Evaluation of Clareon Vivity/Vivity Toric: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluation of Clareon Vivity/Vivity Toric (NCT05852470), a non-randomized na study. The primary outcome is Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant.

2. Clinical Question

3. Trial Design

This is a completed post-market clinical follow-up study of Clareon Vivity/Vivity Toric and Clareon Monofocal/Clareon Toric intraocular lenses. The registry lists phase as NA, allocation as non-randomized, masking as single, and the model as parallel. These labels describe the registered design; the identity of the masked party and the details of masking procedures are not reported in the registry record.

The study enrolled 155 participants. Its two arms are defined by previous bilateral implantation: Clareon Vivity/Vivity Toric Extended Vision IOL, or Clareon Monofocal/Clareon Toric IOL. The arm descriptions place the relevant follow-up 90-180 days after implantation in the second eye. The stated purpose is to generate clinical data in previously implanted subjects and assess key performance endpoints for model-specific clinical benefit statements.

The registry lists a study start date of 2023-05-23, primary completion of 2023-10-27, and status of COMPLETED. It does not report the recruitment process, eligibility criteria beyond the information in the arm descriptions, or the reason that a participant received one lens group rather than the other. Those details matter when interpreting differences between groups: non-random assignment can leave groups different in ways that affect measured outcomes.

The primary endpoint is mean binocular photopic best corrected distance visual acuity at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant. A listed timeframe describes Visit 1 as Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation. The registry also lists secondary outcomes for near visual acuity and a response to an intraocular lens satisfaction questionnaire. The full analysis procedures and the result estimates are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: Of the 155 enrolled, 5 participants were exited as screen failures. This reporting group includes all eligible subjects (150).

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: FAS. Note: One subject in the Clareon Monofocal/Clareon Toric arm discontinued after Visit 0; thus, the data from this subject at this visit is not included.

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: Full Analysis Set (FAS): All subjects/eyes bilaterally implanted with the test or comparator IOL

6. Primary Endpoint

The registry lists the primary outcome as Mean Binocular Photopic Best Corrected Distance Visual Acuity (BCDVA) at 3 to 6 Months (90 to 180 Days) Postoperatively After Second Eye Implant, measured over Visit 1 (Day 1-14 post Screening Visit, coinciding with Day 90-180 post second eye implantation).

The primary endpoint is mean binocular photopic best corrected distance visual acuity (BCDVA), assessed after the second-eye implant. Visual acuity was assessed with best refractive correction in place, under photopic, or well-lit, conditions, at a distance of 4 meters (m) using a visual acuity chart. Both eyes were assessed together, making this a binocular, subject-based measure rather than a separate result for each eye.

The measure is recorded in logMAR. The registry explains that a logMAR value of 0 equates to 20/20 Snellen visual acuity and that a lower logMAR value indicates better visual acuity. This direction is important when reading any group estimates: a lower mean logMAR represents better measured acuity on this scale. The endpoint is intended to describe distance visual acuity under the specified correction and lighting conditions.

The registry calls the endpoint a co-primary endpoint, but does not identify the other co-primary endpoint in the record. Although the endpoint title specifies a mean and the measure is continuous, the group means, standard deviations, and comparison estimates are not reported in the registry record. As a result, the record does not establish the magnitude or precision of group differences in this endpoint.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical interpretation depends on how the outcome is defined, who contributes data, and how uncertainty is represented. The registry identifies a continuous primary outcome, its unit, the population label, and the assessment period. It does not report the numerical endpoint estimates or a complete statistical analysis plan, so the discussion below explains general concepts without attributing unreported procedures to this study.

What a mean and standard deviation describe

For a continuous measure such as logMAR visual acuity, a mean describes the average observed value in a group. It gives a concise summary but does not show how individual values are distributed. The standard deviation describes the spread of individual observations around the group mean. A smaller spread indicates that observations are more closely clustered around the mean; a larger spread indicates greater variability. A standard deviation is not itself a confidence interval and does not directly give the uncertainty in a group comparison.

