A Clinical Study Comparing Postoperative Outcomes Between the TECNIS Intraocular Lens.: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Clinical Study Comparing Postoperative Outcomes Between the TECNIS Intraocular Lens. (NCT05396599), a randomized na study. The primary outcome is Rotational Stability of IOL.

2. Clinical Question

In practical terms, the study is concerned with whether the implanted lens remains rotationally stable during the stated postoperative interval. Rotational stability is relevant to toric lenses because the intended optical correction is tied to lens orientation. The endpoint as described is a status at a specified visit, rather than a time-to-event measure or a continuous measurement of the amount of rotation. The registry record does not define the threshold used to classify an eye as stable, explain how rotation was assessed, or specify whether the analysis counted eyes or participants. Those details matter for interpreting what the outcome represents. The clinical question is therefore identifiable at a broad level, while its operational definition and the intended comparison between lenses remain incompletely described.

3. Trial Design

The registry record describes a prospective, multi-center, randomized, double-masked, parallel study with three arms. It compares two test lenses, TECNIS Eyhance Toric II IOL and TECNIS Synergy Toric II, with TECNIS Toric 1-Piece IOL as the control. The condition is cataract, and all three interventions are listed as devices. The registry gives an enrollment of 35. It does not explain whether that figure represents the number enrolled, randomized, or included in a particular analysis.

The reported study start date is 2022-06-30, and the primary completion date is 2023-04-07. The status is TERMINATED. The reason for termination is not reported in the registry record. The phase is listed as NA, so the record does not identify a phase designation. The sponsor is Johnson & Johnson Surgical Vision, Inc.

The primary outcome is rotational stability of the intraocular lens at 1 month. The outcome population is described as all eyes with available data at that visit. The posted outcome groups list Test Lens 1 with n of 11, Test Lens 2 with n of 13, and Control Lens with n of 10. The safety groups list different numbers at risk for the control lens than the primary outcome group. The registry does not explain these differences or provide a participant-flow account to reconcile them with the enrollment figure.

Although randomization and masking are stated, the sequence-generation method, allocation concealment, masking roles, and implementation details are not reported in the registry record. The planned sample-size justification, target enrollment by arm, interim analyses, and stopping rules are also not reported in the registry record. The parallel design indicates that participants were assigned to one of the lens groups, but further details about the unit of randomization and the handling of eyes within participants are not given. These omissions limit assessment of how the design was conducted and what population the posted group summaries represent.

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 37 subjects were consented. Out of 37 subjects, 2 subjects were screen failures and 35 subjects were enrolled and completed the study. Out of 35 subjects, 11 subjects were treated with Test Lens 1 (TECNIS Eyhance Toric II IOL), 13 subjects were treated with Test Lens 2 (TECNIS Synergy Toric II IOL), and 11 subjects were treated with control lens (TECNIS Toric 1-Piece IOL).

Overall Study

Analysis population for the primary outcome, as defined in the registry: All eyes with available data at 1 month 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.

6. Primary Endpoint

The registry lists the primary outcome as Rotational Stability of IOL, measured over 1 month.

The primary endpoint is titled “Rotational Stability of IOL” and has a timeframe of 1 month. Its description says it is the percentage of eyes with rotational stability at the postoperative 1 month visit. The population is described as all eyes with available data at that visit. This is a binary-status concept: each assessed eye would be classified as stable or not stable under a study definition. However, the registry does not report the classification threshold, the assessment procedure, or whether the assessment was performed by masked evaluators.

The reason for using this type of endpoint is that orientation matters for toric intraocular lenses. A lens that changes orientation may not maintain its intended astigmatism correction. This is a general explanation of the clinical rationale, not a claim about outcomes in this study. A measure at a specified visit can provide a snapshot of the proportion or number of eyes meeting a stability criterion, but it does not on its own describe how much rotation occurred, when it occurred, or whether it persisted.

