Preoperative iLux on Cataract Surgery Derived Dry Eye Disease Due to Meibomian Gland Dysfunction: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Preoperative iLux on Cataract Surgery Derived Dry Eye Disease Due to Meibomian Gland Dysfunction (NCT06483750), a randomized na study. The primary outcome is Change in Lipid Layer Thickness (LLT) From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up.

2. Clinical Question

The clinical question is specifically about the difference in change between the groups, not simply whether LLT changed over time within either group. The endpoint is defined as the value four weeks after surgery minus the value at baseline, two weeks before surgery. Under that definition, a positive change indicates an increase from baseline and a negative change indicates a decrease. The results describe the observed groups and the precision of their comparison; they do not by themselves establish what would happen in other populations or settings.

3. Trial Design

The registry describes a randomized, parallel-group study with no masking. The two groups were a control group receiving no Systane iLux treatment and an intervention group receiving Systane iLux treatment. Both descriptions place the treatment decision at the baseline visit two weeks before cataract surgery. The study is listed as completed, with an enrollment of 30. The registry identifies George Washington University as the sponsor and gives the study start as 2024-06-03 and primary completion as 2025-02-01.

The primary endpoint was change in lipid layer thickness from baseline to four weeks after cataract surgery. Three secondary outcomes were also posted: change in the Standard Patient Evaluation of Eye Dryness questionnaire score, change in the Ocular Surface Disease Index questionnaire score, and change in meibomian gland score. These outcomes use the same stated baseline and follow-up timing. The primary endpoint and each secondary outcome are presented as continuous measures with group means and standard deviations.

For objective ophthalmic measures, the record says measurements were taken in the eye undergoing cataract surgery, with one eye per participant, and that analyses were conducted at the participant level. This clarifies the unit represented by the eye measurements, but the registry record does not describe the randomization procedure, allocation concealment, masking of outcome assessors, or detailed eligibility criteria. It also does not report a protocol-specific statistical analysis plan, the original sample-size justification, or whether any interim analyses were planned. Those details should not be inferred from the randomized label or the posted summary statistics.

The registry enrollment and the endpoint summaries serve different descriptive purposes. The record lists enrollment as 30, while the primary outcome summaries report 14 participants in the control group and 15 in the iLux group. The registry record does not explain the relationship between enrollment and the numbers contributing to the endpoint summaries. In particular, it does not describe exclusions, withdrawals, or missing outcome measurements.

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: Analyses were conducted at the participant level. For objective ophthalmic measures, assessments were performed in the eye undergoing cataract surgery (one eye per participant).

Overall Study

Analysis population for the primary outcome, as defined in the registry: Analyses were conducted at the participant level. For objective ophthalmic measures, assessments were performed in the eye undergoing cataract surgery (one eye per participant)

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 Change in Lipid Layer Thickness (LLT) From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up, measured over Baseline (2 weeks prior to cataract surgery) and 4 weeks after cataract surgery.

The primary endpoint is change in lipid layer thickness, abbreviated LLT, between baseline two weeks before cataract surgery and follow-up four weeks after surgery. LLT was measured using LipiView II and reported in nanometers. For each participant, the change is defined as the follow-up value minus the baseline value. A positive change therefore represents an increase from baseline, while a negative change represents a decrease. The record states that higher LLT values indicate a thicker lipid layer and improved tear film stability.

This endpoint provides an objective ophthalmic measurement for comparing the groups’ change over the perioperative period. It is distinct from a symptom questionnaire: it records a measured tear-film characteristic rather than a participant-reported score. The focus on change also makes the comparison about how the measure moved from the preoperative baseline to follow-up, rather than only comparing a single value at follow-up.

The posted group means are mean changes, and the accompanying standard deviations describe variation in those changes among participants. The treatment-versus-control estimate is a difference between the group mean changes. The registry record does not describe a separately adjusted endpoint model or report baseline LLT values by group. Consequently, interpretation should stay with the posted change summaries and their unadjusted comparison rather than assume additional adjustment or details about the measurement process.

