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 Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs (NCT03733730), a non-randomized na study. The primary outcome is Rate of Eyes With Post-Surgical Intraocular Inflammation - By Eye - Cohort 2.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03733730 |
| Phase | NA |
| Condition | Aphakia, Presbyopia, Astigmatism |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 2449 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Alcon Research |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned people undergoing cataract surgery with attempted implantation of an ACRYSOF IQ RESTOR Toric or ACRYSOF IQ RESTOR IOL in the US. The conditions listed are aphakia, presbyopia and astigmatism. The primary safety outcome was defined for Cohort 2 and used a Safety Analysis Set that excluded one site because of noncompliance with GCP. The registry record describes that excluded site as involving 35 subjects and 60 eyes.
Intervention
The devices included ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL, ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL, and ACRYSOF IQ RESTOR +2.5 D Multifocal IOL, used during cataract surgery. Cohort 2 included implantation of the +3.0 D Multifocal Toric IOL or the +2.5 D Multifocal IOL in at least one eye.
Comparator
There was no randomized control group. The registry describes two cohorts defined by the lenses implanted and the period of implantation. Cohort 1 received specified toric lenses from November 2018 through July 2020; Cohort 2 received the specified +3.0 D toric or +2.5 D multifocal lens after July 2020. These cohorts are not a like-for-like control comparison.
Primary question
The primary safety question was how often post-surgical intraocular inflammation occurred per 1000 implants in each eye in Cohort 2. The registry defines inflammation using graded aqueous-cell findings at different postoperative times, through 180 days after implantation. It states that no formal safety hypothesis was pre-specified for this outcome. The actual primary event rate is not reported in the registry record.
This is a post-approval active surveillance question, not a randomized test of comparative efficacy. It asks for a frequency of a specified safety event following implantation in routine study settings. The outcome is restricted to Cohort 2, so it does not directly estimate the same outcome for both cohorts or establish whether one device is safer than another.
3. Trial Design
This was a prospective, multicenter, post-approval active surveillance study sponsored by Alcon Research. The registry lists the study as completed, with enrollment of 2449. Its start date was 2018-11-27 and its primary completion date was 2022-10-14. The phase is listed as NA. Allocation was non-randomized, masking was none, and the model was parallel.
The two cohorts were formed according to the implanted lens and timing. Cohort 1 included implantation of an ACRYSOF IQ RESTOR Multifocal Toric IOL (+3.0 D or +2.5 D) in at least one eye during cataract surgery, from November 2018 through July 2020. Cohort 2 included implantation in at least one eye of an ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL or an ACRYSOF IQ RESTOR +2.5 D Multifocal IOL after July 2020. The registry also lists cataract surgery as an intervention.
Because allocation was not randomized, membership in the cohorts was not assigned by chance. Their different lens descriptions and implantation periods also mean that the cohorts should not be treated as interchangeable groups in a causal comparison. The registry explicitly cautions that the arms are not a like-for-like control comparison. The study's stated purpose was to report the rate of post-surgical intraocular inflammation within a 180-day postoperative period following attempted implantation in the US.
The primary outcome was specified for Cohort 2 only. The record does not describe a formal safety hypothesis for that outcome, and it does not report a primary event-rate estimate. Further details about site procedures, enrollment criteria, or a protocol-level sample-size justification are not reported in 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.
Before assignment: Cohort 1: Of the 478 enrolled, 25 subjects discontinued prior to attempted implantation. Cohort 2: Of the 1971 enrolled, 144 subjects discontinued prior to attempted implantation. This reporting group includes all enrolled subjects/eyes with attempted implantation (453/706 in Cohort 1) (1827/3417 in Cohort 2).
