This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Clinical Study for TONOREF III Tested to ANSI Z80.10-2014 (NCT07152808), a na phase not stated study. The primary outcome is Agreement of Intraocular Pressure.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT07152808 |
| Phase | Phase not stated |
| Condition | Intraocular Pressure |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 52 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Nidek Co. LTD. |
| Results posted | Yes |
2. Clinical Question
The study asks whether intraocular pressure measurements from TONOREF III are comparable to measurements from the Goldmann applanation tonometer, identified as the predicate device. The registry describes the primary objective as assessing agreement between the devices. It also states a secondary safety objective and lists the number of adverse events as a secondary outcome.
Population
The registry record lists 52 enrolled participants with intraocular pressure as the condition. It does not provide further eligibility details or a fuller description of the population in the primary outcome entry.
Intervention
Participants underwent intraocular pressure measurement using TONOREF III, the investigational device. The registry identifies it as the representative device of the NIDEK tonometer series.
Comparator
The comparator was the Haag-Streit Goldmann manual tonometer, also described as the Goldmann applanation tonometer. The registry calls it the predicate device.
Primary question
How similar were the intraocular pressure measurements from the two devices? The registry record does not report the measured agreement or a numerical comparison, so the size and precision of any observed difference cannot be assessed from the posted results.
3. Trial Design
This was a completed, single-group clinical pilot study sponsored by Nidek Co. LTD. The registry lists enrollment of 52 and dates the study from 2022-09-02, with primary completion on 2023-06-19. Its title identifies testing against ANSI Z80.10-2014, and the official title describes a pilot study intended to provide research data.
Participants were to undergo intraocular pressure measurements using both TONOREF III and the predicate Goldmann applanation tonometer. The registry classifies the design as single-group, gives allocation as not applicable, and records masking as none. Thus, the record describes measurements from both devices in the same study group, rather than separate randomized treatment groups. It does not describe a randomized comparison.
The primary outcome concerns agreement in measured intraocular pressure, expressed in mmHg, and is defined using the mean and standard deviation. The stated timeframe is 1-2 study visits per subject over the course of 8 days. The registry lists the number of adverse events as a secondary outcome. Although the study status is completed, the registry record does not report the primary endpoint results or an analysis of the outcome measures.
Details such as the order of device measurements, measurement procedures beyond the device names, eligibility criteria, and the statistical analysis plan are not reported in the registry record. They should not be inferred from the single-group designation or from the objective of assessing agreement.
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
| Stage | TONOREF III and Goldmann Tonometer Measurements |
|---|---|
| STARTED | 52 |
| COMPLETED | 42 |
| NOT COMPLETED | 10 |
Reasons for not completing this period:
| Reason | TONOREF III and Goldmann Tonometer Measurements |
|---|---|
| screening failure | 10 |
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.
| Characteristic | Unit | TONOREF III and Goldmann Tonometer Measurements |
|---|---|---|
| Participants analysed | 42 | |
| Age, Continuous | years | 64.6 (SD 12.74) |
| Sex: Female, Male: Female | Participants | 24 |
| Sex: Female, Male: Male | Participants | 18 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 5 |
| Race (NIH/OMB): White | Participants | 37 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 42 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Agreement of Intraocular Pressure, measured over 1-2 study visits per subject over the course of 8 days.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | mmHg |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is agreement between intraocular pressure measurements made with TONOREF III and the Goldmann applanation tonometer. The measurement unit is mmHg, and the registry describes the outcome in terms of a mean and standard deviation. The outcome timeframe is 1-2 study visits per subject over the course of 8 days.
Agreement is relevant when two devices are intended to measure the same quantity: the question is how closely their readings correspond, not whether one group has a better clinical outcome than another. A mean can describe the average measurement level, while a standard deviation describes the spread of measurements around that mean. For device comparison, these summaries can help characterize readings, but by themselves they do not fully describe how closely paired readings agree across individuals. General statistical interpretation of agreement may also consider the distribution of within-person differences and the range of differences judged acceptable for the intended use. Such criteria and analyses are not reported in the registry record.
The record states the endpoint’s purpose but does not provide the actual device measurements, an agreement estimate, or its uncertainty. Consequently, the endpoint’s observed magnitude and precision cannot be evaluated from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies agreement of intraocular pressure measurements as the primary objective, but it does not report a numerical primary outcome result. There is no posted mean, standard deviation, estimate of agreement, confidence interval, or test result for the device comparison. The direction and magnitude of any difference between readings therefore cannot be described, and the precision of the comparison cannot be assessed.
The study design indicates that participants underwent measurement with both devices. This is a within-participant setup: each participant can contribute measurements from each device, so a comparison can account for the fact that readings from one person may be related to one another. General statistical interpretation of such data depends on the actual paired measurements and the analysis method. The registry does not report those measurements or the method used to analyze them.
The stated primary objective uses the term comparable, but the registry record does not report a prespecified acceptable difference or a decision rule for determining comparability. A finding of similarity cannot be established solely from a study objective or from the fact that both devices were used. It requires reported results and an interpretable criterion. No conclusion about whether the devices met such a criterion can be drawn from the posted information.