Because lower logMAR values indicate better visual acuity, the direction of any mean difference must be interpreted on that scale. The record does not report group means, standard deviations, or a mean contrast. No numerical comparison can therefore be reconstructed from the registry entry, and no conclusion about the observed size of a contrast is warranted from the endpoint description alone.

What a confidence interval would add

In general, a confidence interval presents a range of values compatible with the data and the statistical procedure used. Its width conveys precision: narrower intervals indicate more precise estimates, while wider intervals indicate less precision. The interval must be read with the estimate and with the scale’s clinical and statistical context. The registry record does not report a confidence interval for the primary endpoint, nor does it give enough summary statistics to calculate one without introducing assumptions.

A confidence interval would not repair the non-randomized design. It describes sampling uncertainty under the analysis assumptions, but does not automatically account for differences between groups that existed before or apart from the study. Potential confounding and selection processes remain relevant even when an estimate is precise.

Why allocation matters

Random allocation is one way to make groups comparable in expectation. This study is registered as non-randomized, and the record warns that the arms are not a like-for-like control comparison. The record does not explain how subjects entered each arm or report adjustment for baseline differences. Consequently, even if a numerical group contrast were available, interpretation would need to distinguish an observed association from a causal effect of the implanted device.

Single masking is listed, but the masked party and operational details are not reported in the registry record. Masking can reduce some forms of measurement or reporting bias in general, depending on who is masked and how outcomes are collected. The label alone does not establish which possible biases were addressed in this study.

How to read the outcome timing

The primary outcome is assessed at a postoperative visit described as coinciding with Day 90-180 after second-eye implantation. The arm descriptions likewise define prior implantation in relation to 90-180 days after the second-eye procedure. A window rather than one common assessment day means that the exact timing may vary among subjects, though the actual distribution of assessment times is not reported in the registry record. The listed timeframe also describes Visit 1 as Day 1-14 post Screening Visit. The record does not report how timing variation was handled statistically.

Over-dispersion and count outcomes

General statistical context: over-dispersion occurs when count data vary more than a chosen model assumes. It can make uncertainty estimates too small if the model does not allow for the extra variability. The posted primary endpoint is a continuous mean, not a count outcome, and the registry does not report a count-model analysis for it. No conclusion about over-dispersion or a model choice can be made for this study from the record.

For safety summaries, counts of affected subjects are descriptive quantities. Their interpretation depends on the event definitions, how events were collected and attributed, the length and completeness of observation, and the number of people at risk. Those details are not reported in the registry record. Zero affected counts in the listed categories are therefore a report of the recorded summaries, not an estimate that future risk is zero.

Planning illustrations are not observed power

In general, sample-size planning asks how many participants would be needed under stated assumptions to detect a chosen effect with a specified error rate and power. Such calculations depend on assumptions about the outcome, variability, effect size, allocation, and analysis. Any planning illustration based on an observed effect is not the trial’s design justification and is not observed power. The registry does not report its original sample-size justification or the assumptions used to plan enrollment, so those cannot be inferred from the study’s enrollment alone.

The registry describes planning assumptions for an illustration, including a two-sided significance level of 0.05, equal allocation, and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect. The primary endpoint’s observed result is not reported in the registry record, so the inputs and resulting planning quantities cannot be independently interpreted from the registry entry alone. Such illustrations, where displayed with the statistical results, should be understood as conditional planning exercises rather than evidence about the trial’s actual power.

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("Clareon Vivity/Vivity Toric", "Clareon Monofocal/Clareon Toric")
n   <- c(73, 75)
m   <- c(-0.028, -0.062)
sp  <- c(0.1165, 0.0847)
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  Clareon Vivity/Vivity Toric  73  -0.028  0.117  -0.055  -0.001
CARM  Clareon Monofocal/Clareon Toric  75  -0.062  0.085  -0.081  -0.043

11. Multiplicity, Missing Data and Analysis Populations

The registry lists four outcome measures and four analyses. It names two secondary outcomes: mean binocular photopic distance corrected near visual acuity at 3 to 6 Months (90 to 180 Days) after second-eye implantation, and the percentage of subjects who respond “Never” to Question 1 of the IOLSAT questionnaire over the same postoperative period. The primary visual acuity endpoint is explicitly described as a co-primary endpoint, but the other co-primary endpoint is not reported in the registry record.

