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 Twenty-four Hour Intraocular Pressure Patterns in Patients With Uncontrolled Thyroid Eye Disease (NCT01798966), a na na study. The primary outcome is Change in IOP Before and After Orbital Decompression Surgery.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01798966 |
| Phase | NA |
| Condition | Thyroid Eye Disease |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 10 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Sensimed AG |
| Results posted | Yes |
2. Clinical Question
Population
Patients with thyroid eye disease and orbital congestion who require orbital decompression surgery. The registry record lists an enrollment of 10.
Intervention
Orbital decompression surgery, with SENSIMED Triggerfish monitoring before and after surgery. The device is described as being worn for 24h.
Comparator
The comparison is each patient’s pre-surgery and post-surgery monitoring. There is no separate control group in the single-group design.
Primary question
Does SENSIMED Triggerfish output during the transition from wake to sleep differ before and after orbital decompression surgery?
The clinical rationale in the registry record is that thyroid eye disease can enlarge orbital contents, leaving less space within the orbit and potentially compressing or displacing the globe. Decompression surgery is described as creating more room for those contents. The study is intended to characterize whether the measured intraocular pressure pattern changes after that mechanical compression is relieved.
The question concerns patterns across a 24-hour monitoring period, not simply a single pressure reading. The primary outcome description focuses specifically on the wake-to-sleep transition. A secondary outcome is identified as IOP patterns, but the registry record does not report detailed definitions for the secondary outcome measures.
This is a before-and-after question within a single group, not a randomized comparison of surgery against no surgery or another treatment. Consequently, any observed pre-to-post difference would describe change across the two monitoring periods in this group. By itself, that comparison would not separate a surgical effect from other explanations for change over time. The registry record does not report numerical primary outcome results, so the direction and size of any observed change cannot be described.
3. Trial Design
This is a completed, single-group study of patients with thyroid eye disease who require orbital decompression because of orbital congestion. The registry lists an enrollment of 10. Allocation is recorded as not applicable, and masking is recorded as none. The study is not described as a randomized comparison, and the registry record explicitly indicates that its arms are not a like-for-like control comparison.
The stated objective is to characterize intraocular pressure patterns before and after orbital decompression surgery. Each subject is described as wearing the SENSIMED Triggerfish device for 24h. The brief summary describes continuous monitoring with a contact-lens embedded sensor and says that monitoring is intended to compare patterns before and after decompression. The primary outcome timeframe is also 24 hours.
The primary outcome is titled as a change in IOP before and after surgery. Its description specifies a comparison of SENSIMED Triggerfish output during the transition from wake to sleep before and after orbital decompression. The outcome is expressed in mVEq, identified in the registry as the SENSIMED Triggerfish output unit. The listed summary measure is the median, with standard deviation as the listed measure of dispersion.
The registry record does not report a separate untreated group, a sham procedure, or another comparator. It also does not describe the timing between surgery and each monitoring session, the procedures used to ensure comparable monitoring conditions, or whether every enrolled participant contributed measurements at both time points. These details are not reported in the registry record and should not be inferred from the single-group description.
The record lists thyroid eye disease as the condition and SENSIMED Triggerfish as the device intervention. The study status is completed. The registry record does not report numerical findings for the primary outcome, and it contains no recorded statistical analyses. Thus, the design and intended comparison can be described, but the observed pre-to-post outcome cannot be quantified from the registry record.
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 | SENSIMED Triggerfish |
|---|---|
| STARTED | 10 |
| COMPLETED | 10 |
| NOT COMPLETED | 0 |
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 | SENSIMED Triggerfish |
|---|---|---|
| Participants analysed | 10 | |
| Age, Continuous | years | 61.8 (SD 21.6) |
| Sex: Female, Male: Female | Participants | 9 |
| Sex: Female, Male: Male | Participants | 1 |
| Region of Enrollment: United States | participants | 10 |
| Tolerability of CLS | units on a scale | 1.5 (SD 0.7) |
6. Primary Endpoint
The registry lists the primary outcome as Change in IOP Before and After Orbital Decompression Surgery, measured over 24 hours.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Standard Deviation |
| Unit | mVEq (Sensismed Triggerfish output unit) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is described as a change in SENSIMED Triggerfish output before and after orbital decompression surgery. More specifically, the registry identifies the measurement of interest as the device output during the transition from wake to sleep, with monitoring over a 24-hour period. The output unit is mVEq, identified as the SENSIMED Triggerfish output unit. The registry lists the median as the summary measure and standard deviation as the measure of dispersion.
