the measurement scale mean?

The endpoint is expressed in logMAR. The registry provides that unit but does not state a clinically meaningful threshold or an interpretation rule for changes on the scale. General statistical interpretation should distinguish the numerical direction and size of an estimate from its practical importance. Without a reported estimate, baseline, comparison, or threshold, no such interpretation is possible for this study’s primary result.

Why do measurement conditions matter?

The primary measure is binocular, distance-corrected, and assessed at 40 cm. Each condition defines the outcome being measured. Binocular assessment concerns the combined use of both eyes; distance correction specifies the correction condition; and the stated distance identifies the near task. Results under other conditions—such as uncorrected near acuity or intermediate acuity—address different questions. The secondary outcomes listed in the registry should therefore be interpreted according to their own distance and correction conditions, rather than treated as alternate labels for the primary endpoint.

What can a one-group result establish?

In general, a study without a comparator can describe outcomes observed among participants who received an intervention, subject to its measurement and follow-up methods. It cannot, by itself, separate an intervention-associated outcome from other influences as a controlled comparison might. Here, the registry lists a bilateral implantation group and does not describe a comparator; allocation is not stated. The record does not provide results or design details that would permit a stronger causal interpretation.

How should planning calculations be read?

The registry’s planning assumptions describe an illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The stated fraction of the observed effect determines the planning target. These are planning assumptions, not a report of the trial’s own design or an observed power calculation. Sample-size illustrations describe hypothetical future planning under their assumptions; they do not establish the probability that this completed study detected an effect. The registry does not report the trial’s sample-size justification, and a planning illustration should not be interpreted as observed power.

General power calculations depend on choices such as the effect size to detect, variability, significance level, allocation, and analysis method. If the assumed effect is smaller, a larger study may be needed under otherwise comparable assumptions; if variability is greater, precision may be reduced. These are general principles, not findings about this study. The registry does not report the observed endpoint effect or variability needed to assess the relevance of an effect-based planning illustration.

Why does over-dispersion matter?

Over-dispersion is a general concern for count outcomes when their variability exceeds what a simple model assumes. In that situation, a model that understates variability can produce confidence intervals that are too narrow and statistical tests that are too optimistic. The primary endpoint is a continuous visual-acuity measure, not a count outcome, and the registry does not report the analysis model used. The general concept should not be mistaken for a description of the study’s actual analysis.

The registry reports 0 analyses, so it does not identify a fitted model, test statistic, p-value, or adjustment method for the primary outcome. None should be inferred from the endpoint description. The outcome’s planned summary by mean and standard deviation does not establish which inferential procedure, if any, was used.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("The Clareon™ PanOptix™ Trifocal (Toric and Non-tor")
n   <- c(24)
m   <- c(0)
sp  <- c(0.06)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  The Clareon™ PanOptix™ Trifocal (Toric and Non-tor  24  0.000  0.060  -0.025  0.025

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 10 outcome measures, including the primary visual-acuity endpoint and secondary measures of acuity, refraction, satisfaction, and visual disturbances. When a study examines multiple outcomes, multiplicity can arise because several statistical tests create multiple opportunities for a nominally notable result. General approaches may include identifying a primary endpoint in advance, controlling error across selected tests, or treating secondary findings as exploratory. The registry record does not report a multiplicity strategy, testing hierarchy, or adjustment method. It is therefore not possible to determine how multiplicity was handled.

The record identifies the primary endpoint and its timeframe but does not provide a statistical analysis plan or the results for that endpoint. It records 0 analyses. The planned outcome list should not be taken as proof that every listed measure was collected or analyzed, and no conclusion about the secondary findings can be made from their names alone.

Missing-data methods and the extent of missingness are not reported in the registry record. The record does not give the number of participants with evaluable primary-outcome data, reasons for missing measurements, or whether any imputation or sensitivity analysis was used. Enrollment of 30 does not establish how many observations contributed to any analysis.

The analysis population is also not reported in the registry record. It does not state whether analyses included all enrolled participants, only participants who received the intervention, or a subset with endpoint data. Without this information, an estimate’s target population and potential sensitivity to exclusions cannot be assessed. These gaps limit interpretation independently of the absence of outcome values.

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.

The registry lists safety figures for the Clareon PanOptix Trifocal group, including toric and non-toric models. For serious adverse events, 30 are listed as at risk and 0 as affected. For other adverse events, 30 are listed as at risk and 0 as affected. Deaths are recorded as 0. These entries describe the registry’s reported counts; they do not provide detailed event narratives or timing.

Zero affected in a registry entry means that no affected participants are recorded in that entry. It does not prove that an event is impossible or establish that the intervention has no safety risks. The record does not report the duration or completeness of safety follow-up, event definitions, collection procedures, or whether all participants had comparable observation. It also does not provide a comparator group for interpreting relative safety.

Safety counts should be considered alongside the study design and reporting context. The study is listed as completed, but completion status does not itself establish complete follow-up for every safety outcome. The listed at-risk figures and event counts do not supply the missing visual-outcome results, and they should not be interpreted as evidence about visual efficacy.

