Patient Reported Satisfaction With Contoura LASIK Utilizing the Phorcides Analytic Software: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Patient Reported Satisfaction With Contoura LASIK Utilizing the Phorcides Analytic Software (NCT05848817), a registered phase not stated study. The primary outcome is Subject Satisfaction.

2. Clinical Question

3. Trial Design

The registry record describes a completed study sponsored by Mann Eye Institute. It lists myopia as the condition, an enrollment of 50, and Contoura LASIK as the sole intervention. The intervention description specifies Phorcides Planned Contoura LASIK. The listed primary outcome is Subject Satisfaction, measured at 3 Months Postoperative. A secondary outcome concerns the number of eyes with postoperative spherical equivalent within +/- 0.50 D.

The record does not describe a comparator group or state how participants were allocated. It therefore does not establish a randomized comparison or a like-for-like control comparison. The number enrolled should not be assumed to be the number with available primary-outcome data: the number assessed at the endpoint and the handling of missing responses are not reported in the registry record.

The study is marked COMPLETED, with a start date of 2023-05-19 and a primary completion date of 2024-08-15. Completion status indicates the registered study reached its recorded completion status; it does not, by itself, provide the primary outcome result or confirm how many participants contributed to each analysis. Although the record lists 4 outcome measures, it reports 0 analyses. The protocol details, including any statistical analysis plan and sample-size justification, are not reported in the registry record. The reported enrollment should therefore be read as a study descriptor, not as evidence that a particular target was statistically justified or achieved.

4. Participant Flow and Accounting

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

Overall Study

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 Subject Satisfaction, measured over 3 Months Postoperative.

The primary endpoint is participant satisfaction with vision after surgery, assessed at 3 Months Postoperative. The registry defines satisfaction as answering Completely Satisfied or Very Satisfied to PROWL Questionnaire Question #1. It describes the intended summary as a percentage of subjects, while the recorded outcome parameter is a participant count. The registry record does not report the count or percentage of participants meeting the satisfaction definition.

Patient-reported satisfaction captures an aspect of experience that is not interchangeable with a clinical measurement such as refractive accuracy. A participant’s response to a questionnaire can summarize their own appraisal of vision, whereas an eye-based measurement describes a different outcome. The secondary endpoint concerning postoperative spherical equivalent within +/- 0.50 D addresses refractive results, not satisfaction itself. Neither measure alone answers every question about outcomes after surgery.

General statistical interpretation: a clearly defined binary endpoint separates responses that meet the criterion from those that do not. To estimate a percentage, the number meeting the criterion and the relevant number with outcome data are needed. The registry record does not state those outcome counts, the denominator used, or how incomplete questionnaire responses were handled. Consequently, it is not possible to assess the observed satisfaction proportion or its precision from the registry information alone.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is binary at the participant level: a response either meets the registered satisfaction definition or it does not. The registry describes the intended outcome as a percentage of subjects who answer Completely Satisfied or Very Satisfied to PROWL Questionnaire Question #1. It records the outcome parameter as a participant count. These descriptions point to a count of qualifying responses as the underlying data and a percentage as the intended summary. However, neither the count nor the percentage is reported in the registry record.

What does a binary outcome summarize?

General statistical explanation: a binary outcome classifies each assessed participant into one of two categories for a specified endpoint. A count communicates how many participants met the criterion; a percentage relates that count to the number assessed. The denominator is essential because the same count can imply different percentages when the assessed groups differ in size. Here, the enrolled total is 50, but the registry record does not report the number who completed Question #1 or the denominator used for the endpoint. Enrollment must therefore not be substituted for the analysis denominator.

What would uncertainty measures add?

General statistical explanation: a confidence interval gives a range of values compatible with the observed data and the statistical method, while reflecting sampling uncertainty. A narrow interval indicates greater precision than a wide interval, all else equal. It does not account automatically for every source of uncertainty, such as selection, measurement, or missing-data concerns. The registry record does not report a confidence interval or enough outcome information to assess one. No statement about precision can be made from the enrollment figure alone.

How should the planning assumptions be understood?

The record describes sample-size illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and a specified fraction of the observed effect to detect. These are planning assumptions for illustrations, not a description of the trial's own design. In particular, the registry lists one intervention group and no comparator, and does not state allocation. The illustrations therefore should not be read as a report of the actual study structure or as evidence about the study’s observed statistical power. The study’s own sample-size justification is not reported in the registry record.

General statistical explanation: a sample-size calculation depends on its assumptions, including the effect size targeted, the significance level, the allocation structure, and the method used. Changing an assumed effect or design changes the planning result. A planning illustration can show how hypothetical design choices relate to participant requirements, but it is not an observed result and does not establish whether a completed study had adequate precision. The registry information does not give a numerical effect estimate for satisfaction, so the observed endpoint result cannot be evaluated alongside those planning assumptions.