Overall Study
| Stage | Cohort 1 | Cohort 2 |
|---|---|---|
| STARTED | 453 | 1827 |
| First Eye Attempted Implantation | 453 | 1827 |
| First Eye Successful Implantation | 453 | 1827 |
| Second Eye Attempted Implantation | 453 | 1827 |
| Second Eye Successful Implantation | 453 | 1827 |
| Safety Analysis Set | 453 | 1827 |
| COMPLETED | 451 | 1778 |
| NOT COMPLETED | 2 | 49 |
Reasons for not completing this period:
| Reason | Cohort 1 | Cohort 2 |
|---|---|---|
| Lost to Follow-up | 1 | 32 |
| Other | 1 | 0 |
| Adverse Event | 0 | 4 |
| Death | 0 | 5 |
| Withdrawal by Subject | 0 | 8 |
Analysis population for the primary outcome, as defined in the registry: Safety Analysis Set, minus one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
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: Safety Analysis Set. Cohort 2 excluded one site (35 subjects/60 eyes) due to noncompliance with GCP as previously communicated with the FDA.
| Characteristic | Unit | Cohort 1 | Cohort 2 | Total |
|---|---|---|---|---|
| Participants analysed | 453 | 1792 | 2245 | |
| Age, Customized: Less that 65 years | participants | 148 | 432 | 580 |
| Age, Customized: Equal to or greater than 65 years | participants | 305 | 1360 | 1665 |
| Sex: Female, Male: Female | Participants | 274 | 1150 | 1424 |
| Sex: Female, Male: Male | Participants | 179 | 642 | 821 |
| Race/Ethnicity, Customized: White | participants | 336 | 1387 | 1723 |
| Race/Ethnicity, Customized: Black or African American | participants | 28 | 266 | 294 |
| Race/Ethnicity, Customized: American Indian or Alaska Native | participants | 1 | 14 | 15 |
| Race/Ethnicity, Customized: Asian | participants | 83 | 88 | 171 |
| Race/Ethnicity, Customized: Native Hawaiian or Other Pacific Islander | participants | 0 | 6 | 6 |
| Race/Ethnicity, Customized: Multi-Racial | participants | 2 | 2 | 4 |
| Race/Ethnicity, Customized: Other | participants | 3 | 29 | 32 |
6. Primary Endpoint
The registry lists the primary outcome as Rate of Eyes With Post-Surgical Intraocular Inflammation - By Eye - Cohort 2, measured over Day 90 to 180 post implantation, each eye. The second eye was implanted within 20 days of the first eye..
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | event rate per 1000 implants |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the rate of eyes with post-surgical intraocular inflammation, by eye, in Cohort 2. It is expressed as events per 1000 IOL implants. The registry states that the rate is calculated as the total number of reported events divided by the total number of implants, multiplied by 1000. The denominator is therefore implants, while the outcome is described at the eye level.
Inflammation is defined by specified aqueous-cell findings after implantation: at least 3+ within the first 14 postoperative days; at least 2+ after 14 days and no later than 60 days; or at least 1+ after 60 days. The case definition is described as applying within 180 days after implantation. The registry labels the measurement timeframe as Day 90 to 180 post implantation, each eye, and says the second eye was implanted within 20 days of the first eye. The record does not explain how the stated timeframe and the case-definition windows are reconciled operationally.
A per-implant rate provides a standardized descriptive measure of how frequently the specified event was reported relative to the number of implants. It is suitable for summarizing surveillance data, but by itself does not establish a causal relationship or compare treatments under randomized conditions. The primary event rate and its precision are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry defines a clinically specific safety outcome: post-surgical intraocular inflammation based on graded aqueous-cell findings and postoperative timing. It specifies a per-1000-implant scale and restricts this primary outcome to Cohort 2. However, the registry record does not report the primary event count, the number of implants used for that outcome, the calculated event rate, or a confidence interval. The outcome definition and calculation formula alone do not reveal how often the event occurred.
The study's overall enrollment is 2449, but that figure should not be substituted for the primary outcome denominator. The primary analysis population is described as a Safety Analysis Set minus one site, involving 35 subjects and 60 eyes because of GCP noncompliance. The record does not state the final number of implants contributing to the primary outcome. The adverse-event group sizes are also not a replacement for that denominator: they are reported for different safety groupings, and the second-eye groups have different numbers at risk from the first-eye groups.
The design supports descriptive safety surveillance, not an unconfounded comparison of the cohorts. Allocation was non-randomized, and the cohorts differ in their lens definitions and implantation periods. Changes over time or differences in who received each lens could complicate a direct comparison; the registry does not report an adjusted analysis to address such factors. The record itself warns that the arms are not a like-for-like control comparison. No causal conclusion about relative safety follows from cohort membership alone.