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

The registry record establishes the study’s stated purpose: evaluating visual outcomes and quality of vision after bilateral implantation of the Clareon PanOptix intraocular lens targeted for emmetropia. It also identifies the primary endpoint, measurement distance, correction condition, unit, summary measure, and postoperative timeframe. Those details clarify what the study was designed to assess.

What the record does not establish is the observed primary result. It does not report the mean or standard deviation for binocular distance-corrected near visual acuity at 40 cm, or a confidence interval describing its precision. It also does not report the listed secondary outcome values. As a result, the magnitude, variability, and statistical uncertainty of the visual outcomes cannot be characterized from the registry record.

The study description does not include a comparator group, and allocation is not stated. The record therefore does not provide a controlled estimate of how outcomes compare with another lens or intervention. Even if outcome measurements were available, findings from a group receiving bilateral implantation would need to be interpreted in light of participant selection, follow-up, measurement procedures, and other design details. Those details are not reported in the registry record.

The safety entries record 0 affected for serious adverse events, 0 affected for other adverse events, and 0 deaths, with 30 listed at risk in each adverse-event category. These are descriptive registry entries, not proof of an absence of risk, and the record does not provide the follow-up and ascertainment details needed for a fuller safety interpretation.

Accordingly, the study’s topic and planned measures are clear, but its posted outcome evidence is insufficient to judge the size or precision of visual results. This distinction matters: a completed registry record and a specified endpoint do not substitute for reported analyses. No claim that the intervention works or does not work follows from the information recorded.

14. Why This Trial Matters Statistically

This study is statistically informative as an example of the difference between a registered research question and a reported result. The record specifies a primary endpoint with a defined visual task, distance, correction condition, unit, summary measure, and postoperative timeframe. Such detail helps readers understand what the planned measure represents and distinguishes it from related secondary outcomes.

At the same time, the record lists 0 analyses and does not report outcome estimates. This makes the boundary of interpretation especially important. A clear endpoint does not tell readers what value was observed, how variable participants’ measurements were, or how precisely a group estimate was obtained. Without those elements, no assessment of effect magnitude or statistical uncertainty is possible.

The registry also illustrates why design context matters. It describes bilateral implantation and does not specify a comparator or allocation. A study can describe outcomes in an intervention group, but a comparative treatment effect requires an appropriate comparison and an analysis suited to that design. Readers should not infer a control comparison from the presence of multiple lens models in the intervention description.

The list of acuity, refraction, satisfaction, and visual-disturbance outcomes raises a further statistical consideration: multiple outcomes can support a broader account of performance, but their interpretation depends on prespecified priorities and methods for handling multiplicity. Those methods are not reported in the registry record. Similarly, the absence of analysis-population and missing-data details makes it harder to assess which observations would support any reported estimate.

These limitations do not answer the clinical question, but they clarify what the record can support: a description of the study’s question and registered measures, not a quantitative conclusion about visual performance. Transparent outcome reporting, uncertainty estimates, and analysis details are essential for moving from a planned measure to an interpretable statistical finding.

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.

The registry record omits the observed primary and secondary outcome values, despite identifying the planned measures. It records 0 analyses, so there are no reported estimates, confidence intervals, or inferential results to assess. This is the main limitation for interpreting visual outcomes.

The record does not report participant eligibility criteria, baseline characteristics, recruitment details, or the distribution of toric and non-toric lens models. It records enrollment of 30, but does not identify the number of participants with available endpoint measurements or the analysis population. The amount and handling of missing data are not reported in the registry record.

No comparator is described, and allocation is not stated. The registry therefore does not support a like-for-like control comparison. It also does not report a statistical analysis plan, a sample-size justification, multiplicity procedures, or the analysis method actually used. These omissions prevent evaluation of whether the analyses followed prespecified methods or how uncertainty was handled.

The primary endpoint has a one-month postoperative timeframe, but additional follow-up schedules and completeness are not reported in the registry record. The measurement procedures, assessment masking, and handling of repeated measurements are also not reported. For safety outcomes, the record lists at-risk and affected counts but does not detail ascertainment, event timing, or follow-up completeness.

These are limitations of the registry information available for interpretation; they do not establish that corresponding procedures were absent from the study. They mean that readers cannot verify those details from the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Evaluation of Quality of Vision and Visual Outcomes With Bilateral Implantation of the Clareon PanOptix Intraocular Lens — NCT05518539.
• Registry record last updated 2025-07-18; status last verified 2025-06.
• Results first posted 2025-07-18.
• 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

NCT05518539 is listed as a completed study sponsored by Newsom Eye & Laser Center, with enrollment of 30. The recorded start date is 2022-09-08 and the primary completion date is 2024-06-14. The condition is cataract.

The study evaluated visual outcomes and quality of vision following bilateral implantation of the Clareon PanOptix Trifocal intraocular lens, including toric and non-toric models, targeted for emmetropia. The primary endpoint is binocular distance-corrected near visual acuity at 40 cm, measured one month postoperatively and summarized by a mean and standard deviation in logMAR. The registry lists 10 outcome measures and 0 analyses.

The primary and secondary outcome results, analysis population, missing-data methods, and statistical analysis plan are not reported in the registry record. No comparator is described, and allocation is not stated. Safety entries list 0 affected for serious adverse events, 0 affected for other adverse events, and 0 deaths.