Vision Performance Evaluation of TECNIS EYHANCE™ With TECNIS SIMPLICITY™ Compared to TECNIS® 1-piece Intraocular Lenses: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Vision Performance Evaluation of TECNIS EYHANCE™ With TECNIS SIMPLICITY™ Compared to TECNIS® 1-piece Intraocular Lenses (NCT05025345), a randomized na study. The primary outcome is MONOCULAR BEST-CORRECTED DISTANCE VISUAL ACUITY (BCDVA).

2. Clinical Question

3. Trial Design

This was a prospective, randomized, double-masked, parallel-group clinical investigation of TECNIS EYHANCE and TECNIS 1-piece intraocular lenses in people with cataract. The brief summary describes a bilateral study with follow-up lasting six months. Participants were to receive the same assigned intraocular lens in both eyes. The first eye implanted was considered the primary study eye, and the primary visual-acuity endpoint was monocular.

The registry records 228 enrolled participants and a completed study. It lists a start date of 2021-09-02 and a primary completion date of 2022-06-17. The brief summary describes an intended enrollment of approximately 220 subjects, with approximately 200 randomized and bilaterally implanted participants anticipated, and approximately 100 evaluable subjects in each lens group at six months. Those anticipated figures are planning statements in the summary, not the same thing as the registry’s recorded enrollment or the numbers contributing data to each posted endpoint.

The investigation was expected to take place at up to 15 sites in the U.S.A. The sponsor is Johnson & Johnson Surgical Vision, Inc. The registry identifies the phase as NA. The randomized and masked design can reduce some forms of allocation and assessment bias, but those design labels do not by themselves establish how randomization was implemented or how masking was maintained. Those details are not reported in the registry record.

The record does not report the trial’s original statistical design assumptions, a sample-size justification, or the planned statistical analysis methods. It does post a sponsor analysis for the primary endpoint and a separate unadjusted recalculation based on the posted group summaries. These should be read as distinct analyses rather than assumed to share an identical model or analysis population.

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: A total of 228 subjects were enrolled and 214 subjects were treated. Of the 214 subjects, 107 were implanted with the test lens and 107 with the control lens. 4 subjects did not complete the study.

Overall Study

Analysis population for the primary outcome, as defined in the registry: The ITT (Intent-to-Treat) population for Monocular Best Corrected Distance Visual Acuity include all first eyes implanted with either a test or control IOL with data available at 6 months postoperative (i.e., no data imputation)

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 MONOCULAR BEST-CORRECTED DISTANCE VISUAL ACUITY (BCDVA), measured over 6 months.

The primary endpoint is monocular best-corrected distance visual acuity, abbreviated BCDVA, measured in LogMAR at six months. It is a continuous measurement, and the registry reports group means and standard deviations. The stated comparison is the mean difference for the first eye between the test-lens and control-lens groups.

Best-corrected distance visual acuity measures distance vision under best correction. In a randomized comparison, a group mean summarizes the observed outcome across the participants with endpoint data; the difference between group means describes the contrast between those group summaries. A continuous endpoint retains information about the measured values rather than reducing them to a binary category. Statistical interpretation still depends on the measurement, the analysis population, and the uncertainty around the estimated contrast.

The registry defines the primary ITT population as all first eyes implanted with either a test or control lens that had six-month postoperative data available, with no data imputation. Thus, the posted primary endpoint is not described as including participants without six-month data through an imputation procedure. The registry’s endpoint-level group counts are 103 for the test lens and 107 for the control lens. These counts describe the posted endpoint data and should not be conflated with the separate enrollment figure.

The registry also posts a sponsor non-inferiority analysis for this endpoint. A non-inferiority conclusion depends on comparing an estimated treatment contrast and its uncertainty with a prespecified margin. The margin and the details needed to evaluate that decision rule are not reported in the registry record, so the posted label alone does not establish whether the criterion was met.

7. Results Posted in the Registry

• Test Lens: mean -0.02 versus -0.03 on control; difference 0.01 (95% CI -0.02 to 0.04), standardized effect d = 0.12; z-test p = 0.401.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

MONOCULAR DISTANCE-CORRECTED INTERMEDIATE VISUAL ACUITY AT 66 CM (DCVA66)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • Test Lens: mean 0.23 versus 0.35 on control; difference -0.11 (95% CI -0.16 to -0.07), standardized effect d = -0.69; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Test Lens than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The registry posts one secondary endpoint: monocular distance-corrected intermediate visual acuity at 66 cm. Its statistical pattern differs from that of the primary endpoint. The secondary analyses report evidence of a group difference, whereas the primary unadjusted comparison does not provide strong evidence against a zero mean difference. This contrast is about the results for the specific measures and analyses recorded; it does not imply a general pattern across a broad set of unreported visual outcomes.

