A Prospective, Multicenter Study of the OMNI® Surgical System in Pseudophakic Eyes With Open Angle Glaucoma: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Prospective, Multicenter Study of the OMNI® Surgical System in Pseudophakic Eyes With Open Angle Glaucoma (NCT04465630), a na na study. The primary outcome is Change in Intraocular Pressure (IOP).

2. Clinical Question

3. Trial Design

This was a prospective, multicenter study of the OMNI® Surgical System in pseudophakic eyes with open-angle glaucoma. The registry classifies the trial as single-group, with allocation recorded as NA and masking recorded as NONE. The listed intervention was the OMNI® Surgical System, and the arm description states that eligible participants would receive glaucoma surgery using that device. No separate control arm is described, so the design is not a randomized comparison.

The registry lists enrollment as 78. The study started on 2020-06-19, and its primary completion date is 2021-03-02. Its status is TERMINATED. The record does not state why the study was terminated, so the status alone should not be taken as evidence of a particular safety, efficacy, recruitment, or operational issue. The phase is listed as NA.

The primary outcome was change in intraocular pressure, measured in mmHg, with the outcome parameter described as a mean and dispersion specified as standard deviation. The stated timeframe was six months. The analysis population was described as subjects who reached the six-month postoperative timepoint by study closure. The registry also lists change in number of medications as a secondary outcome.

The study description identifies the intended assessment as the clinical effect of ab-interno transluminal viscoelastic delivery and trabeculotomy on intraocular pressure and use of intraocular-pressure-lowering medications. The registry record does not report a detailed statistical analysis plan, a sample-size justification, or the reason for the chosen follow-up timeframe.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Overall mean change in IOP from baseline for subjects who reached the 6-month time point by study closure

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: Subjects who received the study procedure

6. Primary Endpoint

The registry lists the primary outcome as Change in Intraocular Pressure (IOP), measured over 6 months.

The primary endpoint is change from baseline in unmedicated mean diurnal intraocular pressure at the six-month postoperative timepoint. Intraocular pressure is measured in mmHg. The endpoint is described as a mean, with standard deviation as the measure of dispersion. The specified population comprises participants who had reached the six-month timepoint by study closure, rather than necessarily everyone enrolled.

Mean change is used to describe the average within-participant shift in the measured outcome over time. The standard deviation describes how much individual measurements or changes vary around that average; it is not a measure of uncertainty in the estimated mean. As a general statistical point, the mean gives a compact summary, but it does not show the full spread or shape of participant-level outcomes.

The word “unmedicated” matters to interpretation because the intended pressure measurement is described without pressure-lowering medication. The record does not specify how medication use was managed for measurement, nor does it provide the baseline or follow-up mean, the mean change, the standard deviation, or the number of participants contributing to the endpoint. Those numerical outcome results are not reported in the registry record. As a result, the direction and precision of the observed change cannot be assessed from the record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The design and outcome description determine what can be inferred from this registry record. The study is identified as a prospective, multicenter, single-group study. Its allocation is listed as NA and masking as NONE. Those details mean that the primary endpoint is not presented as a contrast between randomly assigned treatment groups. The outcome is instead defined as change from baseline within the eligible group that reached the specified follow-up timepoint.

What does a mean change represent?

As a general statistical explanation, a mean change summarizes the average difference between participants’ baseline measurements and their later measurements. The mean can be useful for describing the group’s overall trajectory, but it does not show whether most participants changed by a similar amount or whether the mean reflects a smaller number of larger changes. Individual-level distributions or other summaries can help characterize that variation, but those results are not reported in the registry record.

The endpoint specifies unmedicated mean diurnal intraocular pressure, measured in mmHg, and names standard deviation as its dispersion measure. Standard deviation describes variation among observations around the mean. It should not be interpreted as the uncertainty of the estimated mean. A confidence interval, when reported, describes uncertainty about an estimate under its statistical assumptions. No confidence interval for the primary endpoint is reported in the registry record.

Why does the analysis population matter?

The primary outcome description limits the population to participants who reached the six-month postoperative timepoint by study closure. This can differ from the enrolled group. As a general principle, an analysis restricted to participants with a completed follow-up measurement can be affected if the participants with available data differ systematically from those without it. The registry record does not report how many enrolled participants reached the timepoint, how many had usable measurements, or how missing measurements were handled. The impact of incomplete follow-up therefore cannot be assessed.

The endpoint is also described as unmedicated. Medication use may affect the interpretation of pressure measurements, so the specific measurement and medication-handling procedures are important context. The registry record does not report those details in the information available for this analysis. It also does not report how the secondary medication outcome was defined or analyzed.