When a study evaluates multiple outcomes or makes multiple statistical comparisons, the chance of at least one apparently notable result can increase. General approaches to multiplicity include defining a hierarchy, adjusting significance thresholds, or treating selected outcomes as descriptive. The registry record does not report whether any multiplicity procedure was planned or used, how co-primary endpoints relate to one another, or how conclusions would depend on their results. No claim about statistical significance across endpoints can be made without the corresponding results and analysis plan.

The primary analysis population is described as FAS. The record notes that one subject in the Clareon Monofocal/Clareon Toric arm discontinued after Visit 0 and that the subject’s data at this visit were not included. The number of subjects contributing to each analysis, the definition of FAS, and the treatment of other missing values are not reported in the registry record. Missing-data assumptions, imputation procedures, sensitivity analyses, and reasons for missing observations are also not reported.

These omissions limit assessment of whether the analyses followed a prespecified plan and whether missingness could influence the observed summaries. The enrollment count cannot substitute for the outcome-specific denominators, and the single discontinuation note does not establish that all other outcome data were complete.

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 5% reporting threshold.

The registry lists safety groups for the Clareon Vivity/Vivity Toric arm and the Clareon Monofocal/Clareon Toric arm. For each arm, it separates ocular summaries for the first eye and second eye from a systemic summary. In every listed group, the serious-event affected count is 0, the other-event affected count is 0, and deaths are 0. The at-risk counts shown are 73 for each Vivity/Vivity Toric group and 76 for each Monofocal/Clareon Toric group.

These are descriptive registry counts. They should be read with the group labels intact: ocular summaries are eye-specific, while systemic summaries are subject-based where indicated. The at-risk counts identify the group sizes used in these summaries, but the registry record does not report the duration of safety observation, event collection methods, event definitions, or whether the groups had comparable exposure and follow-up.

A zero affected count means that no affected subjects were recorded in that listed category in the posted summary. It does not establish that the true probability of an event is zero, nor does it rule out events outside the recorded definitions or observation period. The registry’s serious adverse event terms list is empty. This provides no event terms to characterize, but the record does not give further narrative about safety ascertainment or completeness.

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

The registry record identifies a completed, non-randomized, parallel post-market follow-up study and defines its main visual acuity endpoint. It gives the endpoint’s measurement conditions, unit, scale direction, and postoperative assessment window. These details clarify what the planned comparison concerns: mean binocular distance visual acuity under photopic conditions with best refractive correction, measured after implantation in both eyes.

However, the numerical primary endpoint results are not reported in the registry record. Without group means, variability, a contrast, and uncertainty estimates, the observed level of acuity and the precision of any group difference cannot be described. The record also does not supply the numerical results for its listed secondary outcomes. A design description is not a result, and the endpoint definition alone cannot show whether groups differed.

The study’s non-randomized allocation is an important limit on interpretation. Participants were not assigned to the lens groups through randomization as described in the record, which cautions against treating one arm as a directly comparable control. The registry itself states that the arms are not a like-for-like control comparison. Any available difference would need to be considered alongside possible baseline group differences and the process determining prior implantation; those details are not reported in the registry record.

The posted safety summaries record 0 serious-event affected and 0 other-event affected in the listed categories, and 0 deaths. These counts describe what is recorded for the stated at-risk groups; they do not demonstrate absence of all possible safety events or quantify risk beyond the observed summaries. Details needed to evaluate completeness and duration of safety follow-up are not reported.

Accordingly, the record supports a description of the study’s purpose, design, measurement, and reported adverse-event counts. It does not support a quantitative claim about comparative visual acuity, a causal claim about device effects, or a broad conclusion about safety beyond the listed summaries.

