Investigation of the Safety and Effectiveness of a Trifocal IOL: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Investigation of the Safety and Effectiveness of a Trifocal IOL (NCT04176965), a randomized na study. The primary outcome is Mean Photopic Monocular logMAR Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters in First Operative Eyes.

2. Clinical Question

3. Trial Design

This was a prospective, multicenter, randomized, double-masked, parallel-group confirmatory trial comparing an investigational trifocal intraocular lens with a commercially available monofocal intraocular lens. The registry lists the study as completed and gives enrollment as 539. The listed study dates are 2022-04-28 for start and 2024-05-13 for primary completion. The phase is listed as not applicable.

The investigational arm received FINEVISION HP; the control arm received Alcon AcrySof SN60AT. The arm descriptions specify removal of the cataractous lens and implantation of the assigned device in the capsular bag. Random allocation is relevant because it is intended to create groups that are comparable at the outset, while masking can reduce the influence of knowledge of assigned treatment on trial conduct or outcome assessment. The registry identifies the design as randomized and double masked, but further details of allocation procedures and masking implementation are not reported in the registry record.

The primary endpoint uses first operative eyes, rather than treating both eyes as independent observations in that primary comparison. The reported population is the All-Implanted Analysis Set with data available at the visit. The endpoint timeframe is 150-180 days after surgery on the first eyes. The displayed arm sizes for that endpoint are 332 for FINEVISION HP and 164 for Control Product. These are the analysis counts for the posted outcome, not a description of the original enrollment target.

The registry lists 10 outcome measures and 26 analyses, and posts three secondary outcome measures. It also reports secondary measures concerning intermediate acuity, adverse events, and visual disturbances assessed with the Quality of Vision questionnaire and supplemental questions. The original protocol’s sample-size justification, detailed randomization procedures, and complete statistical analysis plan 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 539 enrolled, 27 exited as screen failures prior to randomization. A total of 512 Participants were randomized in a ratio of 2:1 to receive either the FINEVISION HP Trifocal Intraocular lens (IOL) or the AcrySof SN60AT Monofocal IOL (control) IOL in both eyes. 16 participants discontinued after randomization but before implantation. A total of 496 participants were implanted with either FINEVISION HP Trifocal IOL or the control IOL (3 subjects unilaterally, 493 subjects bilaterally).

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: All-Implanted Analysis Set- First Operative Eyes with data available at the visit

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: This analysis population includes all participants with successful IOL implantation with at least 1 post-operative visit (All-Implanted Analysis Set).

6. Primary Endpoint

The registry lists the primary outcome as Mean Photopic Monocular logMAR Best Corrected Distance Visual Acuity (BCDVA) at 4 Meters in First Operative Eyes, measured over 150-180 days after surgery on the first eyes.

The primary endpoint is mean photopic monocular logMAR best corrected distance visual acuity (BCDVA) at 4 meters in first operative eyes, assessed 150-180 days after surgery on the first eyes. Monocular testing means each eye is assessed separately. The registry describes testing under photopic, or well-lit, conditions using the correction from manifest refraction and electronic ETDRS charts on a CTS device. The scale is logarithm of the minimum angle of resolution; the record explains that a lower or negative value represents better acuity and that a 0.02 logMAR increment corresponds to a single letter on an ETDRS chart.

This endpoint is useful for comparing average corrected distance acuity under standardized testing conditions. It focuses on a defined visual function and a defined follow-up window, making group means interpretable as an average measure rather than an account of each participant’s experience. Best correction is relevant because the assessment uses the correction obtained from refraction, so the comparison concerns acuity with that correction rather than unaided vision.

The endpoint is not a complete measure of visual performance. It does not directly capture intermediate or near acuity, visual disturbances, or every adverse event. The registry lists those as other outcomes. Nor does a group mean describe the full distribution of results or imply that every person in an arm had a result close to that average. The primary analysis is specifically framed as a non-inferiority comparison of the mean BCDVA outcome.

7. Results Posted in the Registry

• FINEVISION HP: mean 0.02 versus -0.03 on control; difference 0.05 (95% CI 0.03 to 0.06), standardized effect d = 0.52; z-test p = <0.001.

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.

Mean Photopic Monocular logMAR Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm for the First Operative Eyes.

• 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 errors.
• Result:
  • FINEVISION HP: mean 0.16 versus 0.34 on control; difference -0.18 (95% CI -0.20 to -0.16), standardized effect d = -1.51; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for FINEVISION HP than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The secondary outcomes broaden the assessment beyond the primary distance-acuity measure. The posted outcomes include intermediate visual acuity, cumulative and persistent adverse events compared with ISO Safety and Performance Endpoint rates, and visual disturbances assessed with the Quality of Vision questionnaire and supplemental questions. The registry lists three posted secondary outcome measures, while its record lists 10 outcome measures and 26 analyses overall.