The clinical rationale is to investigate whether the pattern of the sensor output changes after surgery intended to make more space within the orbit. Continuous monitoring is intended to characterize a pattern over time rather than rely only on a single measurement. Focusing on the wake-to-sleep transition defines the particular part of the monitoring period used for the primary question.
The outcome should be understood as the device’s reported output, not as a value expressed in a conventional pressure unit. The registry does not report a conversion from mVEq to another unit or a threshold for interpreting a change as clinically important. It also does not report the observed median, its variability, a pre-to-post contrast, or an uncertainty interval. Therefore, the endpoint’s intended measurement can be described, but neither its observed value nor the precision of an estimated change is available in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study’s intended comparison but does not provide the numerical result needed to estimate the observed change. No pre-surgery or post-surgery median, difference between those measurements, standard deviation value, confidence interval, or p-value is reported in the record. The recorded number of analyses is 0. As a result, the direction, magnitude, and statistical precision of the primary outcome cannot be assessed from this information.
The design is a single-group before-and-after comparison. If results were available, the primary estimate would describe how the specified sensor output during the wake-to-sleep transition differed between monitoring before and after surgery among the participants contributing measurements. Such a contrast is not equivalent to comparing surgery with an untreated control group. Changes over time, changes in measurement conditions, or other differences between monitoring periods could also contribute to a pre-to-post contrast. The registry record does not provide information that would distinguish these possibilities.
The endpoint uses a device output measured in mVEq. Its interpretation is therefore tied to the SENSIMED Triggerfish output as defined in the record. No calibration relationship or clinically meaningful change threshold is reported. A difference in this output should not be translated into a difference in another pressure unit or into a clinical conclusion without supporting information that is not present in the registry record.
In general, an estimate describes the observed contrast, while an uncertainty interval indicates how precisely that contrast has been estimated under the analysis assumptions. A p-value addresses compatibility of data with a specified statistical null model; it does not quantify the size or practical importance of an effect. These general distinctions matter for a small single-group study, but the registry record contains no estimate, interval, or p-value to interpret.
The record lists 10 as the enrollment, but enrollment alone does not establish how many participants had usable paired monitoring data. The registry record does not report an analysis population, missing measurements, exclusions, or the handling of incomplete monitoring. It is therefore not possible to establish the amount of information behind any planned comparison from the record.
The appropriate reading is consequently limited: the registry describes a pre- and post-surgery monitoring question, but it does not report the numerical primary result or its analysis. No conclusion about the observed pattern or its precision follows from the design description alone.
9. Statistical Methods Explained
The registry record names the endpoint and descriptive summary measures, but it does not report the statistical analysis used to compare the pre-surgery and post-surgery measurements. It lists the median as the endpoint parameter and standard deviation as the dispersion measure. Those labels describe intended summaries; they do not, on their own, specify a statistical test, model, or method for estimating a pre-to-post change.
What does the median describe?
In general, the median is a measure of the center of a set of observations. It is less affected by unusually high or low values than the arithmetic mean. For a sensor output observed over time, a median can summarize the central level of the observations included in the calculation. Its meaning depends on which observations are included and how they are grouped or summarized. The registry record does not specify the data-processing rules used to obtain the primary median, including the handling of repeated measurements within a monitoring period.
What does standard deviation describe?
In general, standard deviation describes the spread of observations around their mean. It is not the same as the uncertainty in an estimated median or in a pre-to-post contrast. The record lists standard deviation as the dispersion measure but does not state exactly which values it describes, such as participant-level summaries or repeated sensor readings. Without that detail, the reported label cannot establish the unit of analysis or the precise interpretation of the variability.
How would a pre-to-post comparison be interpreted?
In general, paired data methods use the fact that measurements from the same participant are related. A paired contrast compares the within-participant change rather than treating pre-surgery and post-surgery observations as independent groups. This can account for stable differences between participants, but it does not by itself control for other changes that occur between monitoring periods. The registry describes a before-and-after objective, but does not report whether the analysis used paired contrasts, a repeated-measures model, or another approach.
Repeated sensor observations also require attention to their temporal structure. In general, readings close together in time may be more alike than readings taken farther apart. Treating every reading as independent when observations are correlated can make uncertainty appear smaller than it is. Methods that account for within-person correlation can address this issue, but the registry record does not identify the approach used, the sampling schedule, or any data-reduction procedure. No particular model can therefore be attributed to this study from the registry description.
What would an uncertainty interval add?