The secondary sponsor analysis is labeled superiority and uses a one-sided t-test. The unadjusted recalculation also reports a small p-value. These results should be interpreted in light of their endpoint-specific analysis and the absence of a posted sponsor confidence interval for the secondary outcome. They do not change the primary endpoint’s estimate or answer the primary non-inferiority question.

Secondary endpoints can help describe outcomes beyond the primary question, but they usually carry less confirmatory weight when the analysis plan, testing hierarchy, and multiplicity approach are not available. If multiple hypotheses are tested, the chance of obtaining at least one apparently notable result can increase. Adjustment procedures or prespecified ordering can address that issue, but neither is reported in the registry record. With only one secondary endpoint posted, the record still does not establish whether other outcomes were assessed or how all analyses were selected and interpreted.

Accordingly, the secondary result is best treated as a specific additional finding rather than as independent confirmation of the primary endpoint or evidence about every dimension of visual performance. The registry does not report a clinical-importance threshold for this measure, so statistical evidence of a group difference does not by itself establish the practical importance of that difference.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• MONOCULAR DISTANCE-CORRECTED INTERMEDIATE VISUAL ACUITY AT 66 CM (DCVA66)

9. Statistical Interpretation

10. Statistical Methods Explained

What does a mean difference describe?

A mean is a summary of the observed values in a group. For a continuous outcome such as LogMAR visual acuity, comparing group means gives an estimate of the average contrast between the randomized groups. The unadjusted recalculation uses the posted means and standard deviations for each group. It does not incorporate covariates or other adjustments, and it is not a substitute for the sponsor’s own analysis.

For the primary endpoint, the recalculated contrast is expressed as test lens minus control lens. Its estimate is 0.012. The ordering matters: reversing which group is subtracted from which would reverse the sign, even though the underlying separation of the group means would be the same. The sponsor’s reported primary estimate is -0.013. The registry does not report enough method detail to reconcile the sponsor estimate with the unadjusted recalculation, so they should be treated as separate posted results rather than forced into a single calculation.

What does a standard deviation add?

A standard deviation describes the spread of individual observations around a group mean. It is not the uncertainty of the mean itself. The primary endpoint group standard deviations are 0.09 for the test lens and 0.116 for the control lens. The unadjusted recalculation combines the group spread information for its comparison. A standard deviation can help describe how variable measurements were among participants, while a confidence interval for a difference addresses uncertainty about the estimated group contrast.

The registry also reports standard deviations for the secondary endpoint. Their presence does not establish that the endpoint analysis followed the same model as the primary sponsor analysis. For the secondary outcome, the sponsor’s analysis method is identified as a one-sided t-test. The primary sponsor analysis method is not specified in the registry record.

How should the p-value be read?

A p-value describes how unusual data at least as incompatible with a specified null hypothesis would be under the assumptions of the statistical test. It is not the probability that the null hypothesis is true, and it is not a measure of the size or importance of an effect. The primary unadjusted recalculation has p = 0.401. The secondary recalculation has p < 0.001, while the registry’s secondary sponsor analysis reports p < 0.001 using a one-sided t-test. These p-values belong to different endpoint analyses and should not be treated as interchangeable.

The secondary test is explicitly one-sided in the registry. A one-sided test evaluates evidence in a specified direction, whereas a two-sided test allows evidence in either direction. The registry’s stated planning illustration uses a two-sided significance level of 0.05; that planning assumption is not evidence that the trial’s original analysis used that same test. The original trial analysis plan is not reported in the registry record.

What is the role of randomization and masking?

Randomization is intended to make group assignment independent of participant characteristics, reducing systematic differences between groups on average. Masking subjects and evaluators can reduce the influence of expectations on reporting or assessment. These are general design principles. The registry records randomized allocation and double masking, but the procedures used to generate allocation, conceal assignment, or preserve masking are not reported in the registry record. The design labels therefore describe the recorded design without supplying those operational details.

What does the analysis population mean?

The primary endpoint population is described as first eyes with six-month postoperative data available. The registry calls this the ITT population, but its accompanying definition specifies available endpoint data and no imputation. In general, an intention-to-treat approach aims to analyze participants according to randomized assignment; handling participants without outcome data is part of the analysis specification. Here, the registry’s definition makes clear that missing six-month primary endpoint measurements were not imputed for this posted analysis. The number and reasons for missing measurements are not reported in the registry record.