The intermediate-acuity analysis reports lower mean logMAR for FINEVISION HP than for Control Product at 66 cm and labels the result as superiority, with p < 0.001. This result concerns intermediate acuity, not the primary distance-acuity measure. The direction of the scale is important: the registry states that lower logMAR represents better acuity. The secondary result therefore provides outcome-specific context alongside the primary non-inferiority analysis; it does not change what the primary endpoint measures.

The secondary results should not be read as a single global test of benefit or risk. They address different endpoints, have different measurement properties, and may involve different populations or analysis methods. The full results for all secondary measures are not reproduced in this narrative. In particular, the registry lists the QoV and safety outcomes, but that listing alone does not establish a favorable or unfavorable finding for those measures.

Unadjusted secondary results carry less weight because multiple outcomes and analyses create opportunities for chance findings. A small p-value from an individual test does not by itself account for the number of tests performed, and it does not establish clinical importance. The registry record does not report whether secondary analyses used a multiplicity adjustment or a prespecified testing hierarchy. These findings are best treated as supporting, outcome-specific evidence and interpreted together with their estimates, uncertainty, and analysis context rather than as independent confirmations of the primary result.

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

• Mean Photopic Monocular logMAR Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 cm for the First Operative Eyes.
• Number and Percentage of First Operative Eyes With Cumulative and Persistent Adverse Events at Month 12 (Visit 5) in Comparison to the ISO Safety and Performance Endpoint (SPE) Rates as Described in ISO 11979-7
• Evaluate Visual Disturbances Using the Quality of Vision (QoV) Questionnaire and QoV Supplemental Questions at Month 12 (Visit 5)

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: each analyzed eye has a logMAR measurement, and the arm results are expressed as means. A mean summarizes the central location of measurements, but does not show their full spread. The posted primary means are accompanied by standard errors. A standard error describes the uncertainty in an estimated mean; it is not the same as the range of participant-level results. The registry also reports a comparison between arms, which is the more direct summary for the study question.

What does non-inferiority test?

A non-inferiority analysis is designed to assess whether an investigational treatment is not unacceptably worse than a comparator by a prespecified amount. The allowed amount is called the non-inferiority margin. The margin is part of the interpretation: an estimate and its uncertainty need to be evaluated against that boundary. The registry identifies the primary reported analysis as non-inferiority, but the margin and its justification are not reported in the registry record. Consequently, the reported analysis can be described, but the margin-based decision cannot be reconstructed from the registry information alone.

The sponsor-reported primary analysis is a one-sided t-test of the mean difference. A t-test evaluates a contrast between group means relative to the uncertainty in that contrast, under assumptions appropriate to the analysis. The one-sided form reflects a directional question, which is common in non-inferiority testing. The registry reports the mean difference as 0.045, a 90% confidence interval, and p < 0.001. Those are the sponsor’s stated analysis results and should be kept distinct from an unadjusted recalculation.

What does the recalculation add?

The unadjusted recalculation uses the posted group means and standard errors to form a simple comparison. It gives a mean difference of 0.046 and a 95% confidence interval from 0.030 to 0.062, with p < 0.001. This is a descriptive cross-check based on the posted summary statistics, not a replacement for the sponsor’s non-inferiority analysis. It does not incorporate any adjustment or analysis details that are not represented in those summaries. In particular, it does not establish the non-inferiority margin or reproduce an unavailable protocol-level analysis.

A confidence interval gives a range of estimates compatible with the data and the method used to calculate it. Its width reflects precision: narrower intervals indicate less uncertainty about the estimated contrast, while wider intervals indicate more. The stated confidence level concerns the long-run behavior of the interval method under its assumptions; it is not a probability statement that the particular interval contains the true effect. The sponsor’s interval is 90%, while the simple recalculation is 95%, so they should not be compared as if they were generated by identical methods.

Why can variability matter?

Group means can be similar or different for several reasons, including a true difference and sampling variability. The standard error reflects uncertainty in a mean estimate and depends on the variability of the observations and the amount of information available. In general, greater dispersion in participant measurements makes a mean contrast less precise if other features remain unchanged. The registry posts standard errors for the arm means; it does not report the participant-level outcome distribution in the record summarized for this analysis.