7. Results Posted in the Registry

• Systane iLux Treatment: mean 19.50 versus -1.90 on control; difference 21.40 (95% CI 18.12 to 24.68), standardized effect d = 4.76; 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.

Change in Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up

• 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:
  • Systane iLux Treatment: mean -3.40 versus 0.60 on control; difference -4.00 (95% CI -5.36 to -2.64), standardized effect d = -2.16; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Systane iLux Treatment than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Change in Ocular Surface Disease Index (OSDI) Questionnaire Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up

• 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:
  • Systane iLux Treatment: mean -11.80 versus -0.10 on control; difference -11.70 (95% CI -14.50 to -8.90), standardized effect d = -3.04; z-test p = <0.001.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Systane iLux Treatment than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Change in Meibomian Gland Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up

• 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:
  • Systane iLux Treatment: mean -0.27 versus 0.21 on control; difference -0.48 (95% CI -0.80 to -0.16), standardized effect d = -1.08; z-test p = 0.004.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for Systane iLux Treatment than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

The secondary results show a consistent pattern of separation between the groups in the posted mean changes, but the meaning of the direction depends on the scale. The record identifies the SPEED and OSDI measures as questionnaire scores and includes a meibomian gland score; it does not state the scoring interpretation or a clinically important threshold for these secondary endpoints. Accordingly, the direction of a numerical change alone should not be treated as proof of improvement or worsening.

The secondary outcomes complement the primary LLT result by covering participant-reported dryness measures and a gland-related measure alongside an objective lipid-layer measurement. They address related aspects of the study question, but they are not interchangeable: each outcome has its own scale and measurement process. Their joint pattern may be relevant when considering whether the primary finding is accompanied by changes in other measured domains, while still requiring scale-specific interpretation.

The registry posts unadjusted comparisons for the secondary outcomes and does not report a multiplicity adjustment or a prespecified hierarchy among them. When several outcomes are examined, some may appear statistically notable by chance, even if the broader evidence is limited. This makes secondary findings less definitive than a clearly prespecified primary comparison and warrants attention to their confidence intervals, p-values, measurement properties, and consistency with the primary endpoint.

No investigator-reported analyses are listed for these outcomes in the registry record. The posted summary statistics therefore do not establish that all secondary endpoints were analyzed according to a common model, nor do they show how missing measurements or multiple testing were handled. The secondary outcomes add context, but should not be used alone to make a broad claim about treatment effects.

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

• Change in Standard Patient Evaluation of Eye Dryness (SPEED) Questionnaire Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up
• Change in Ocular Surface Disease Index (OSDI) Questionnaire Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up
• Change in Meibomian Gland Score From 2 Weeks Pre-operative Baseline to 4 Weeks Post-operative Follow-up

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous: it is a measurement in nanometers, and the registry reports a mean and standard deviation for each group. For a continuous outcome, a mean describes the group’s average observed change. The standard deviation describes how dispersed individual changes are around that average. These are different quantities: the mean summarizes the group’s central value, while the standard deviation describes participant-level variation.

The change score is defined as the follow-up value minus the baseline value. This direction matters for interpreting signs. A positive group mean indicates an average increase from baseline; a negative group mean indicates an average decrease. The between-group estimate is the iLux group mean change minus the control group mean change. On this scale, a positive estimate means the iLux group had the higher average change. That interpretation follows the stated arithmetic definition and does not, by itself, establish the clinical importance of the contrast.

A confidence interval describes uncertainty around an estimated quantity. For a difference in means, it gives a range of values that are compatible with the data and the calculation’s assumptions. The interval’s width conveys precision: narrower intervals indicate less uncertainty about the estimated difference, while wider intervals indicate more. The registry record does not state the confidence level or the investigator’s method for producing the interval. The interval and p-value are therefore best treated as posted unadjusted comparison statistics, not as a full account of a prespecified analysis.

The p-value is also conditional on a statistical model. It describes how surprising a result at least as extreme as the observed one would be if the null hypothesis of no group difference held and the model assumptions were appropriate. It is not the probability that the null hypothesis is true, and it does not measure the size or clinical importance of the effect. The primary comparison’s p-value is unadjusted. The registry record does not report whether the investigators used a different inferential analysis or applied any adjustment for multiple outcomes.