There is a reporting ambiguity. The endpoint description refers to a percentage, while the listed unit is eyes and the parameter is a count. The outcome values are 19, 22, and 16, and the associated group sizes are 11, 13, and 10. Because the record does not resolve the unit-description mismatch, the values should not be converted or treated as percentages. The endpoint is also not accompanied by confidence intervals or an explicit comparison analysis. Thus, the registry identifies the intended outcome but does not provide enough detail to establish the precise estimand or the uncertainty around a lens-to-lens difference.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry record identifies a randomized, double-masked, parallel design with three arms. Randomization is intended, in general, to make treatment groups comparable with respect to both measured and unmeasured characteristics, apart from chance differences. Masking is intended to reduce the influence of knowledge about treatment assignment on care, measurement, or reporting. These are general purposes of the design features. The record does not report how randomization was generated or concealed, who was masked, or how masking was maintained, so those aspects cannot be evaluated for this study.

What does the posted outcome summarize?

The primary endpoint is rotational stability at 1 month, described as the percentage of eyes that meet a stability criterion. The outcome records list values of 19, 22, and 16 for the three lens groups, with group sizes of 11, 13, and 10. A count endpoint ordinarily summarizes how many observed units meet a stated condition. A percentage ordinarily expresses that count relative to a denominator. Here, the registry lists the unit as eyes and the parameter as a count, while the description uses percentage. This inconsistency is important: a reader cannot select one interpretation without additional documentation. The record does not define the threshold or state how a percentage was calculated.

Why does the analysis unit matter?

The endpoint is expressed in eyes, and its population refers to all eyes with available data. In general, if a participant can contribute more than one eye, measurements from the same participant may be related rather than statistically independent. An analysis that treats correlated eyes as independent can make uncertainty appear smaller than it is. The registry record does not say whether one or both eyes per participant could contribute, how randomization related to the eye or participant, or whether any within-participant dependence was handled. This is a general statistical concern, not a finding that such dependence occurred in this study.

For a binary endpoint, a comparison might be expressed as a difference in proportions, a ratio, or another contrast, depending on the analysis plan. These approaches answer related but not identical questions. A difference describes an absolute separation between groups, while a ratio describes relative separation. The registry does not report which contrast was planned, and the count-versus-percentage ambiguity prevents a reliable reconstruction from the posted summaries. No new contrast should be calculated from the group values.

What do uncertainty measures add?

A point estimate gives a single summary, while a confidence interval communicates uncertainty around an estimate under a specified statistical model. In general, intervals that are wide indicate that the available data are compatible with a broad range of effects; narrow intervals indicate greater precision, subject to the validity of the analysis assumptions. A p-value, when reported, addresses compatibility with a specified null model and is not a measure of the size or clinical importance of an effect. The registry record posts no confidence interval or p-value for the primary outcome and no analysis estimate. Precision and statistical evidence for a between-lens difference therefore cannot be assessed from the listed values alone.

Small groups can yield imprecise estimates, particularly for outcomes that occur in a limited number of eyes. This is a general principle and should not be turned into a numerical precision claim without an analysis. The enrollment figure of 35 does not itself establish that the study had adequate power for the primary endpoint. The registry does not report a sample-size justification, the effect size used in planning, or a target power. It is therefore not possible to assess whether the study was designed to answer the primary question with a particular level of precision.

How should planning illustrations be read?

Any sample-size illustration based on the observed effect is a planning exercise rather than a report of the study’s design or a measure of observed power. In general, such an illustration asks how many participants per arm might be needed under stated assumptions to detect a chosen fraction of an observed effect. The registry’s stated illustration assumptions include a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They do not show that this trial used those assumptions in its planning. The record also indicates that values were missing or not estimable for a two-arm comparison for this count-other endpoint. Thus, a planning illustration should not be treated as a study result or as evidence that the trial had a particular probability of detecting an effect.

The stated planning framework refers to participants per arm for non-time-to-event outcomes. That terminology does not settle whether the primary endpoint’s analysis unit is an eye or a participant, which remains unclear in the registry. More generally, power calculations depend on an outcome definition, a comparison, assumptions about variability or event rates, and a target effect. Because the record does not provide the study’s own design justification, these planning conventions should be kept separate from the observed trial data.

What can be concluded from descriptive summaries?