What can be said about analyses?

The registry lists 0 analyses. It does not report an analysis model, an adjustment strategy, a confidence-interval method, or a prespecified handling of missing responses. No statistical analysis plan is described in the registry record. These omissions mean that the exact procedure used to turn questionnaire responses into a reported estimate cannot be assessed from the registry record. The record also does not report interim analyses or a sample-size justification; their absence from the record is not evidence that a particular procedure was or was not used outside the posted information.

General statistical explanation: if participants have missing endpoint responses, analysis choices can affect both the number analyzed and the interpretation of a percentage. A complete-case summary would use participants with observed responses; other methods may make different assumptions. Without reporting the endpoint denominator and missing-data approach, readers cannot determine which interpretation applies. The distinction between the enrolled total and the number analyzed is therefore important.

The secondary outcome is expressed as a number of eyes within a stated refractive range, while the primary outcome concerns participants’ questionnaire responses. These outcomes have different units and answer different questions. A participant may contribute more than one eye to an eye-based outcome, so the unit of analysis and any handling of within-participant dependence would matter for statistical inference. The registry record does not report the analysis details for this secondary outcome. No unreported method or result should be inferred from its description.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Contoura LASIK")
n      <- c(50)
events <- c(50)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Contoura LASIK  50  50  100.0  92.9  100.0  92.9  100.0  93.0  100.0

11. Multiplicity, Missing Data and Analysis Populations

The registry record lists 4 outcome measures and 0 analyses. It identifies Subject Satisfaction as the primary outcome and lists a secondary outcome concerning the number of eyes with postoperative spherical equivalent within +/- 0.50 D. The registry information does not describe the other outcome measures in detail here, nor does it explain how the outcomes were prioritized or analyzed together.

Multiplicity arises when several outcomes or statistical tests are considered. General statistical explanation: examining multiple results can increase the chance that at least one appears noteworthy by chance, depending on the tests and analysis strategy. Common approaches include prespecifying a primary endpoint, adjusting inference, or treating secondary outcomes as exploratory. The registry record does not report a multiplicity strategy, so it is not possible to assess whether or how any such approach was used. No claim about adjusted or unadjusted inference can be made.

The registry record also does not report the number of participants with primary-endpoint data, the amount or reasons for missing data, or how missing questionnaire responses were handled. It does not describe the analysis population or whether participants were included according to a prespecified rule. The enrollment of 50 should not be assumed to equal the number analyzed for satisfaction. These details affect the denominator and interpretation of any percentage, but the numerical primary result and its denominator are not reported in the registry record.

The record does not describe interim analyses, an analysis plan, or a sample-size justification. Their status is therefore not reported in the registry record. Such omissions do not establish that analyses were conducted improperly; they limit what can be verified from the posted registry information. The registered completion status does not resolve these questions about analysis or reporting.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The adverse-event record lists 50 participants at risk in the Contoura LASIK group, 0 serious events, 0 other events, and 0 deaths. No serious adverse-event terms are listed. These are the safety figures recorded for this group; they are not measures of the primary satisfaction endpoint.

General statistical explanation: an observed count of zero means that no event was recorded in the specified category for the listed group in the registry record. It does not establish that the underlying event risk is zero, nor does it show that every possible event was captured or reported. Interpreting a count also depends on the observation period, event definitions, and completeness of safety follow-up. The adverse-event record does not provide additional detail on those matters.

The 50 participants at risk should not be assumed to be the number with complete safety follow-up unless the record says so. The registry does not provide further safety analysis, uncertainty estimates, or a comparator group. Without a comparator, these counts do not support a comparative safety conclusion. They describe the recorded events in the listed intervention group only and should not be read as proof of the presence or absence of broader risks.

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

The registry record defines a clinically relevant patient-reported question: whether subjects were Completely Satisfied or Very Satisfied with vision after Phorcides Planned Contoura LASIK. It identifies the instrument item and the assessment time point, 3 Months Postoperative. That specificity helps clarify what the primary outcome was intended to represent. The record does not report the numerical response, however, so it does not show what proportion met the definition or how precisely that proportion was estimated.

The study is marked COMPLETED and reports enrollment of 50, but neither fact supplies the missing outcome result. Completion status does not mean that the primary endpoint is posted, and enrollment does not reveal how many participants answered the questionnaire. The record also lists a separate refractive outcome, but its numerical result is not reported in the registry record. Satisfaction and refractive accuracy are distinct measures and should not be treated as interchangeable.