The outcome counts are 103 for the test-lens group and 107 for the control-lens group. The record does not provide enough information to determine whether these counts reflect all randomized participants, exclusions after randomization, or any other flow through the analysis. They should be interpreted as the numbers attached to the posted endpoint summaries, not as a complete participant-flow account.

Why do the analyses need to remain distinct?

The sponsor’s primary result is labeled non-inferiority and includes a 90% confidence interval. The unadjusted recalculation is a simple comparison from posted summary statistics. These approaches may address different estimands or use different assumptions, but the registry does not report the sponsor method or enough detail to identify the precise source of their differing results. The discrepancy flag is false; that does not make the calculations identical. It means the registry’s recorded discrepancy status does not mark a discrepancy, while the displayed estimates still need to be described according to their own stated methods.

General statistical interpretation requires attention to the endpoint, contrast direction, analysis population, model, and interval. When some of those elements are not reported, conclusions should remain limited to the estimates and analyses that are explicitly posted. In particular, the missing non-inferiority margin prevents independent evaluation of the sponsor’s non-inferiority decision rule.

11. Confidence Intervals and Precision

A confidence interval expresses uncertainty around an estimated contrast under the assumptions of the method used. A narrower interval represents greater statistical precision than a wider interval for the same kind of estimate. An interval that includes zero is compatible with no mean difference under the interval’s method, as well as with values on either side of zero. It does not prove that the true difference is zero.

For the primary sponsor analysis, the registry reports an estimate of -0.013 and a 90% confidence interval from -0.036 to 0.011. The interval includes zero. The registry does not report the non-inferiority margin, so the interval cannot be compared with that decision threshold from the record alone.

The unadjusted primary recalculation reports an estimate of 0.012 and interval limits of -0.016 and 0.04. The confidence level for this recalculated interval is not stated in the registry record. It also includes zero. Its limits are not the same as those in the sponsor’s reported analysis, and the two intervals should not be treated as if they came from one common method.

The secondary recalculation’s interval runs from -0.157 to -0.069 around an estimate of -0.113. The registry does not post a sponsor confidence interval for that secondary endpoint. The secondary sponsor result is instead reported as a one-sided test. Thus, the available precision information is not identical across the endpoints.

Intervals quantify statistical uncertainty, not the importance of a difference to participants or clinicians. The registry does not report a clinical-importance threshold for either outcome. The intervals also do not account for uncertainties that cannot be assessed from the record, such as missing-data patterns or the appropriateness of model assumptions. Interpretation should therefore consider both the posted interval and the analysis details that are absent.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are participants per arm, not total events. They are illustrations based on the observed effect and are not the original trial’s sample-size calculation. The listed assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is specified as a fraction of the observed effect. The trial’s own original design assumptions are not reported in the registry record.

The 80% power column describes the number of participants per arm estimated to give an 80% chance of detecting the stated effect under the planning assumptions, if that effect and those assumptions applied. The 90% power column gives the corresponding planning target for a 90% chance. Power is a property of a planned design under specified assumptions; it does not describe the probability that a particular result is true.

The rows illustrate planning for 100% of the observed effect, 75% of the observed effect, and 50% of the observed effect. As the effect to be detected becomes smaller, more participants are needed to distinguish it from sampling variation with the same significance level and target power. The listed figures are therefore sensitive to the observed effect used as their starting point, and should not be read as a recommendation for a future study without considering its design and objectives.

The plotted planning curve represents this relationship between the assumed effect and required participants per arm. It does not add evidence about the trial’s observed outcome. These sample-size illustrations are not observed power: they are planning calculations derived from the posted effect and stated assumptions, not a retrospective measure of what the completed trial achieved.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 0.012; pooled standard deviation σ = 0.104.
2. n = 2 × (1.96 + 0.842)² × 0.104² / 0.012² = 1,180.5, rounded up to 1,181 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 0.012                      # observed difference in means
sigma <- 0.104064883606335                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(5025345)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 1,181 (80% power), 1,581 (90% power)
 75% of observed effect: n per arm = 2,099 (80% power), 2,810 (90% power)
 50% of observed effect: n per arm = 4,723 (80% power), 6,322 (90% power)
power.t.test: 1181.5 
Simulated power at n = 1,181 per arm: 0.799 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Analyses Reported by the Sponsor

The registry’s sponsor analysis for the primary endpoint reports a mean difference of -0.013, a 90% confidence interval from -0.036 to 0.011, and a non-inferiority analysis label. It does not report a p-value or identify the statistical method for this primary analysis. Most importantly for interpreting the non-inferiority label, the margin is not reported in the registry record.