Assumptions about the outcome distribution and analysis structure also matter. The registry’s reported method identifies a t-test but does not report detailed diagnostics, adjustments, or the full model specification. The primary outcome is defined for first operative eyes, which avoids treating both eyes as separate primary observations in the stated endpoint population. How observations with missing visit data were handled beyond the available-data population description is not reported in the registry record.

How should secondary p-values be viewed?

The registry posts multiple outcome measures and analyses, and the secondary outcomes cover different questions. Testing many outcomes creates more opportunities for apparently notable results to occur by chance when each is assessed separately. An unadjusted p-value addresses the individual analysis under its assumptions; it does not automatically account for the full family of outcomes. A multiplicity adjustment or a prespecified hierarchy can help manage that issue, but whether either was used for these secondary analyses is not reported in the registry record. The posted secondary findings therefore add context, but they should not be treated as having the same evidential role as the primary endpoint.

The secondary intermediate-acuity comparison is reported as a two-sided t-test and labeled superiority. The registry posts p < 0.001, but does not report a confidence interval for that analysis in the record. The simple recalculation of its mean contrast is descriptive and unadjusted. Safety and questionnaire outcomes use different kinds of information and require interpretation suited to their measurement and reporting. Results across these measures cannot be collapsed into a single conclusion about the overall experience of every participant.

11. Confidence Intervals and Precision

For the primary mean difference, the sponsor-reported estimate is 0.045, with a 90% confidence interval from 0.032 to 0.059. The unadjusted recalculation is 0.046, with a 95% confidence interval from 0.030 to 0.062. The interval endpoints describe uncertainty around the contrast under their respective methods. The different confidence levels and analysis methods mean these intervals are not interchangeable, even though their estimates are close.

Both posted intervals are on the positive side of zero. That conveys that, under the calculation methods used, the estimated primary contrast is positive rather than centered on no mean difference. It does not by itself answer the non-inferiority question, which depends on the margin. Because the margin is not reported in the registry record, the interval cannot be assessed against that boundary.

The interval width is a practical indication of precision. It does not reveal the spread of individual visual acuity measurements or guarantee that individual outcomes cluster around the group mean. The registry posts standard errors of 0.005 for FINEVISION HP and 0.006 for Control Product. Those are measures of uncertainty in the arm means, not standard deviations of participants’ results.

Precision also depends on the analyzed population and outcome availability. The primary endpoint is reported for first operative eyes with data available at the visit, with arm counts of 332 and 164. The registry does not provide enough detail to assess how missing measurements may have affected the estimates. The confidence intervals quantify sampling uncertainty according to the analysis, not uncertainty from unreported design choices, missing-data handling, or the relevance of the observed difference to clinical importance.

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 sample-size table and curve are planning illustrations based on the observed effect, not the trial’s original design calculation. The assumptions listed for these illustrations are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set to a stated fraction of the observed effect. For these continuous outcomes, the figures are participants per arm, not a total number across arms. The registry’s note about total event counts applies to time-to-event tables, not these continuous-outcome calculations.

The 80% power column gives the illustrative participants per arm for a design with an 80% chance of detecting the specified effect under the stated assumptions, if that effect were the true effect and the method’s assumptions held. The 90% power column gives the corresponding illustration for a 90% chance. These are planning concepts: power is a property of a proposed design under a chosen effect and assumptions, not a measure of how likely the observed result is true.

The rows consider planning for 100%, 75%, and 50% of the observed effect. For the primary outcome, the displayed participants per arm for 80% power are 59, 104, and 233, respectively; for 90% power they are 78, 139, and 312. Smaller effects need more participants to detect with the same power under otherwise unchanged assumptions. The planning figures are therefore sensitive to the effect chosen, and the observed effect can be an uncertain basis for future planning.

These values are not observed power. They do not describe the power achieved by the completed trial, and they do not show how many participants were actually required by its original design. The original sample-size justification and design assumptions are not reported in the registry record.

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 = 0.046; pooled standard deviation σ = 0.089.
2. n = 2 × (1.96 + 0.842)² × 0.089² / 0.046² = 58.2, rounded up to 59 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 <- 0.046                      # observed difference in means
sigma <- 0.0885868246754159                     # 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(4176965)
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 = 59 (80% power), 78 (90% power)
 75% of observed effect: n per arm = 104 (80% power), 139 (90% power)
 50% of observed effect: n per arm = 233 (80% power), 312 (90% power)
power.t.test: 59.2 
Simulated power at n = 59 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-reported primary analysis is a one-sided t-test for non-inferiority. It gives a mean difference of 0.045, a 90% confidence interval from 0.032 to 0.059, and p < 0.001. This is the analysis tied to the stated primary non-inferiority question and should be distinguished from the simple recalculation based on posted group summary statistics.