14. Why This Trial Matters Statistically

This study is statistically notable because it asks a focused question about a continuous, binocular visual acuity measure in people with previous bilateral implantation. The scale and assessment conditions are specified, and the scale’s direction is explicit: lower logMAR indicates better visual acuity. That clarity is necessary for interpreting a mean when one is available, and helps prevent a reversal of the result’s direction.

The comparison also illustrates why design features matter as much as outcome definitions. The study is non-randomized, and the registry cautions that its arms are not a like-for-like control comparison. This means that statistical summaries of the groups, even if precise, would not alone establish that the lens group caused any difference. Understanding how participants came to receive each lens and how their characteristics compare is central to evaluating a contrast; those details are not reported in the registry record.

The co-primary designation and multiple listed outcomes make analysis transparency relevant. The record does not identify the other co-primary endpoint or explain how multiple endpoints were handled. Without a reported plan and outcome estimates, readers cannot evaluate the multiplicity strategy or determine how the primary and secondary findings fit together.

The record also distinguishes study enrollment from the analysis population and notes a visit-specific exclusion after discontinuation. That reminder is important: denominators can differ by endpoint and visit, and missing observations may affect interpretation. The outcome-specific denominators and missing-data procedures are not reported.

Finally, the zero affected counts in the posted safety summaries have a clear descriptive meaning but limited reach. Without details on ascertainment and follow-up, they should not be generalized beyond the listed groups and categories. Taken together, the record is useful for understanding the intended clinical question and its statistical boundaries, while leaving the comparative outcome findings unreported.

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 most direct limitation is that the registry record does not report numerical results for the primary visual acuity endpoint. It therefore does not permit assessment of group means, between-group contrast, variability, or precision. Numerical findings for the listed secondary outcomes are also not reported in the registry record.

The non-randomized allocation limits causal interpretation, and the registry explicitly warns that the arms are not a like-for-like control comparison. The record does not describe how subjects were selected into each group or provide baseline characteristics that would help evaluate comparability. Adjustment methods, if any, are not reported.

The primary endpoint is identified as co-primary, but the other co-primary endpoint and the multiplicity strategy are not reported in the registry record. The statistical analysis plan, including model choice and the handling of repeated or incomplete measurements, is not reported. The FAS label is given, but its full definition and the outcome-specific analysis counts are not reported.

One subject in the Monofocal/Clareon Toric arm discontinued after Visit 0 and was not included at the primary endpoint visit. The record does not explain the reason for discontinuation or describe other missing data, missingness assumptions, imputation, or sensitivity analyses. The enrollment count of 155 should not be assumed to equal the analysis population for every measure.

Single masking is listed, but the masked party and procedures are not reported. The visit window spans 90-180 days after second-eye implantation, while the distribution of actual visit timing and its treatment in analysis are not reported. Safety counts are available, but event ascertainment, exposure duration, and completeness of follow-up are not described. These limits constrain interpretation of both effectiveness estimates and adverse-event summaries.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Evaluation of Clareon Vivity/Vivity Toric — NCT05852470.
• Registry record last updated 2026-02-24; status last verified 2026-02.
• Results first posted 2024-11-05.
• 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 describes NCT05852470, titled “Evaluation of Clareon Vivity/Vivity Toric,” as a completed post-market clinical follow-up evaluation sponsored by Alcon Research. It lists enrollment of 155, non-randomized allocation, single masking, and a parallel model. The study compares previously implanted Clareon Vivity/Vivity Toric Extended Vision IOLs with Clareon Monofocal/Clareon Toric IOLs.

The primary outcome is mean binocular photopic BCDVA in logMAR at 3 to 6 Months (90 to 180 Days) after the second-eye implant. The endpoint is labeled co-primary. Secondary outcomes concern near visual acuity and a response to the IOLSAT questionnaire. The numerical efficacy results and the other co-primary endpoint are not reported in the registry record.

The posted adverse-event summaries list 0 serious-event affected, 0 other-event affected, and 0 deaths in each listed group. The record notes one visit-specific exclusion in the Monofocal/Clareon Toric arm and cautions that the non-randomized arms are not a like-for-like control comparison.