The recalculation is a simple unadjusted comparison of the posted group summaries. It estimates a test-minus-control mean difference of 0.012, gives interval limits of -0.016 and 0.04, and reports an unadjusted p-value of 0.401. It is not the sponsor’s analysis and does not replace it. Its interval’s confidence level is not reported in the registry record.

The sponsor estimate differs from the recalculated estimate in sign and magnitude. The registry does not describe the sponsor method in enough detail to determine why, so the estimates should be reported separately rather than explained by speculation. The discrepancy status is false. The sponsor’s analysis takes precedence when the discrepancy status is true; that condition is not recorded for this trial. Even so, the sponsor’s reported result remains the registry’s own primary analysis, while the recalculation remains a transparent summary-statistic comparison. Neither can be used to verify the non-inferiority criterion without the margin and relevant analysis details.

15. Multiplicity, Missing Data and Analysis Populations

The registry identifies a primary endpoint and one posted secondary endpoint. It lists two outcome measures and two analyses. The secondary sponsor analysis is labeled superiority and reports a one-sided t-test. The primary sponsor analysis is labeled non-inferiority, but its method is not specified. The trial’s full statistical analysis plan, including any prespecified order of testing, is not reported in the registry record.

Multiplicity refers to the interpretive challenge created by conducting multiple statistical tests or examining multiple outcomes. When many comparisons are considered, a result that appears statistically notable can arise by chance more often than when a single comparison is planned. Methods such as adjusted significance thresholds or a hierarchy of hypotheses can help control interpretation, but the registry does not report whether such methods were planned or used. The posted unadjusted recalculations should therefore be read as unadjusted results, not as multiplicity-controlled evidence.

The record defines the primary endpoint population as first eyes with six-month postoperative data available and explicitly states that no data imputation was used. This clarifies how missing primary endpoint values were handled for that analysis, but it does not report how many measurements were missing or why. The registry’s use of the term ITT should be read together with its stated available-data definition; it does not mean that missing values were imputed.

The missing-data approach for the secondary endpoint is not reported in the registry record. The record also does not provide a participant-flow account sufficient to describe all randomized participants, withdrawals, or endpoint-specific exclusions. Without those details, it is not possible to assess whether missing outcome data differed between groups or how that might affect the estimates.

Interim analyses, stopping rules, and the original statistical plan are not reported in the registry record. Their absence from the record should not be filled by assumptions. The available interpretation is therefore limited to the posted endpoint definitions, group summaries, and reported analyses.

16. 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 1% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: cystoid macular edema (1.9%), lymphoma (0.9%), hospitalization (0.9%), refractory cytopenia with multilineage dysplasia (0.9%), mitral valve defect (0.9%).

The registry reports serious adverse events for 5 of 107 participants at risk in the test-lens group and 4 of 107 at risk in the control-lens group. It reports other adverse events for 1 of 107 at risk in the test-lens group and 0 of 107 at risk in the control-lens group. The death counts are 2 for the test-lens group and 0 for the control-lens group. These are separate posted counts; the record does not provide enough detail to infer timing, cause, or relationship to the lens.

The registry lists cystoid macular edema at 1.9% among the serious-event terms, followed by lymphoma, hospitalization, refractory cytopenia with multilineage dysplasia, mitral valve defect, and ischemic optic neuropathy, each at 0.9%. Those terms describe the reported event listings. They do not establish that an event was caused by a lens or by participation in the study.

Safety counts should be interpreted with the recorded at-risk denominators and the available follow-up and event definitions. The registry record does not provide further detail about event timing, severity criteria, relatedness assessments, or how deaths were classified. The counts alone do not support a causal comparison or a broader safety conclusion.

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

The results describe measured visual-acuity outcomes in a randomized comparison of TECNIS EYHANCE and TECNIS 1-piece intraocular lenses. For the primary endpoint, the registry reports group means and a sponsor non-inferiority analysis, alongside an unadjusted recalculation from summary statistics. The recalculated primary interval includes zero and its p-value is 0.401. The sponsor’s reported estimate and 90% interval are different from the recalculation, and the registry does not report the non-inferiority margin needed to assess the sponsor’s decision rule.

The secondary endpoint has a different statistical pattern, with a posted sponsor superiority analysis and a small p-value in the unadjusted recalculation. That finding applies to the particular secondary measure and analysis. It does not establish a difference across all visual functions, nor does it convert the primary result into a positive or negative finding.

