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 Evaluation of the Safety and Performance of the HARMONI® Toric Lens (NCT03050697), a na na study. The primary outcome is Number of Eyes With Absolute Rotation of IOL Meridian by Visit.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03050697 |
| Phase | NA |
| Condition | Aphakia, Corneal Astigmatism, Cataract |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 16 |
| Arms in the primary outcome | n/a |
| Lead sponsor | ClarVista Medical |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned subjects with pre-existing corneal astigmatism who needed cataract surgery. The registry lists aphakia, corneal astigmatism and cataract as conditions. Enrollment was 16. The planned rotation analysis population was implanted eyes with successful HMTIOL implantation and data at the visit being assessed; the number meeting that definition at each visit is not reported in the registry record.
Intervention
The intervention was the HARMONI® Modular Toric Intraocular Lens, implanted in the capsular bag after removal of the cataractous lens and intended for lifetime use. The listed procedure was cataract extraction with intraocular lens implantation. The registry describes the study as prospective and multicenter.
Comparator
This was a single-group study. The registry does not list a separate control group, and allocation is recorded as NA. The study therefore does not provide a like-for-like comparison between the lens and another lens or treatment. Results should be read as descriptions of outcomes in the studied group, not as estimates of a comparative treatment effect.
Primary question
The primary outcome was the number of eyes in categories of absolute intraocular lens rotation at specified visits. Lens orientation was assessed with slit-lamp photography, and rotation was defined from the difference between the lens axis on the day of surgery and the axis at a subsequent postoperative visit. The registry lists baseline (Day 0 preoperative), Day 1, Week 1, Month 1 and Month 3. Counts by rotation category and visit are not reported in the registry record.
3. Trial Design
The registry describes a prospective, multicenter, single-group study of the exchangeable ClarVista HARMONI modular toric intraocular lens system. Its stated purpose was to evaluate safety and performance in subjects with pre-existing corneal astigmatism needing cataract surgery. The study is marked completed, with enrollment of 16. Its start date is 2016-09-28 and its primary completion date is 2017-06-07. The phase is recorded as NA.
All participants were assigned the HARMONI® Modular Toric Intraocular Lens intervention in the arm description. The lens was implanted in the capsular bag after cataractous lens removal and was intended for lifetime use. Cataract extraction with intraocular lens implantation is also listed as a procedure. Masking is recorded as none, and allocation is recorded as NA. No separate comparator arm is listed, so the design does not support a direct comparison with an alternative intervention.
The primary outcome concerned the number of eyes in categories of intraocular lens rotation by visit. The planned analysis population was eyes with successful HMTIOL implantation and data at the relevant visit. The registry describes categorical reporting and states that no formal statistical hypothesis testing was planned. Numerical primary outcome results and visit-specific analysis counts are not reported in the registry record.
The record does not report a sample-size justification, an interim analysis plan or a more detailed statistical analysis plan. A planning illustration based on an observed effect is described separately from the trial’s own design; its assumptions do not change the single-group nature of the study. The registry also cautions that the arms are not a like-for-like control comparison. Consequently, interpretation rests on the reported group-level counts and their completeness, rather than on a randomized contrast.
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: Of the 16 subjects (25 eyes) enrolled in the study, 4 subjects (7 eyes) were exited prior to implantation as screen failures, and 1 eye in 1 subject was exited prior to implantation due to a medical condition. This reporting group includes all implanted subjects (12) and eyes (17).
Overall Study
| Stage | HMTIOL |
|---|---|
| STARTED | 12 |
| COMPLETED | 12 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Implanted Eye: All eyes with successful HMTIOL implantation and data at visit
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: All Implanted Subjects
| Characteristic | Unit | HMTIOL |
|---|---|---|
| Participants analysed | 12 | |
| Age, Continuous | years | 69.7 (SD 11.7) |
| Sex: Female, Male: Female | Participants | 6 |
| Sex: Female, Male: Male | Participants | 6 |
| Race/Ethnicity, Customized: Asian | Participants | 0 |
| Race/Ethnicity, Customized: Black | Participants | 0 |
| Race/Ethnicity, Customized: Caucasian | Participants | 10 |
| Race/Ethnicity, Customized: Other | Participants | 2 |
| Region of Enrollment: New Zealand | participants | 12 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Eyes With Absolute Rotation of IOL Meridian by Visit, measured over Baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative, Month 3 postoperative.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | eyes |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the number of eyes with absolute rotation of the intraocular lens meridian by visit. Slit-lamp photography was used to assess lens orientation. Rotation was defined as the difference between the axis of lens orientation on the day of surgery and the axis at a later postoperative visit, and it was measured in degrees before being reported in categories.
The registry lists baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative and Month 3 postoperative as time points. Baseline is part of the stated timeframe, while the rotation definition describes a comparison with a subsequent postoperative visit. The numerical counts for any of these time points are not reported in the registry record.