In general, a confidence interval gives a range of estimates compatible with the observed data and the method’s assumptions. Its width conveys precision: a narrower interval indicates greater precision under those assumptions, while a wider interval indicates more uncertainty. A confidence interval does not establish that a result is clinically important, and it does not guarantee that the true value lies within the reported interval. The registry record does not report a confidence interval for the primary outcome.
A p-value, in general, measures how unusual data would be under a stated null model and its assumptions. It does not give the probability that the null hypothesis is true, and it does not measure the magnitude of a change. The registry record lists no analyses and reports no p-value. It also does not report a statistical analysis plan, significance threshold for the primary analysis, or adjustment strategy.
The record includes a planning illustration based on an observed effect and describes assumptions for that illustration: a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect specified as a fraction of the observed effect. It states that the illustration is not the trial’s own design. These assumptions should not be mistaken for the study’s reported analysis plan. In particular, an equal-allocation, two-arm illustration is not a description of the registered single-group before-and-after design. No numerical planning results or observed effect estimate are reported in the registry record, so the illustration cannot be independently interpreted from this information.
Planning sample sizes are hypothetical quantities calculated under assumptions. In general, they describe a design scenario rather than the study’s observed precision. They are not observed power and do not substitute for a confidence interval around a measured effect. The registry record does not report a sample-size justification for the study itself.
The outcome data are device output in mVEq. Statistical analysis can summarize that output, but a statistical calculation cannot establish a conversion to another measurement scale or a clinical threshold unless those are defined and supported. Neither is reported in the registry record. The statistical methods used to derive the stated endpoint and compare the monitoring periods are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies a primary outcome concerning change in SENSIMED Triggerfish output before and after orbital decompression, and it lists IOP patterns as a secondary outcome. It also records 3 outcome measures, but detailed definitions for each measure are not reported in the registry record. No statistical analysis is recorded. The relationship among the measures and the analyses planned for them are therefore unclear.
In general, testing several outcomes or several contrasts can increase the chance of finding an apparently notable result by chance. A multiplicity strategy may define a primary hypothesis, adjust a threshold, or otherwise control interpretation across related analyses. The registry record does not report whether multiplicity was considered, whether the primary outcome had a prespecified analysis, or whether any secondary analyses were intended to be confirmatory or exploratory.
The registry record also does not describe missing-data procedures or an analysis population. It does not say whether all enrolled participants contributed measurements at both time points, how incomplete 24-hour monitoring was handled, whether any measurements were excluded, or how an analysis would treat unavailable outcome values. Enrollment of 10 does not establish the number included in a paired analysis.
These omissions limit interpretation independently of the missing numerical results. Without a defined analysis population, outcome processing rules, missing-data approach, and multiplicity plan, a reader cannot determine which observations would contribute to an estimate or how its uncertainty should be interpreted. Those details are not reported in the registry record.
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 |
|---|---|---|---|
| SENSIMED Triggerfish | 0 | 10 | 0.0% |
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 |
|---|---|
| SENSIMED Triggerfish | 10 of 10 |
Most frequent non-serious adverse event terms
| Event term | Organ system | SENSIMED Triggerfish |
|---|---|---|
| Mild hyperemia and palpebral conjunctiva | Eye disorders | 10 of 10 |
| Mild blurred vision | Eye disorders | 5 of 10 |
| Superficial Punctate keratitis | Eye disorders | 2 of 10 |
The registry lists a SENSIMED Triggerfish group with 10 participants at risk for serious adverse events and 0 affected by serious adverse events. It lists 10 participants at risk for other adverse events and 10 affected by other adverse events. These are the adverse-event counts entered in the registry record.
The serious adverse event figure should be read as a count recorded for this group, not as evidence that the device or surgery is free of risk. The registry record does not identify serious adverse event terms; the listed serious-event terms are empty. It also does not provide descriptions, severity grades, timing, or attribution for the other adverse events. The count of other affected participants therefore does not establish what types of events occurred or whether they were related to the device, monitoring, surgery, or another cause.
The death field is recorded as null. A death count is not reported in the registry record. It should not be interpreted as a reported count of zero. The registry record also does not explain the adverse-event collection period or the rules used to classify and report events. These limitations mean the counts can be described as entered, but they cannot support a detailed safety profile or a causal assessment.
12. What the Result Does, and Does Not, Mean
The study addresses an important measurement question in thyroid eye disease: how continuous SENSIMED Triggerfish output during a 24-hour monitoring period compares before and after orbital decompression. The registry gives the rationale, identifies the intended wake-to-sleep comparison, and describes the device output unit. It does not report the primary outcome values or a statistical analysis, so the observed result cannot be characterized.