What can be inferred without a comparator?

In a single-group study, a before-and-after change describes what happened in the observed group over the follow-up period. As a general statistical point, such a change does not identify what would have happened to the same participants over the same period without the intervention. Changes can also reflect measurement variability, other care, natural history, or selection into the analyzed follow-up group. These possibilities are not quantified by the registry information.

A comparative design can estimate a contrast between groups, but this record does not describe a separate control group or randomized allocation. It is therefore not appropriate to interpret the study as a controlled treatment-effect comparison. The posted outcome description can identify the intended estimand—a mean within-group change for participants reaching the stated timepoint—but the numerical estimate itself is not reported.

How should planning illustrations be read?

The sample-size assumptions describe a planning illustration based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The illustration is specified to detect a stated fraction of the observed effect. Such calculations are planning tools, not observations from the trial and not evidence that the trial had a particular probability of detecting an effect. The stated assumptions also describe two-arm allocation, whereas the registered study is single-group; they should not be mistaken for the study’s actual design.

The numeric planning outputs are not reported in the registry record available for this analysis. No sample-size justification for the actual trial is reported in the registry record. In general, a planning calculation depends on its assumed effect, variability, significance threshold, allocation, and desired power. If those inputs differ from the trial’s actual setting, the illustration may not describe the study’s operating characteristics.

What is absent from the inferential record?

The registry lists zero analyses. It does not report the statistical test or model used for the primary endpoint, any adjustment for baseline values or other covariates, a confidence interval, or a p-value. These omissions do not establish that no analyses were conducted; they indicate that such analyses are not reported in the registry record. Without the analysis method and numerical results, readers cannot reproduce or evaluate the inferential claims from this record alone.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Pseudophakic Eyes With Open Angle Glaucoma")
n   <- c(14)
m   <- c(-8.8)
sp  <- c(7.3)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Pseudophakic Eyes With Open Angle Glaucoma  14  -8.800  7.300  -13.015  -4.585

11. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary outcome of change in intraocular pressure and a secondary outcome of change in number of medications. It does not report a multiplicity strategy, such as a hierarchy among outcomes or an adjustment for making more than one statistical comparison. Without a stated plan and reported analyses, the effect of multiple testing on interpretation cannot be assessed. This is a limitation of the information recorded, not evidence that a particular adjustment was or was not used outside the registry record.

Missing-data handling is also not reported in the registry record. The primary endpoint population is defined as participants who reached the six-month postoperative timepoint by study closure, but the record does not give the number with outcome measurements or explain how participants without those measurements were treated analytically. It does not state whether any imputation, sensitivity analysis, or other method was used. In general, conclusions from observed follow-up can be sensitive to why data are missing and whether missingness is related to outcomes or participant characteristics.

The record does not describe the analysis populations beyond the endpoint wording, nor does it state whether all enrolled participants were included in any particular analysis. The number enrolled is 78, but that figure should not be read as the primary endpoint analysis size. The registry lists zero analyses, and no endpoint-specific sample size is reported. Consequently, neither the handling of missing outcome data nor the population underlying an inferential result can be evaluated from the registry record.

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.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: renal failure (unrelated) (1.3%), coronary artery disease (unrelated) (1.3%).

The safety record lists 78 participants at risk for serious adverse events and 2 affected. It lists 78 at risk for other adverse events and 20 affected. The record also lists 0 deaths. These are registry counts for the described study group; they do not provide a comparison with an untreated or alternative-treatment group.

The most frequent serious adverse-event terms listed are Renal Failure (unrelated), at 1.3%, and Coronary Artery Disease (unrelated), at 1.3%. The registry labels both terms as unrelated. That attribution should be read as the record’s classification, not as an independent causal assessment. The figures do not establish that the procedure caused or prevented any event.

Adverse-event counts are not a complete description of risk. Interpretation depends on definitions, observation time, event severity, participant exposure, and how events were collected and classified. The registry record does not report additional details about those aspects in the information available for this analysis. The 78 listed at risk should not automatically be treated as the number with complete follow-up for every safety outcome. The counts also should not be compared directly with results from another study unless populations, follow-up, definitions, and ascertainment methods are sufficiently comparable.

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

The registry record establishes that a prospective, multicenter, single-group study assessed the OMNI® Surgical System in pseudophakic eyes with open-angle glaucoma. Its primary endpoint was defined as change from baseline in unmedicated mean diurnal intraocular pressure at the six-month postoperative timepoint for participants who reached that timepoint by study closure. The record also lists change in number of medications as a secondary outcome.