The record says rotation was planned for categories of ≤ 5°, < 10°, < 20° and < 30°. Instead, it describes reporting in categories of ≤ 5°, > 5° to ≤ 10°, > 10° to ≤ 20° and > 20°. The latter are non-overlapping bands, while the planned thresholds read as cumulative cutoffs. These formats answer different descriptive questions, so the categories should not be treated as interchangeable.
General explanation: categorical reporting can make the distribution of a measured quantity easier to read, but it also hides variation within each band. Without the actual category counts, readers cannot assess how rotation was distributed across eyes or how that distribution changed across visits.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central limitation for interpreting the primary outcome is that the registry record describes how rotation was measured and categorized but does not report the number of eyes in each category at each visit. It is therefore not possible to characterize the observed distribution of rotation, its change over time, or the precision of those findings from the registry results. The study enrollment of 16 does not establish that 16 eyes contributed data at every visit: the planned analysis population required successful implantation and available data at that specific visit, and visit-level counts are not reported.
The registry states that no formal statistical hypothesis testing was planned. Accordingly, the primary outcome is presented as a descriptive count rather than as a test of a prespecified difference. There is no reported estimate, confidence interval or p-value for lens rotation in the registry record. General explanation: a confidence interval conveys the range of values compatible with an estimate under the statistical model; without an estimate and interval, readers cannot judge precision in that way. A count alone, even if available, would also need a clear denominator to indicate how many eyes contributed at the relevant visit.
The study is single-group, with allocation recorded as NA and no separate comparator listed. Its results therefore cannot establish how outcomes compare with another lens or treatment. The record itself cautions that the arms are not a like-for-like control comparison. No relative effect or causal contrast should be inferred from the available design description.
For safety, the registry reports 0 serious nonocular adverse events among 12 at risk and 0 serious ocular adverse events among 17 at risk. It reports 0 deaths in each group. For other adverse events, it reports 0 affected in the nonocular group and 2 affected in the ocular group. These are counts with the listed at-risk denominators, not comparative estimates. The differing at-risk totals are not explained in the registry record, and the ocular at-risk count is larger than the stated study enrollment. The record does not provide enough detail to reconcile those counts or to assess event timing, duration or severity beyond the serious-versus-other grouping.
Overall, the registry describes the study design, endpoint definition and selected safety counts, but does not report the primary rotation outcome values. The available figures support only a limited descriptive reading and do not establish a comparative treatment effect.
9. Statistical Methods Explained
What kind of primary analysis was planned?
The registry defines the primary endpoint as a count of eyes in categories of absolute lens rotation at different visits. It explicitly states that no formal statistical hypothesis testing was planned. This means the stated primary analysis was descriptive: it was intended to report how many eyes fell into each category, rather than test a null hypothesis about a treatment difference. No formal test result is reported.
General explanation: descriptive counts are useful for showing the observed distribution, but they do not by themselves quantify uncertainty or establish that a pattern would recur in another sample. To interpret a count, the denominator matters. Here, the planned analysis population was eyes with successful implantation and data at the visit in question. The numbers of contributing eyes by visit are not reported in the registry record.
How should the rotation categories be read?
Rotation was measured in degrees, using slit-lamp photographs to assess lens orientation. The stated definition compares the lens axis on the day of surgery with the axis at a subsequent postoperative visit. The registry lists baseline (Day 0 preoperative), Day 1 postoperative, Week 1 postoperative, Month 1 postoperative and Month 3 postoperative. It does not report the category counts at those visits.
The record distinguishes the planned categories, ≤ 5°, < 10°, < 20° and < 30°, from the categories actually described for reporting: ≤ 5°, > 5° to ≤ 10°, > 10° to ≤ 20° and > 20°. The reported categories partition values into non-overlapping bands, whereas a set of cumulative thresholds would count values below each cutoff. Those approaches can summarize the same measurement differently. Because the posted counts are not reported in the registry record, no numerical interpretation of the distribution is possible.
General explanation: categorization simplifies a continuous measurement, but reduces detail. Values in the same band may still differ, and a value near a category boundary may be grouped differently from a nearby value on the other side. Reporting the measurement itself or additional distributional summaries can preserve information, but such results are not described in the registry record.
What does the design allow the reader to conclude?
This is a single-group study; allocation is recorded as NA, masking as none, and no comparator group is listed. The registry cautions that the arms are not a like-for-like control comparison. As a result, the design description does not support a randomized comparison or a direct estimate of how the intervention differs from another treatment. General explanation: a control group can help distinguish outcomes associated with an intervention from outcomes that might occur for other reasons, but the record does not describe such a comparison.