The recalculation gives a mean difference of 0.046, a 95% confidence interval from 0.030 to 0.062, and p < 0.001. It is an unadjusted comparison using the posted means and standard errors. Its purpose is to provide a transparent numerical cross-check, not to reproduce every feature of the sponsor’s analysis. The two estimates are close, but their confidence intervals use different confidence levels and their analyses are not identical.

The registry record does not flag a discrepancy between the posted statistics and the recalculation. Even so, the sponsor analysis remains the relevant reported test for the non-inferiority objective. The non-inferiority margin, its rationale, and further details of the analysis plan are not reported in the registry record. Without those details, the sponsor result can be accurately described, but its margin-based interpretation cannot be independently audited from the posted information alone.

15. Multiplicity, Missing Data and Analysis Populations

The registry reports multiple outcomes and analyses: 10 outcome measures and 26 analyses, with three secondary outcome measures posted. When several endpoints or comparisons are examined, the chance of obtaining at least one apparently notable result by chance can increase if each analysis is judged separately. This is the multiplicity problem. It is particularly relevant when interpreting secondary p-values as a group, rather than as isolated tests.

Possible approaches include adjusting significance thresholds, controlling a defined family of tests, or specifying an order in which hypotheses will be tested. These approaches require a clear plan identifying which outcomes and analyses belong together and how decisions are made. Whether such a plan or adjustment was used is not reported in the registry record. The secondary p-values should therefore be treated as individual reported results, not as evidence that has necessarily been corrected for all analyses.

The registry defines the primary analysis population as the All-Implanted Analysis Set for first operative eyes with data available at the visit. The arm counts are 332 and 164 for the primary outcome. This description identifies the population contributing available measurements, but does not explain the handling of missing measurements, the reasons for missingness, or whether any sensitivity analyses assessed the impact of missing data. Those details are not reported in the registry record.

The registry also does not report the full statistical analysis plan, the original sample-size justification, or the non-inferiority margin. The margin is essential for interpreting the primary test as a margin-based non-inferiority assessment. Detailed model specifications, outcome-distribution checks, and any prespecified adjustments beyond the reported t-test are not reported in the registry record. These omissions limit independent assessment of the analysis choices and the robustness of conclusions to alternative assumptions.

These gaps do not invalidate the posted numerical results, but they define what can be concluded from the registry entry alone. The estimates and p-values describe the reported analyses; they do not supply the missing design rationale, missing-data strategy, or multiplicity framework.

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 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: retinal detachment (0.9%), vitrectomy (0.9%), vitreous detachment (0.6%), macular hole (0.6%), anaemia (0.6%).

The registry posts serious adverse event counts separately for first operative eyes, second eyes, and systemic events, and separates the FINEVISION HP and Alcon AcrySof SN60AT groups. For first eyes, the serious adverse event counts are 8 among 332 at risk for FINEVISION HP and 2 among 164 at risk for the monofocal control. For second eyes, the counts are 2 among 329 at risk and 1 among 164 at risk, respectively. Systemic serious adverse event counts are 11 among 332 at risk in the FINEVISION HP group and 9 among 164 at risk in the control group.

The registry reports one death in the FINEVISION HP systemic group and two in the control systemic group. It also lists serious-event terms including retinal detachment, vitrectomy, vitreous detachment, macular hole, anaemia, and myocardial infarction, with the posted percentages ranging from 0.6% to 0.9%. These terms and counts are descriptive registry reports; they do not establish that an event was caused by a device or that the groups differ in risk.

These counts should be read with their stated at-risk groups and event categories. The registry does not provide enough detail to infer comparative risk, event timing, severity beyond the serious-event classification, or causal attribution. Safety interpretation also requires attention to the amount of follow-up and the way events were collected, details that are not reported in the registry record.

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

The results describe mean visual acuity outcomes in the analyzed first operative eyes at the specified follow-up, along with other posted outcomes. The registry’s primary result is a non-inferiority analysis of mean photopic monocular BCDVA at 4 meters. Its reported mean difference is 0.045 with a 90% confidence interval from 0.032 to 0.059 and p < 0.001. The simple recalculation is close in estimate, but it is not the sponsor’s non-inferiority test.

A statistically significant result is not equivalent to a clinically important difference. The registry does not report a threshold for a clinically meaningful change in this measure, and the non-inferiority margin is not reported in the registry record. The scale’s direction is stated: lower or negative logMAR values represent better acuity. The arm means therefore need to be understood in that scale context, and a mean contrast does not describe the outcome of every participant.