However, the registry record does not report the numerical primary outcome result, the number of participants contributing to it, or an inferential analysis. It therefore does not show whether mean pressure increased or decreased, how large any change was, how variable participants’ changes were, or how precisely the mean was estimated. The medication outcome’s numerical result is not reported in the registry record either. No conclusion about the magnitude or statistical uncertainty of either outcome can be drawn from the information.

The design also limits what a within-group change could establish even if a numerical result were available. Without a separate comparator, a change from baseline would not by itself distinguish an intervention-associated change from other influences over time. This is a general limitation of single-group before-and-after evidence and does not establish that any particular alternative explanation occurred in this study.

The safety counts describe events recorded for the study group, including 2 participants affected by serious adverse events, 20 affected by other adverse events, and 0 deaths. These counts are not comparative estimates and do not independently determine causality. The serious event terms are labeled unrelated in the registry record.

The study status is TERMINATED, but the reason for termination is not reported in the registry record. The status cannot substitute for outcome data or serve as a conclusion about the intervention. Overall, the record documents the study question, design, and selected safety counts, while leaving the primary effectiveness result and key analysis details unreported.

14. Why This Trial Matters Statistically

This trial is statistically informative as an example of the difference between a clearly stated outcome and a reportable outcome estimate. The registry defines a clinically interpretable measure—change in unmedicated mean diurnal intraocular pressure from baseline at six months—and identifies standard deviation as the dispersion measure. But without the mean change, its uncertainty, and the analysis population size, readers cannot evaluate the observed result’s direction, magnitude, or precision.

The single-group design is also central to interpretation. A within-group change can describe the course of participants who were observed, but it cannot provide the same causal contrast as a randomized comparison. This matters when translating an endpoint definition into a treatment-effect claim: the estimand is a change over time in the observed group, not a difference against a concurrent control.

The endpoint population is defined by reaching the six-month timepoint by study closure. That makes the count and characteristics of participants with available measurements important. The registry record does not report those details or the missing-data approach. Their absence prevents assessment of whether the endpoint estimate represents the enrolled group or a subset with follow-up data.

The safety information adds descriptive counts, but without a comparator or fuller ascertainment detail it cannot support comparative risk estimates. The record’s terminated status and absence of reported outcome analyses further emphasize that enrollment and a defined endpoint do not alone establish an interpretable result. These features make transparency about analysis populations, missingness, uncertainty, and comparative design especially important when reading clinical-trial registries.

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 primary limitation is that the numerical results for the primary endpoint are not reported in the registry record. The mean change, standard deviation, baseline and follow-up values, and uncertainty estimate are absent. The number of participants contributing to the six-month endpoint is also not reported, so the analysis population cannot be identified from the enrollment figure alone.

The study is single-group and has no separate comparator. As a result, a within-group change would not isolate the effect of the intervention from other influences over time. The registry record does not provide a randomized comparison or report adjusted analyses that might offer a different form of comparison.

The record does not report why the study was terminated, how missing outcome measurements were handled, or whether the six-month endpoint population differed from the enrolled group. It also does not provide a detailed statistical analysis plan, sample-size justification, multiplicity approach, or inferential analysis. The registry lists zero analyses, so readers cannot assess the model or test used for the stated endpoint.

Safety information is limited to the listed counts, event terms, and attribution labels. Further detail about follow-up, event collection, and classification is not reported in the registry record. The counts therefore should be read descriptively rather than as comparative evidence of risk. These limitations concern what the registry record reports; they do not establish what may have been analyzed or documented elsewhere.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Prospective, Multicenter Study of the OMNI® Surgical System in Pseudophakic Eyes With Open Angle Glaucoma — NCT04465630.
• Registry record last updated 2022-06-28; status last verified 2022-05.
• Results first posted 2022-06-07.
• 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

NCT04465630 is a prospective, multicenter, single-group study of the OMNI® Surgical System in pseudophakic eyes with open-angle glaucoma. The registry lists enrollment of 78, study start on 2020-06-19, primary completion on 2021-03-02, and status TERMINATED. Allocation is listed as NA and masking as NONE.

The primary outcome is change in unmedicated mean diurnal intraocular pressure from baseline at the six-month postoperative timepoint among participants reaching that timepoint by study closure. Change in number of medications is listed as a secondary outcome. Numerical outcome results and endpoint-analysis size are not reported in the registry record. Safety counts include 2 participants affected by serious adverse events, 20 affected by other adverse events, and 0 deaths; the listed serious event terms are labeled unrelated.