The study enrolled 16 participants. That total is not necessarily the denominator for every endpoint or visit. The primary analysis population required successful implantation and data at the visit, and the visit-specific numbers are not reported. The record does not explain how missing measurements were handled or why data might be unavailable.
How should the planning illustration be understood?
The registry describes a planning illustration based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. For time-to-event tables, the stated quantity is the total number of events; for other tables, it is participants per arm. The illustration is explicitly not the trial’s own design. Its assumptions do not imply that this single-group study had two randomized arms, and any sample-size figure is a planning illustration rather than observed power. No planning output is reported in the registry record.
General explanation: a sample-size calculation describes the scale of a hypothetical study under chosen assumptions. It depends on the target effect and statistical method, and it should not be interpreted as evidence that an observed result is likely to be true. “Observed power” is not a substitute for interpreting an estimate and its uncertainty. The planning assumptions described for this study should therefore be kept separate from its actual design and from the unavailable primary outcome counts.
What can be inferred from the safety counts?
The registry reports safety counts by ocular and nonocular group, including the number at risk and the number affected. These are descriptive summaries. General explanation: an at-risk denominator identifies the group in which the event count was assessed; it does not by itself explain how that group was defined or whether all participants contributed. The safety denominators differ from the study enrollment and from each other, and the reason is not reported in the registry record. The counts should be quoted with their listed denominators rather than treated as a direct comparison between groups.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 16 outcome measures and 0 analyses. The primary outcome has several stated visits and multiple rotation categories, but no numerical category counts are reported in the registry record. No inferential results for those visits or categories are described. The record also states that no formal statistical hypothesis testing was planned.
General explanation: when many outcomes, categories or time points are examined, the chance of finding an apparently unusual result can increase if each is tested separately. Multiplicity methods can address that issue when formal testing is planned. Here, the stated descriptive approach and absence of reported analysis results do not allow an assessment of any adjustment strategy. Whether the protocol specified a hierarchy or other multiplicity approach is not reported in the registry record.
The planned analysis population for rotation included eyes with successful HMTIOL implantation and data at the visit being assessed. The number of eyes analyzed at each visit is not reported. The registry does not state how missing measurements, unsuccessful implantations, withdrawals or other unavailable observations were handled. Reasons for missing data and any sensitivity analyses are not reported in the registry record.
The safety summaries use different at-risk counts for ocular and nonocular adverse events. The record does not explain those denominators or how they relate to the enrollment of 16. No subgroup analysis plan or additional detail about analysis populations is reported. General explanation: denominators and missing-data rules matter because the apparent frequency and distribution of outcomes depend on which participants contribute data. Without those details, readers should avoid assuming that every enrolled participant contributed to every result.
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 |
|---|---|---|---|
| HMTIOL - Nonocular AEs | 0 | 12 | 0.0% |
| HMTIOL - Ocular AEs | 0 | 17 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| HMTIOL - Nonocular AEs | 0 of 12 |
| HMTIOL - Ocular AEs | 0 of 17 |
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 |
|---|---|
| HMTIOL - Nonocular AEs | 0 of 12 |
| HMTIOL - Ocular AEs | 2 of 17 |
Most frequent non-serious adverse event terms
| Event term | Organ system | HMTIOL - Nonocular AEs | HMTIOL - Ocular AEs |
|---|---|---|---|
| Astigmatism | Eye disorders | 0 of 12 | 1 of 17 |
| Macular oedema | Eye disorders | 0 of 12 | 1 of 17 |
| Procedural complication | Injury, poisoning and procedural complications | 0 of 12 | 1 of 17 |
| Intra-ocular injection | Surgical and medical procedures | 0 of 12 | 1 of 17 |
| Vitrectomy | Surgical and medical procedures | 0 of 12 | 1 of 17 |
The registry reports 0 serious nonocular adverse events among 12 at risk and 0 serious ocular adverse events among 17 at risk. It also reports 0 deaths in each group. No serious adverse-event terms are listed. For other adverse events, the registry reports 0 affected in the nonocular group and 2 affected in the ocular group.
These figures should be read with their separate at-risk denominators and adverse-event group labels. The record does not explain why the denominators differ or why the ocular at-risk count is larger than the study enrollment of 16. It also does not provide further detail about the two other ocular adverse events in the information described in the registry record. The counts are descriptive, not a comparison between treatments, and do not establish a rate or comparative risk beyond the reported counts and denominators.
General explanation: a zero count means that no affected participants are recorded in that group; it does not, by itself, show that an event is impossible or precisely quantify the underlying risk. Interpretation depends on the denominator, event definitions, follow-up and completeness of ascertainment. Those additional details are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
This study record describes a prospective, multicenter, single-group evaluation of the HARMONI® Modular Toric Intraocular Lens for subjects with pre-existing corneal astigmatism needing cataract surgery. The registry defines an outcome based on the number of eyes in categories of lens rotation over postoperative visits and reports selected safety counts. It also states that no formal statistical hypothesis testing was planned.