The study enrolled 52 participants, but enrollment alone does not indicate how precisely agreement was estimated. Precision depends on the observed data and the analysis, not simply on the number enrolled. The record does not report the number included in the primary analysis, exclusions, missing measurements, or an estimate with uncertainty.
The safety record lists 52 participants at risk for serious and other adverse events, with 0 affected in each category and 0 deaths. These figures describe the recorded counts for this study group. They do not supply a comparative safety estimate, because the record does not describe distinct randomized groups. The limits of interpreting these counts are discussed in the safety reading and limitations.
Overall, the registry describes the study question, design, and recorded safety counts, but not the primary measurement results. The evidence needed to characterize observed agreement and its uncertainty is not reported in the registry record.
9. Statistical Methods Explained
The outcome is a continuous measurement: intraocular pressure in mmHg. The registry identifies the primary summary as a mean with standard deviation. These are descriptive statistics. The mean gives the average level of a set of measurements; the standard deviation describes their spread around that average. They summarize different features of the data and should not be treated as interchangeable.
What does agreement mean?
In general, agreement asks how closely two measurement methods give the same readings for the same underlying quantity. Correlation, by contrast, concerns whether measurements vary together. Two methods can move together across individuals without giving sufficiently close readings for individual measurements. For that reason, an agreement analysis is not established simply by reporting a correlation, and a correlation result would not substitute for an agreement estimate. The registry record does not identify the specific agreement statistic used in this study.
A common general approach to paired measurement data is to calculate the difference between the two readings for each participant and examine both the average difference and the spread of those differences. The average difference can indicate systematic offset, while the spread shows how much individual pairs vary. A confidence interval can communicate uncertainty around an estimate: generally, it gives a range of values compatible with the data and the assumptions of the method. Neither such differences nor their uncertainty are reported for this study.
Why does the paired structure matter?
Because the registry says each subject undergoes measurement with both devices, measurements from the same subject are not necessarily independent. General analyses of paired data use the within-subject relationship rather than treating all device readings as if they came from unrelated people. The measurement order, number of readings per device, handling of repeated measurements, and exact statistical model are not reported in the registry record. It is therefore not possible to determine how within-subject dependence was handled in the analysis.
The registry names the mean and standard deviation but does not explain whether these summaries were calculated separately for each device, for paired differences, or in another way. Nor does it report a confidence interval, a formal hypothesis test, or an acceptable agreement margin. These distinctions matter: a descriptive summary, a test of a difference, and an assessment against a prespecified agreement threshold answer different questions.
What can be concluded from the posted analysis information?
The record lists 2 outcome measures and 0 analyses. It provides no numerical primary endpoint result or analysis description. The stated objective and endpoint definition are not a substitute for an analysis result. The statistical model, any adjustment, the treatment of repeated readings, and the handling of outliers are not reported in the registry record.
The study-size assumptions describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The illustration is not the trial’s own design justification. The record does not provide the observed effect or the resulting planning counts in the registry record for interpretation. Such a planning illustration is not observed power and should not be read as evidence that the study had a particular probability of detecting an effect.
In general, over-dispersion means that observed variability exceeds what a statistical model assumes. When present, it can make standard errors too small if the extra variability is ignored, leading to intervals that are too narrow and tests that are too optimistic. Whether over-dispersion is relevant depends on the outcome and model. The registry does not report a model or an assessment of over-dispersion for this continuous measurement outcome, so no such issue can be attributed to this study.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists the primary agreement outcome and a secondary outcome concerning the number of adverse events. It records 2 outcome measures and 0 analyses, but does not provide the results or analysis details for either outcome. A statistical analysis plan, including any planned hierarchy or adjustment for multiple testing, is not reported in the registry record.
In general, multiplicity arises when several outcomes, comparisons, time points, or analytic choices are examined. If many tests are conducted, the chance of at least one apparently notable result can increase. A prespecified hierarchy or adjustment can address some multiplicity concerns, but it is not possible to say whether such measures were planned or used in this study.
Missing-data handling is also not reported in the registry record. The entry does not state whether all enrolled participants completed measurements, how incomplete device pairs were handled, or whether any imputation or other missing-data method was used. The enrollment count does not establish the number contributing to each endpoint analysis.
The analysis population is not reported in the registry record. There is no stated rule describing which participants or readings were included in the primary analysis. Consequently, readers cannot determine whether the analysis used all enrolled participants, only those with paired measurements, or another defined group. These omissions limit evaluation of potential bias and reproducibility; they do not establish that missing data or multiplicity problems occurred.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| TONOREF III and Goldmann Tonometer Measurements | 0 | 52 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| TONOREF III and Goldmann Tonometer Measurements | 0 of 52 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| TONOREF III and Goldmann Tonometer Measurements | 0 of 52 |
The registry lists 52 participants at risk for serious adverse events and 0 affected. It also lists 52 at risk for other adverse events and 0 affected, with 0 deaths. No serious adverse event terms are listed. These are the safety counts recorded for the TONOREF III and Goldmann Tonometer Measurements group.