The study description does not include a comparator or a stated allocation method. Its registry record therefore does not establish a controlled comparison from which to estimate a difference between groups. Even a reported proportion from a single group would describe that group at its assessment point; by itself, it would not show how a different intervention would perform or establish that the intervention caused the observed responses.

General statistical explanation: results are more informative when they include an estimate, its denominator, and an uncertainty measure, alongside a clear description of the population and analysis. Those elements allow readers to distinguish the observed data from the uncertainty around them. Here, the primary estimate, denominator, and uncertainty are not reported in the registry record. The appropriate interpretation is therefore limited: the registry specifies an intended satisfaction outcome and study group, but it does not provide enough outcome information to judge the observed satisfaction level or its precision. This is not evidence that satisfaction was high, low, or unchanged.

14. Why This Trial Matters Statistically

This study illustrates why a registry description and a numerical result answer different questions. The record identifies the endpoint, its response threshold, and its assessment time point. Those details allow readers to understand what was intended to be counted: participants meeting a defined satisfaction criterion at 3 Months Postoperative. Yet the record does not report the number or percentage meeting that criterion. Clear endpoint definitions are important, but they do not substitute for outcome data.

The study also highlights the importance of distinguishing participants enrolled from participants analyzed. Enrollment is 50, but the registry record does not report the primary-outcome denominator or missing-response handling. Without those details, a reader cannot determine how complete the questionnaire data were or what population a reported percentage would represent. This distinction is relevant whenever outcomes depend on participant responses.

Another statistical point is the difference between an observed single-group outcome and a comparative effect. The registry lists one intervention and no comparator, and allocation is not stated. As a result, the record does not support a like-for-like treatment comparison. A satisfaction result, if posted, would describe reported responses in the group rather than isolate the contribution of the intervention relative to a control.

Finally, the record lists multiple outcome measures but 0 analyses, and it does not report a multiplicity strategy or a statistical analysis plan. These omissions constrain assessment of how results were selected, analyzed, and interpreted. The case is a reminder that transparent reporting needs outcome values, denominators, analysis methods, and appropriate context—not only a completed status and a clearly worded endpoint.

15. Limitations

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

The main limitation for interpreting this trial from the registry record is that the numerical primary outcome is not reported. The primary endpoint is defined as satisfaction with vision, but there is no count, percentage, denominator, or uncertainty estimate. The record also does not report a numerical result for the listed secondary outcome concerning postoperative spherical equivalent within +/- 0.50 D. Consequently, the posted information does not permit evaluation of the observed endpoint values.

The registry describes one intervention group and no comparator, and allocation is not stated. This limits the interpretation to a description of the group rather than a controlled estimate of a difference. Participant and procedural characteristics beyond the condition and intervention description are not reported in the registry record. The eligibility criteria and details of the enrolled population are also not described in the information available.

The number enrolled is 50, but the number contributing to each outcome is not reported. The record does not explain missing questionnaire responses, follow-up completeness, analysis populations, or whether outcome data were excluded. It does not describe how the participant-level satisfaction endpoint or eye-level secondary outcome was statistically analyzed. No confidence intervals, adjustment methods, interim analyses, or sample-size justification are reported in the registry record.

The registry lists 4 outcome measures and 0 analyses, without a reported multiplicity strategy. This prevents assessment of how multiple outcomes were handled. The record's COMPLETED status and listed adverse-event counts do not resolve these limitations. These are limitations of what can be verified from the registry record; they do not establish what occurred outside the posted record or imply a particular unreported result.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Patient Reported Satisfaction With Contoura LASIK Utilizing the Phorcides Analytic Software — NCT05848817.
• Registry record last updated 2025-07-17; status last verified 2025-07.
• Results first posted 2025-07-17.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

The registry record describes a completed study sponsored by Mann Eye Institute, with enrollment of 50 and myopia listed as the condition. It lists Contoura LASIK, described as Phorcides Planned Contoura LASIK, as the sole intervention. The study began on 2023-05-19 and has a primary completion date of 2024-08-15.

The primary outcome is participant satisfaction with vision at 3 Months Postoperative, defined by answering Completely Satisfied or Very Satisfied to PROWL Questionnaire Question #1. The numerical result and the number assessed are not reported in the registry record. A secondary outcome concerns eyes with postoperative spherical equivalent within +/- 0.50 D, but its result is not reported in the registry record.

No comparator or allocation method is described. The record lists 4 outcome measures and 0 analyses. The adverse-event record lists 0 serious events, 0 other events, and 0 deaths among 50 participants at risk. These registry entries describe the registered study and posted safety counts, but do not supply the primary satisfaction result or establish a comparative treatment effect.