Descriptive group values can show what was posted for each arm, but they do not substitute for a planned analysis. A treatment comparison should account for the design, define the analysis population, specify how missing observations are handled, and estimate uncertainty. With three arms, there may be several scientifically relevant contrasts. If multiple contrasts are tested, the interpretation of statistical evidence can be affected by multiplicity. The record does not report a comparison strategy or an adjustment approach. The absence of an analysis in the registry means these methods cannot be reviewed, and no inferential conclusion should be added to the descriptive results.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists one primary outcome measure and zero analyses. It does not list secondary posted outcomes. With three treatment arms, more than one pairwise comparison could be considered, but the record does not identify a planned comparison hierarchy, a primary contrast, or a multiplicity adjustment. Multiplicity is a general issue that arises when several hypotheses are tested: the chance of at least one apparently notable result can increase unless the analysis plan accounts for the set of tests. No claim can be made about how that issue was handled in this study because an analysis plan is not reported in the registry record.

The primary outcome population is described as all eyes with available data at the 1 month visit. This is an available-data definition, not a full account of how missing observations were managed. The record does not state how many eligible eyes lacked 1 month data, why data might be absent, whether any imputation was used, or whether sensitivity analyses were performed. Missingness can matter when the likelihood of having an observed outcome is related to treatment assignment or the outcome itself. That is a general statistical concern; the registry does not provide evidence about the pattern or cause of missingness in this study.

The registry does not describe an intention-to-treat population, a per-protocol population, or another prespecified analysis population. It also does not provide participant flow from enrollment through randomization, follow-up, and outcome assessment. The control group’s primary outcome size is 10, while the safety record lists 11 at risk. The difference is not explained. These limitations prevent a clear account of which participants or eyes contributed to each result and how the posted groups relate to the randomized population.

11. 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.

The adverse-event summary lists zero serious adverse events for Test Lens 1, Test Lens 2, and the Control Lens. The corresponding numbers at risk are 11, 13, and 11. The same groups list zero other adverse events, with those same numbers at risk, and zero deaths in each group. These are the registry’s posted safety figures. They describe what is recorded in this entry, not a guarantee that no event occurred outside the recorded observation or reporting process.

The safety denominators do not fully match the primary outcome group sizes: the control group has 11 at risk in the safety summary and n of 10 in the primary endpoint summary. The registry record does not explain the difference. Safety and efficacy summaries can use different populations or observation rules, but that is a general possibility and cannot be assumed to explain this case. The record also does not provide adverse-event definitions, collection procedures, observation duration, or a breakdown of event terms; the list of top serious terms is empty.

Zero recorded events in these groups should be read cautiously. With limited numbers at risk, the summary alone cannot establish the frequency of uncommon events or precisely characterize safety. It also does not establish that the lenses have equivalent safety profiles. The registry’s figures are descriptive counts within the record, without comparative estimates or uncertainty intervals.

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

The registry record identifies a randomized comparison of two test lenses with a control lens and reports values for rotational stability at 1 month. Those values are 19, 22, and 16, with listed outcome group sizes of 11, 13, and 10. The endpoint description calls the result a percentage, but its unit and parameter indicate eyes and a count. Since the record does not resolve that discrepancy, the values should be reported as they appear rather than interpreted as percentages or used to derive a comparison.

The record does not post an inferential analysis for the primary endpoint. It provides no effect estimate, confidence interval, or p-value. Therefore, it does not show how precisely any difference between lens groups is estimated, whether an observed separation is compatible with chance variation, or how large a difference might be under a specified comparison. Descriptive values alone cannot establish that the lenses differ or are similar. They also cannot establish that an observed pattern is clinically important.

The study’s TERMINATED status is reported, but the reason for termination is not reported in the registry record. The record does not explain whether termination affected enrollment, follow-up, or endpoint availability. Enrollment is listed as 35, while the outcome and safety summaries use group sizes that do not all align. Without a flow account, the relation among enrollment, treatment assignment, follow-up, and analyzed observations remains unclear.

The safety summary reports zero serious adverse events, zero other adverse events, and zero deaths in the listed groups. Those figures describe the posted record and should not be read as proof that risks are absent. The size of the groups and lack of event-collection details limit what can be learned about uncommon harms or relative safety.

In general, a trial result is most informative when the outcome definition, analysis population, comparison, missing-data approach, and uncertainty are all clear. Several of those elements are not reported. The registry supports a description of the study and its posted values, but not a definitive statistical conclusion about comparative lens performance.