These figures should be read as counts within the study group, not as a comparison between randomized treatment arms. The registry describes a single-group study in which participants underwent measurements with both devices; it does not describe separate randomized groups for a between-group safety comparison. The counts therefore do not estimate a relative safety difference between devices.
Zero recorded affected participants does not establish that an event is impossible or that the devices have identical safety profiles. Safety interpretation depends on the number observed, the duration and completeness of follow-up, event definitions, and ascertainment procedures. The registry states a timeframe for the primary endpoint, but the safety follow-up details and event-collection procedures are not reported in the registry record. The listed counts are thus a description of the posted safety record, not a broader estimate of risk.
12. What the Result Does, and Does Not, Mean
The study is designed to examine whether readings from TONOREF III agree with readings from the Goldmann applanation tonometer. That is a measurement-comparison question, not a comparison of clinical outcomes or a test of treatment effectiveness. The registry identifies the device pair, the intraocular pressure outcome, and the general study structure.
The posted record does not report the primary measurement results. Without the observed readings or a numerical estimate of agreement, it is not possible to describe how closely the devices agreed, whether one tended to read higher or lower, or how variable the paired readings were. The record also does not provide an acceptable agreement threshold or a decision rule for interpreting comparability. No claim that the devices are equivalent, interchangeable, or clinically different follows from the objective alone.
The enrollment of 52 participants gives context for the study but does not by itself establish the precision or generalizability of any potential estimate. The number contributing to the primary analysis and the characteristics of the enrolled participants beyond the registry’s limited description are not reported in the registry record.
The safety counts show 0 affected among 52 at risk in each listed adverse-event category and 0 deaths. They are descriptive counts for this study group. They do not demonstrate the absence of all possible adverse events, nor do they provide a comparative safety estimate.
The registry record therefore supports a limited conclusion about what the study set out to examine and how it was broadly structured. It does not provide enough outcome information to judge the observed measurement agreement or its precision. Those conclusions would require reported analyses and results that are not reported in the registry record.
13. Why This Trial Matters Statistically
Device agreement is a statistical question distinct from whether measurements are associated or whether average readings are similar. A device comparison may be intended to establish whether readings are close enough for a particular use, but that interpretation requires an agreement estimate and a criterion for acceptable differences. The registry’s focus on agreement makes these distinctions central to interpreting the study objective.
The study’s single-group structure, with each participant measured using both devices, is also important statistically. Paired observations can provide a direct within-person comparison, while analyses that ignore pairing may fail to represent how measurements from the same person relate. The registry states that both measurements were taken but does not report the analysis used to account for their relationship.
The registry record has value as a description of a completed clinical pilot study: it identifies the devices, the measurement outcome, the stated timeframe, enrollment, and safety counts. At the same time, its lack of reported primary results means that readers cannot assess the magnitude or precision of agreement. This distinction matters in evidence appraisal: a clearly stated question is not itself evidence of the answer.
More broadly, transparent reporting of outcome estimates, uncertainty, analysis populations, and missing-data methods allows readers to evaluate whether a measurement comparison is informative. Those details are not reported in the registry record. The study’s statistical importance therefore lies in the measurement question and design described, while the posted information leaves the main empirical question unresolved.
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.
The principal limitation for interpreting this study is that the registry record does not report the primary endpoint results. No numerical agreement estimate, device-specific summary, confidence interval, or analysis result is available in the record. Without these, neither the size nor precision of agreement can be assessed.
The record also does not state a prespecified threshold for acceptable agreement or explain how comparability was to be judged. It does not report the statistical method used, how paired readings were handled, or whether repeated measurements were combined or analyzed separately. The order of measurements and procedural details are not reported in the registry record.
Further information about participant eligibility and characteristics, the number included in the endpoint analysis, missing measurements, and the analysis population is not reported in the registry record. These omissions prevent assessment of how representative the analyzed participants were and how incomplete data may have influenced any estimate. They do not establish that measurements were missing or that the analysis was biased.
The study is identified as a clinical pilot with 52 enrolled participants. The registry does not report a sample-size justification for the study’s own design, and the planning illustration described in the record is not a substitute for one. The safety counts are also limited to the recorded group and cannot establish comparative safety between devices. Together, these reporting gaps constrain interpretation without determining what the unreported results would show.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Clinical Study for TONOREF III Tested to ANSI Z80.10-2014 — NCT07152808.
- Registry record last updated 2026-04-24; status last verified 2026-04.
- Results first posted 2026-02-04.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT07152808 is a completed clinical pilot study sponsored by Nidek Co. LTD. Its stated objective was to assess agreement between TONOREF III and the predicate Goldmann applanation tonometer for intraocular pressure measurements, with a secondary safety objective.
The registry lists a single group, no masking, enrollment of 52, and a primary outcome of agreement in mmHg based on a mean and standard deviation. The stated timeframe was 1-2 study visits per subject over the course of 8 days. Safety counts list 0 affected participants for serious and other adverse events and 0 deaths.
The registry record does not report the primary endpoint results, analysis methods, analysis population, or missing-data handling. Accordingly, the magnitude and precision of device agreement cannot be assessed from the posted record.