The primary endpoint addresses corrected distance acuity under specified testing conditions. It does not settle questions about intermediate or near vision, visual disturbances, satisfaction, or safety. The secondary intermediate-acuity analysis reports a different visual outcome, while the other listed secondary outcomes address adverse events and visual disturbances. These outcomes add context but do not expand the primary endpoint into a complete account of visual function.

The registry describes a randomized, double-masked trial, but the record does not include every detail needed to assess implementation, missing-data handling, or analysis choices. The posted estimates apply to the reported populations, devices, and timeframes; they should not be generalized automatically beyond those circumstances. The event counts are descriptive and do not establish causation or comparative safety.

Overall, the posted statistics support a precise description of the trial’s measured results, but several elements needed for a full independent appraisal—including the non-inferiority margin and its rationale—are not reported in the registry record. The results should be interpreted within that boundary rather than as a universal statement about all visual outcomes or all recipients of either lens.

18. Why This Trial Matters Statistically

This trial illustrates why the statistical question must match the study objective. The primary endpoint is framed as a non-inferiority comparison, not simply as a search for any difference between means. A one-sided test and its confidence interval are meaningful in relation to a specified non-inferiority margin. Because that margin is not reported in the registry record, the reported test can be described but not fully reconstructed as a margin-based decision from the entry alone.

It also demonstrates the difference between a sponsor-reported analysis and a simple recalculation from summary statistics. The recalculated mean difference is close to the reported estimate, but the methods and confidence levels differ. A close numerical estimate does not make the calculations interchangeable: the sponsor’s analysis addresses the stated primary objective, while the recalculation is an unadjusted check based on posted means and standard errors.

The trial also has several kinds of outcomes. Distance acuity, intermediate acuity, visual disturbances, and adverse events answer different questions. A favorable-looking result on one measure cannot be assumed to characterize all other dimensions, and multiple secondary analyses raise multiplicity concerns. Reporting the outcome domain and its scale is essential to interpreting direction and meaning.

Finally, the registry makes visible the distinction between enrollment and outcome analysis. It reports 539 enrolled participants and separate available-data counts for the primary endpoint. Those figures do not by themselves explain missing outcome data or the original design rationale. Clear reporting of analysis populations, uncertainty, missing-data handling, and multiplicity methods is central to independent statistical appraisal of clinical investigations.

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 or its justification. That omission limits interpretation of the primary analysis because the margin defines what degree of possible inferiority the study was designed to exclude. The full original statistical analysis plan and sample-size justification are also not reported, so the planned assumptions and analysis choices cannot be checked against the posted results.

The primary outcome population is described as first operative eyes with data available at the visit. The record gives arm counts of 332 and 164, but missing-data reasons, handling methods, and sensitivity analyses are not reported in the registry record. The enrollment figure of 539 does not explain how participants contributed to each outcome analysis.

The available summary statistics do not show the full distribution of individual acuity measurements. The means and standard errors support a group-level comparison, but they do not indicate the range of participant outcomes or the proportion meeting any particular threshold. The registry does not report a clinical-importance threshold for the logMAR contrast.

There are multiple outcome measures and analyses, but the record does not report whether secondary tests were adjusted for multiplicity or tested within a hierarchy. The secondary results therefore require caution as a family of findings. Further details of randomization and masking implementation are also not reported in the registry record.

Safety figures are posted as counts within at-risk groups, but the information does not establish causality or permit a comprehensive comparative-risk analysis. Event timing, adjudication details, and additional follow-up context are not reported in the registry record. These limitations concern what can be independently assessed from the registry entry; they do not imply that unreported procedures were absent.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Investigation of the Safety and Effectiveness of a Trifocal IOL — NCT04176965.
• Registry record last updated 2025-01-29; status last verified 2025-01.
• Results first posted 2025-01-29.
• 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

NCT04176965 is a completed, randomized, double-masked, parallel-group clinical investigation comparing FINEVISION HP trifocal IOL with Alcon AcrySof SN60AT monofocal IOL. The registry reports 539 enrolled participants and a primary endpoint of mean photopic monocular logMAR BCDVA at 4 meters in first operative eyes, measured 150-180 days after first-eye surgery.

The sponsor-reported one-sided non-inferiority analysis gives a mean difference of 0.045, a 90% confidence interval from 0.032 to 0.059, and p < 0.001. The unadjusted recalculation gives 0.046, a 95% confidence interval from 0.030 to 0.062, and p < 0.001. The non-inferiority margin, original sample-size justification, and detailed missing-data and multiplicity methods are not reported in the registry record.

Posted secondary outcomes address intermediate acuity, adverse events, and visual disturbances. Safety counts are descriptive and should not be interpreted as causal comparisons.