The primary rotation counts by category and visit are not reported in the registry record. Consequently, the posted results do not show the observed distribution of rotation, how that distribution varied across visits, or how precise any estimate might be. The study enrollment of 16 should not be substituted for a visit-specific denominator, because the planned analysis population required successful implantation and data at each visit.
The single-group design does not provide a direct comparison with a control treatment. The record cautions that the arms are not a like-for-like control comparison. The findings therefore cannot be read as a comparative treatment effect, and no conclusion about differences from an alternative lens can be drawn from the design described.
The safety information reports zero serious events and zero deaths in the listed ocular and nonocular groups, alongside 2 affected by other ocular adverse events and 0 affected by other nonocular adverse events. The record does not explain the differing at-risk counts or provide further details for the other ocular events. These figures are limited descriptive counts, not a complete assessment of comparative safety.
General explanation: a registry entry can clarify what investigators intended to measure and what was recorded, while still leaving key results or analysis details unavailable. In this case, the endpoint definition and safety counts can be described, but the missing primary outcome values and lack of a comparator constrain interpretation.
13. Why This Trial Matters Statistically
This study is statistically notable for the gap between a clearly described primary measurement and the absence of its numerical results in the registry record. The endpoint definition specifies how lens orientation was assessed, how rotation was defined, which visits were included and which categories were intended. Yet the counts needed to describe the outcome distribution are not reported. Readers can understand the measurement plan but cannot evaluate the reported primary outcome from the registry information described.
The design also matters. This is a single-group study, not a randomized comparison with a control treatment. Allocation is recorded as NA and masking as none. The registry itself warns that the arms are not a like-for-like control comparison. A descriptive study can document outcomes in its enrolled group, but it does not supply the same evidence as a direct comparative design.
The stated analysis population and safety denominators illustrate why denominators need to accompany outcome counts. Rotation analyses were planned for implanted eyes with data at the relevant visit, while safety groups list 12 and 17 at risk. The reasons for the different counts are not reported. Enrollment of 16 alone cannot determine how many observations contributed to each endpoint.
General explanation: statistical interpretation depends not only on the outcome definition, but also on the reported results, denominators, missing-data handling and design. When those elements are incomplete, restraint is more informative than inferring an effect from a study’s purpose or from a small set of safety counts. The registry record is useful for understanding the planned measurement and design, while leaving the central rotation result unassessable.
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 primary outcome is defined in detail, but its numerical counts by category and visit are not reported in the registry record. This prevents readers from assessing the observed rotation distribution or its variation over time. The registry lists 16 enrolled participants, but does not report visit-specific numbers contributing to the primary outcome. Successful implantation and available data at the visit were part of the planned analysis population, so enrollment cannot be assumed to equal the endpoint denominator.
The planned rotation categories differ from the categories described as reported. The planned thresholds were ≤ 5°, < 10°, < 20° and < 30°, while the reported categories were ≤ 5°, > 5° to ≤ 10°, > 10° to ≤ 20° and > 20°. Without the results and further explanation, readers cannot determine how the change in category format was applied to the outcome reporting.
The single-group design has no listed comparator, and masking is recorded as none. The registry does not report a sample-size justification, interim analyses, a detailed statistical analysis plan or a formal hypothesis test; it states that no formal statistical hypothesis testing was planned. Missing-data methods, reasons for unavailable observations and sensitivity analyses are also not reported.
For safety, the record reports at-risk counts of 12 for nonocular events and 17 for ocular events, which differ from each other and from enrollment of 16. The registry does not explain those denominators. It reports 2 affected by other ocular adverse events but does not provide further details in the information described. These limitations restrict both the primary-outcome interpretation and the context available for the safety counts.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation of the Safety and Performance of the HARMONI® Toric Lens — NCT03050697.
- Registry record last updated 2020-06-12; status last verified 2020-06.
- Results first posted 2020-06-11.
- 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
NCT03050697 is a completed, prospective, multicenter, single-group study of the HARMONI® Modular Toric Intraocular Lens for subjects with pre-existing corneal astigmatism needing cataract surgery. Enrollment was 16. Allocation is recorded as NA, masking as none and phase as NA.
The primary endpoint was the number of eyes in categories of absolute lens rotation at listed visits. Rotation was assessed with slit-lamp photography, and the registry states that no formal statistical hypothesis testing was planned. Numerical primary outcome counts and visit-specific analysis denominators are not reported in the registry record.
For safety, the registry reports 0 serious affected and 0 deaths in both the nonocular group (12 at risk) and ocular group (17 at risk). Other adverse events affected 0 in the nonocular group and 2 in the ocular group. The record does not explain the differing at-risk counts. No comparator group is listed, so the results do not provide a direct treatment comparison.