Random allocation and a parallel-group structure describe the design, not every detail of analysis. In a randomized trial, the comparison is intended to use assignment to treatment as the basis for evaluating group differences. A parallel-group design means the groups are followed under their assigned conditions rather than participants crossing between conditions in the posted design description. The registry says masking was none, but does not specify whether outcome assessors were masked or whether other procedures could have reduced knowledge of assignment.

Analysis populations and missing observations matter because the estimate depends on which participants’ measurements are included and how absent measurements are handled. The registry states that analyses were conducted at participant level and that the objective eye measures used the eye undergoing surgery, one eye per participant. It does not state whether the outcome summaries follow an intention-to-treat population, a per-protocol population, or another rule. It also does not describe imputation, complete-case analysis, reasons for missing data, or sensitivity analyses. The difference between the enrollment entry and the endpoint summary counts is therefore not explained by the record.

The study has one posted primary outcome and three posted secondary outcomes. Testing multiple endpoints can increase the chance of observing at least one apparently unusual result even when none reflects a true effect. A multiplicity strategy can address that issue, but the registry record does not report whether one was planned or used. The secondary p-values are unadjusted, and their interpretation should take account of that status, the number of outcomes, and the lack of a reported analysis plan.

Over-dispersion is a concern in analyses of count data when variability exceeds what a simple count model expects. It is not a central issue for the posted endpoint summaries, which are continuous means and standard deviations rather than count outcomes. More generally, statistical methods should match the outcome scale and design; the registry record does not identify the model used by the investigators. No particular distributional assumption, covariate adjustment, or repeated-measures method should be attributed to the trial without a report of it.

The planning figures are illustrations based on the observed effect and a stated normal approximation, rather than a record of the original design calculation. Such illustrations answer a conditional question: what group size would be estimated under specified assumptions for a chosen fraction of the observed effect? They do not reveal the trial’s original rationale or demonstrate that the completed study had a particular probability of detecting an effect. The registry record does not report the trial’s own sample-size assumptions or justification.

11. Confidence Intervals and Precision

The primary between-group estimate is 21.4 nanometers, with a confidence interval from 18.12 to 24.68. This interval communicates uncertainty around the estimated mean difference, not the range of individual participant changes. The interval does not include zero, which is consistent with the posted unadjusted p-value < 0.001. The registry record does not report the confidence level or the method used to calculate the interval, so those aspects cannot be independently characterized from the record.

Precision is shaped by the observed variability and the number of measurements contributing to the comparison. The primary group standard deviations are 4.6 nanometers in the control group and 4.4 nanometers in the iLux group. Endpoint summaries report 14 participants for control and 15 for iLux. These figures help describe the data behind the estimate, but they do not remove uncertainty about selection, missing observations, measurement procedures, or analysis choices.

The interval is comparatively concentrated around a positive difference, but statistical precision is not the same as clinical relevance. The registry explains that higher LLT indicates a thicker lipid layer and improved tear film stability, yet it does not report a threshold for a clinically important change. The interval therefore supports interpretation of the scale and uncertainty of the group contrast, but it does not determine whether the contrast is meaningful to patients or durable beyond the stated follow-up.

Other limitations on precision assessment include the absence of a reported analysis plan, confidence level, missing-data approach, and adjusted analysis. The result should be read as a precise-looking posted estimate under unspecified calculation details, not as a complete account of every uncertainty that could affect the inference.

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 figures are planning illustrations based on fractions of the observed effect. They give participants per arm, not a total across the study. The stated 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 the stated fraction of the observed effect. These are assumptions for the illustration, not reported assumptions from the trial’s original design.

The 80% power column describes the estimated participants per arm for a design that, under those planning assumptions, would have an 80% chance of detecting the specified effect if that effect were the true one. The 90% power column expresses the corresponding planning target for a 90% chance. Higher planned power generally requires more participants for a given effect, and smaller effects require more participants than larger effects under the same assumptions. The curve should be read as a visual representation of this relationship, rather than as a forecast of the results of a future study.