The registry record does not establish whether the output increased, decreased, or remained similar after surgery. It does not quantify a change, report uncertainty around a change, or indicate whether any difference met a prespecified statistical or clinical criterion. The absence of a recorded result is not evidence that there was no change; it means the result is not reported in the registry record.
Even if a pre-to-post difference were reported, the single-group design would describe change across the monitoring periods rather than isolate a causal effect of surgery. Without a separate control group, other differences between periods could contribute to the observed contrast. The record also does not report enough information about measurement completion or analysis methods to judge how those issues were handled.
The study’s sensor endpoint is measured in mVEq. The record does not provide a conversion to a conventional pressure scale or a threshold for clinical importance. Therefore, the device output should not be interpreted as a direct numerical estimate in another unit, and the registry does not support a clinical recommendation.
The bounded conclusion is that the registry describes a completed, single-group study designed to examine pre- and post-decompression patterns using continuous monitoring. It does not report numerical primary findings, the statistical analysis, or sufficient details to determine the precision and robustness of a result. The clinical question remains unanswerable from the registry record alone.
13. Why This Trial Matters Statistically
This study is statistically notable because it asks about a pattern over time rather than a single measurement. Continuous monitoring can capture variation across a 24-hour period, while the primary outcome focuses on the transition from wake to sleep. That framing makes the definition of the analyzed observations especially important: the summary depends on how time points are processed and how repeated readings are represented.
The before-and-after design also illustrates the distinction between observing change and attributing change to an intervention. A within-person comparison can account for stable differences between participants, but without a separate control group it cannot by itself distinguish the effect of surgery from other changes between monitoring periods. The registry record identifies the design but does not report the analysis used to address paired observations or time-dependent measurement structure.
The endpoint is a device output in mVEq rather than a value reported in another pressure unit. This is a reminder that statistical precision and measurement interpretation are separate questions. An estimate can be precise on the device’s scale while still requiring validation and context before it can be related to another scale or a clinical threshold. The registry record reports neither a conversion nor a threshold.
Finally, the registry record lists the study as completed but does not report numerical primary results or a statistical analysis. This makes transparent reporting of estimates, uncertainty, analysis populations, and outcome handling particularly important for interpretation. The record supports understanding the question and design, but not the size or precision of an observed change.
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 most immediate limitation for interpreting the study is that the registry record does not report numerical primary outcome results or an analysis. The observed pre-to-post change, its variability, and its uncertainty are therefore unavailable. The record lists 0 analyses, so no statistical result can be evaluated from the registered information.
The single-group before-and-after design has no separate control group. A comparison across monitoring periods could reflect surgery, but it could also reflect other differences between the periods. The registry does not describe timing between surgery and monitoring, whether conditions were standardized, or how potential period effects were considered.
The record does not report whether all enrolled participants contributed complete measurements before and after surgery. It gives no analysis population, exclusions, missing-data approach, or rules for incomplete device recordings. It also does not specify how continuous sensor readings were reduced to the endpoint summary or how dependence among repeated readings was handled.
Outcome interpretation is limited by the device scale. The endpoint is expressed in mVEq, and the registry record does not report a conversion to another pressure unit or a clinically meaningful threshold. The record also does not provide detailed definitions for all outcome measures or a statistical analysis plan, including treatment of multiple outcomes.
Finally, the registry lists 10 enrolled participants. This is a small study enrollment as recorded, but the number with usable paired data is not reported in the registry record. The findings’ precision and applicability beyond the described group cannot be assessed without outcome data and more information about participant characteristics and analysis.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Twenty-four Hour Intraocular Pressure Patterns in Patients With Uncontrolled Thyroid Eye Disease — NCT01798966.
- Registry record last updated 2016-03-11; status last verified 2016-02.
- Results first posted 2015-03-02.
- 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.
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18. Record Summary
The record describes a completed, single-group study of patients with thyroid eye disease undergoing orbital decompression. It lists an enrollment of 10, no masking, and no randomized allocation. The SENSIMED Triggerfish device is described as being worn for 24h.
The primary question concerns change in device output during the wake-to-sleep transition before and after surgery. The endpoint is expressed in mVEq, with the median listed as the summary measure and standard deviation as the dispersion measure. IOP patterns are listed as a secondary outcome.
The registry record does not report numerical primary outcome results, a statistical analysis, or detailed information about missing data and analysis populations. It records 0 analyses. Safety entries list 0 affected by serious adverse events and 10 affected by other adverse events; the death count is not reported in the registry record. The design and intended question are described, but the observed outcome and its precision cannot be assessed from this record.