13. Why This Trial Matters Statistically

This study illustrates why a clearly specified endpoint is essential to interpreting a clinical trial. The primary question is framed as a percentage of eyes with rotational stability, but the registry labels the outcome as a count in eyes. That difference is not merely editorial: counts and percentages have different interpretations and require different denominators. Without a definition that reconciles the labels, readers cannot confidently compare the reported values or assess what they represent.

The record also demonstrates the importance of distinguishing descriptive data from an analysis. Three arm-level values can suggest a pattern, but they do not quantify the uncertainty of a comparison. A statistical estimate with an appropriate confidence interval would help show how much the data constrain a plausible contrast. The registry lists zero analyses, so the posted figures do not support a claim about statistical evidence or precision. This distinction is relevant to clinical readers who may otherwise infer more from the numerical ordering than the record can establish.

Another statistical issue is the relationship between the analysis unit and the study population. The outcome is expressed in eyes, while enrollment is reported at the study level. If more than one eye could contribute for an individual, within-person correlation could matter. The record does not specify how many eyes per participant were included or how that structure was addressed. This is a general design consideration that becomes especially important when eye-level endpoints are analyzed.

Finally, the differences between the primary outcome and safety group sizes emphasize why participant flow and analysis populations matter. A reader needs to know who was eligible, randomized, followed, and assessed to understand whether each outcome summarizes the same set of participants or eyes. The registry does not supply that explanation. These issues do not make the posted results meaningless; they define their limits and show what information would be needed for a transparent statistical interpretation.

14. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

Several trial-specific limitations restrict interpretation. The primary endpoint is described as a percentage but is classified with the unit eyes and a count parameter. The record does not clarify this discrepancy, define the stability threshold, or describe the measurement method. As a result, the posted values cannot be assigned an unambiguous statistical meaning. The outcome population includes eyes with available data at 1 month, but the record does not report missing outcome counts or explain how missingness was handled.

The registry lists an enrollment of 35, but does not provide a participant-flow account or explain how enrollment relates to the posted group sizes. The primary outcome groups list n values of 11, 13, and 10; the safety groups list 11, 13, and 11 at risk. The reason for the control-group difference is not reported in the registry record. The record also does not state whether the unit of randomization was the participant or eye, whether one or both eyes could contribute, or how correlated eye-level measurements were handled.

No inferential analysis is posted for the primary outcome. There are no reported effect estimates, confidence intervals, or p-values, and the registry does not identify the intended contrasts among the three arms. A sample-size justification, target power, interim-analysis plan, and analysis plan are not reported in the registry record. The termination reason is also not reported. These omissions leave uncertainty about study conduct, precision, and the extent to which the recorded endpoint data represent the randomized groups.

The adverse-event summary records zero events across the listed groups, but does not provide detailed definitions, collection procedures, or event follow-up information. The small listed groups also limit the ability of descriptive counts to characterize uncommon outcomes. These are limits of what can be inferred from this registry entry, not evidence that unreported events or analyses did or did not occur.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: A Clinical Study Comparing Postoperative Outcomes Between the TECNIS Intraocular Lens. — NCT05396599.
• Registry record last updated 2024-06-04; status last verified 2024-05.
• Results first posted 2024-06-04.
• 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.

18. Record Summary

The registry record describes a prospective, multi-center, randomized, double-masked, parallel, three-arm study of intraocular lenses for cataract. The test lenses are TECNIS Eyhance Toric II IOL and TECNIS Synergy Toric II; the comparator is TECNIS Toric 1-Piece IOL. Enrollment is listed as 35, the status is TERMINATED, and the reported study dates are 2022-06-30 and 2023-04-07 for start and primary completion.

The primary endpoint is rotational stability at postoperative 1 month among eyes with available data. The posted values are 19, 22, and 16, with group sizes of 11, 13, and 10. The endpoint description refers to a percentage, while its unit and parameter indicate a count of eyes. The registry lists zero analyses and posts no inferential comparison. The adverse-event summary records zero serious adverse events, zero other adverse events, and zero deaths in each listed group. The termination reason, endpoint definition details, missing-data handling, and analysis plan are not reported in the registry record.