The rows use 100%, 75%, and 50% of the observed effect. Reducing the assumed effect while holding the other assumptions constant increases the planned group size in the posted illustrations. The resulting figures can be very small for some outcomes because they are mechanically based on the observed estimates and the stated approximation. They should not be mistaken for a practical recruitment recommendation or for a sample-size rationale that the investigators used.

This is not observed power. It is a planning calculation based on the observed effect, and it does not show the probability that the completed trial detected an effect. The registry record does not report the original sample-size justification or planning assumptions.

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 = 21.400; pooled standard deviation σ = 4.497.
2. n = 2 × (1.96 + 0.842)² × 4.497² / 21.400² = 0.7, rounded up to 1 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 <- 21.4                      # observed difference in means
sigma <- 4.49740666013945                     # 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(6483750)
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 (80% power), 1 (90% power)
 75% of observed effect: n per arm = 2 (80% power), 2 (90% power)
 50% of observed effect: n per arm = 3 (80% power), 4 (90% power)
power.t.test: 2.2 
Simulated power at n = 1 per arm: NA (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. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary outcome and three secondary outcomes. It does not report whether the investigators specified a hierarchy among these endpoints, limited formal testing to the primary outcome, or adjusted for multiple comparisons. The posted p-values are unadjusted. Without a reported multiplicity plan, the secondary p-values should be interpreted cautiously because evaluating several outcomes can increase the chance of nominally notable findings.

The record lists no reported analyses. This does not establish that analyses were not performed; it means that investigator-reported analysis details are not available in the registry record. The method used for the primary estimate, any covariate adjustment, the planned handling of repeated measurements, and any sensitivity analyses are not reported in the registry record. The same applies to a prespecified definition of the analysis population.

The endpoint summaries give group-specific participant counts, but the registry does not explain missingness or the relationship between the enrollment entry and the endpoint counts. Reasons for missing outcomes, withdrawals, exclusions, and the treatment of participants without follow-up data are not reported in the registry record. No imputation strategy or missing-data sensitivity analysis is described. These gaps limit assessment of whether the posted comparisons could be affected by selective availability of measurements.

The record does specify that analyses were conducted at participant level and that objective measures came from the eye undergoing surgery, one eye per participant. It does not say whether the groups were analyzed as randomized or under another population definition. No intention-to-treat label, per-protocol rule, or other analysis-population description is reported. These omissions do not invalidate the posted summaries, but they restrict independent assessment of how the trial’s design and data were translated into the reported results.

15. 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 registry reports zero serious adverse events in the control group, with 14 participants at risk, and zero in the Systane iLux group, with 15 participants at risk. It also reports zero other adverse events in each group, with the same respective numbers at risk, and zero deaths in both groups. No serious adverse event terms are listed.

These figures describe events recorded in the registry for the stated groups and risk sets. They do not show that no events of any kind occurred outside the registry’s definitions or reporting period, and they do not establish that an intervention is free of risk. The record does not give detailed adverse-event definitions, collection methods, event observation duration beyond the study context, or a narrative of events. With relatively small endpoint groups, zero recorded events also provides limited information about uncommon harms. Safety interpretation should therefore remain confined to the posted counts and the reporting detail available in the registry record.

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

The primary result indicates that the mean LLT change was higher in the Systane iLux group than in the no-treatment control group over the stated baseline-to-follow-up period. The estimated mean difference was 21.4 nanometers, and the confidence interval from 18.12 to 24.68 lies above zero. The unadjusted p-value was < 0.001. These statistics describe the posted comparison; they do not establish that the treatment caused the difference or that it would be seen in a different population.

The endpoint is an objective measure, and the registry states that higher LLT values indicate a thicker lipid layer and improved tear film stability. However, the result does not by itself establish a change in symptoms, quality of life, or other clinical outcomes. The secondary outcomes provide additional measures, but their score interpretation and clinical importance are not fully specified in the registry record. The findings also apply to the recorded follow-up timing; longer-term outcomes are not reported.