Statistical significance and clinical importance are not the same. A p-value indicates how the data compare with a statistical null under assumptions; it does not describe how meaningful an observed difference is to participants. The record does not state a threshold for a clinically important difference for either endpoint. Confidence intervals describe uncertainty, but they cannot resolve missing design and analysis information.

The record also does not provide the original sample-size justification, a complete statistical analysis plan, details about missing outcome patterns, or the non-inferiority margin. These omissions limit independent assessment of the sponsor’s analysis and the strength of confirmatory interpretation. The posted data support a careful account of the reported comparisons, but they do not establish causality for individual adverse events or justify a broad claim beyond the outcomes measured and recorded.

This statistical interpretation is not medical advice. Decisions about an individual’s care require clinical assessment beyond the registry results.

18. Why This Trial Matters Statistically

This trial illustrates why a result should be read through its endpoint definition, analysis population, comparison method, and uncertainty rather than through a single p-value. The primary outcome is a continuous visual-acuity measure, and the registry supplies group means, standard deviations, and a sponsor non-inferiority result. The accompanying unadjusted recalculation offers a separate view based on the posted summary statistics. The estimates are not identical, making it important to keep the sponsor analysis distinct from the recalculation.

It also illustrates that a non-inferiority label is not self-interpreting. The estimate and interval need to be considered against the prespecified margin, but that margin is not reported in the registry record. Without it, the registry’s label cannot be independently checked using the posted information alone.

The secondary result shows why endpoint hierarchy and multiplicity matter. A secondary analysis can provide useful additional information, but its evidential role depends on what was planned, how many comparisons were made, and whether adjustments or a testing order were used. Those details are not reported. The difference between the primary and secondary statistical patterns should therefore be described without treating the secondary result as a replacement for the primary question.

Finally, the registry distinguishes the endpoint analysis counts from the recorded enrollment and supplies a primary population definition based on available six-month data without imputation. That makes the stated analysis population important to interpretation, while also highlighting how missing-data counts and participant flow would help assess completeness. Overall, the case demonstrates the value of transparent methods and uncertainty reporting in clinical research.

19. 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 does not report the non-inferiority margin for the primary endpoint. Without that threshold, the posted non-inferiority label and interval cannot be independently evaluated against the criterion that defines non-inferiority. The primary sponsor analysis method is also not reported, limiting comparison with the simple unadjusted recalculation.

The sponsor’s primary estimate differs from the recalculated estimate in sign and magnitude. The record does not explain the source of that difference. The recalculation is based on posted group summaries and should not be treated as a reproduction of an analysis whose methods are not stated. The confidence level for its interval is also not reported.

The primary endpoint population includes first eyes with data available at six months and uses no imputation. The record does not report the number or reasons for missing measurements, the missing-data approach for the secondary endpoint, or a complete participant-flow account. These gaps limit assessment of how missingness could affect the estimates.

The full statistical analysis plan, multiplicity strategy, interim analyses, and original sample-size justification are not reported in the registry record. The planning illustrations based on observed effects do not supply those missing design details. The record also does not state clinical-importance thresholds for the visual-acuity outcomes.

Safety reporting gives event counts and selected serious-event terms but does not report timing, causes, relatedness assessments, or further event-level context. The posted information therefore supports description of the listed counts, but not an independent causal assessment. These limitations concern the information available in the registry record and should not be mistaken for evidence that an unreported procedure or analysis did or did not occur.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Vision Performance Evaluation of TECNIS EYHANCE™ With TECNIS SIMPLICITY™ Compared to TECNIS® 1-piece Intraocular Lenses — NCT05025345.
• Registry record last updated 2023-08-28; status last verified 2023-08.
• Results first posted 2023-08-28.
• 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.

23. Record Summary

NCT05025345 is a completed, randomized, double-masked, parallel-group study of TECNIS EYHANCE and TECNIS 1-piece intraocular lenses in participants with cataract. The registry records enrollment of 228, a start date of 2021-09-02, and a primary completion date of 2022-06-17. The brief summary describes a prospective bilateral investigation with six-month follow-up and the same assigned lens implanted in both eyes.

The primary endpoint is first-eye monocular best-corrected distance visual acuity at six months, measured in LogMAR. The record posts a sponsor non-inferiority analysis and a distinct unadjusted recalculation. One secondary endpoint, distance-corrected intermediate visual acuity at 66 cm, is also posted. The record includes serious and other adverse-event counts and death counts.

Important interpretation details, including the non-inferiority margin, primary sponsor method, full statistical plan, and missing-data counts, are not reported in the registry record. The posted estimates should be read with those limitations and with the distinction between sponsor analyses and unadjusted recalculations in view.