A statistically distinct estimate is not automatically a clinically important one. The record does not give a threshold for a meaningful LLT change, and the interval does not answer questions about the durability of the observed difference. Likewise, the absence of reported adverse events should not be interpreted as evidence that adverse effects cannot occur.

The randomized design is relevant to the comparison, but the record does not provide important details about allocation procedures, missing data, or the investigators’ analysis plan. No masking is reported. The registry’s enrollment entry and endpoint summary counts are not reconciled by an explanation. These limitations mean that the posted results are best understood as a description of the reported data and comparison, rather than a complete causal or clinical assessment.

17. Why This Trial Matters Statistically

This trial is statistically informative because it places an objective ophthalmic measure alongside questionnaire and gland-score outcomes in a randomized, parallel-group comparison around cataract surgery. The primary endpoint is explicitly defined as change from a preoperative baseline to postoperative follow-up, making the direction of the mean changes and between-group estimate interpretable. The registry also identifies the eye-measurement unit and states that analyses were conducted at participant level.

The posted primary estimate is separated from zero by its confidence interval, and the unadjusted p-value is small. At the same time, the endpoint groups are small, the registry does not explain the counts contributing to the summaries, and key analysis details are absent. These features make the trial a useful example of why a striking numerical estimate should be considered alongside its uncertainty, the completeness of reporting, and the scope of the study.

The secondary results illustrate another statistical issue: related outcomes can add context but also create multiplicity concerns. Without a reported testing strategy, several unadjusted findings should not be treated as equivalent confirmations of a primary result. In addition, measurement scales need to be interpreted according to their definitions; a negative change is not inherently beneficial or harmful without knowing the scale direction.

The registry record therefore supports discussion of effect estimates, confidence intervals, unadjusted testing, analysis populations, missing-data reporting, and planning calculations. It does not provide all the information needed to reconstruct the original statistical plan or make broader conclusions about clinical benefit.

18. 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 reporting gaps constrain interpretation. The registry lists an enrollment of 30, while the primary endpoint summaries list 14 participants in the control group and 15 in the Systane iLux group. The record does not explain why the endpoint counts differ from the enrollment entry, whether participants lacked follow-up measurements, or whether exclusions occurred. Reasons for missingness and the method used to handle it are not reported in the registry record.

The study is listed as unmasked, and details of allocation concealment and outcome-assessor masking are not reported. This is relevant because the study includes both objective measurements and participant questionnaires, which can be affected differently by knowledge of assignment. The record does not describe the measurement protocol beyond identifying LipiView II for LLT, nor does it give details of assessor training or measurement reliability.

Follow-up for the posted outcomes is four weeks after cataract surgery. The registry does not provide longer-term measurements, so persistence of the reported changes cannot be evaluated from these results. It also does not report baseline group values for the primary endpoint, only the change summaries, or a threshold for clinical importance. The interpretation of questionnaire and gland-score directions is not specified in the outcome descriptions.

Finally, the registry record does not report the original sample-size justification, a detailed statistical analysis plan, adjusted analyses, or a multiplicity approach. The comparison statistics are unadjusted, and the secondary findings should be considered in that context. These limitations do not alter the posted arithmetic, but they narrow what can be concluded from it.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Preoperative iLux on Cataract Surgery Derived Dry Eye Disease Due to Meibomian Gland Dysfunction — NCT06483750.
• Registry record last updated 2026-05-15; status last verified 2026-05.
• Results first posted 2026-05-15.
• 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.

22. Record Summary

NCT06483750 is a completed randomized, parallel-group study sponsored by George Washington University. The registry lists no masking and an enrollment of 30. The study compares Systane iLux treatment at a baseline visit two weeks before cataract surgery with no Systane iLux treatment at that visit.

The primary outcome is change in LLT from baseline to four weeks after surgery, measured in nanometers. The posted comparison favors a higher mean change in the iLux group, with an estimate of 21.4, a confidence interval from 18.12 to 24.68, and an unadjusted p-value < 0.001. Three secondary outcomes are also posted. The registry record does not report investigator analyses, the original sample-size rationale, multiplicity handling, or the approach to missing data.