Other registered outcomes include rates of toxic anterior segment syndrome, acute and chronic postoperative endophthalmitis, and uncategorized post-surgical intraocular inflammation. These are listed for Cohort 2, by eye and for overall eyes. Their outcome labels do not supply event estimates in the registry record. The listed serious adverse-event figures provide additional safety context, but they are organized by treatment period and event grouping and are not the primary endpoint result.
No formal safety hypothesis was pre-specified for the primary outcome. The registry record lists no analysis entries, and it does not report a confidence interval or a hypothesis-test result for the primary rate. Consequently, the precision of that estimate cannot be assessed from the posted results. A numerical rate without an interval would describe frequency but would leave uncertainty less fully characterized; in this case, the rate itself is also not reported.
The sample-size assumptions described for planning illustrations are not evidence of observed power and do not establish that the study was prospectively designed to detect a particular effect. They are described as illustrations based on an observed effect, with two-sided significance level 0.05, equal allocation, and a normal approximation, and they use a stated fraction of the observed effect. The registry does not report a protocol sample-size justification for the surveillance study. These planning assumptions do not fill the gap in the primary outcome reporting.
9. Statistical Methods Explained
What does an event rate per 1000 implants mean?
In general, a rate on a per-1000 scale expresses the observed event count relative to the number of relevant implants, rescaled to a common unit. The registry's stated calculation uses reported events and total implants. This standardization can make a frequency easier to interpret when the number of implants differs across settings. It does not change the underlying count, and it does not by itself adjust for differences among participants, eyes, sites, or clinical circumstances.
The unit matters. This endpoint is described as by eye, but its denominator is implants. A person may contribute more than one eye, and the registry notes that a second eye was implanted within 20 days of the first eye. Outcomes from two eyes in one person may be related rather than statistically independent. The record does not explain whether or how any within-person dependence was accounted for. Since the primary rate and its analysis details are not reported, the impact of that issue cannot be evaluated from the registry record.
How is the case definition applied?
The event definition uses aqueous-cell grades at different postoperative periods: a higher threshold in the first 14 days, a lower threshold after 14 days through 60 days, and a further lower threshold after 60 days. This type of time-dependent definition recognizes that the interpretation of a finding can depend on when it occurs. It also makes clear why the timing of examination and event classification matters. The record describes these criteria as the definition of inflammation within 180 days, while separately labeling the endpoint timeframe Day 90 to 180 post implantation. The practical handling of that difference is not reported in the registry record.
In general, a prespecified definition can improve consistency by giving sites a common rule for classifying events. Its value depends on consistent ascertainment and complete follow-up. The registry identifies the definition but does not report details such as assessment schedules, adjudication procedures, or how ambiguous cases were resolved. Such procedures should not be assumed.
What can a confidence interval add?
In general, a confidence interval describes statistical uncertainty around an estimated quantity under the assumptions of the method used. For a safety rate, it helps distinguish the point estimate from the range of values compatible with the data and method. A narrow interval usually indicates greater precision than a wide interval; neither the interval nor the point estimate alone establishes causality. The registry record does not report a confidence interval for the primary endpoint, so its precision cannot be described numerically.
For rare safety events, small changes in event counts can have a noticeable effect on an estimate, and uncertainty may remain even when a rate is expressed on a standardized scale. The actual primary count and denominator are not reported, so no estimate of that uncertainty can be made. A general explanation of rate estimation cannot substitute for the missing study-specific result.
What does the non-randomized structure imply?
In general, random allocation helps balance measured and unmeasured characteristics across comparison groups, on average. This study was non-randomized. Its cohorts were defined by lens and implantation period, rather than random assignment, and the registry states that they are not a like-for-like control comparison. Therefore, differences between their observed outcomes, if reported, could reflect cohort composition, timing, care practices, or other factors as well as any device-related differences. No adjusted comparative result is reported in the registry record.
The study's stated purpose is surveillance after approval. A descriptive event rate can characterize events reported among the observed implants, but it does not answer the same question as a randomized comparative trial. The absence of masking is also recorded; the registry does not provide enough detail to determine how this affected event ascertainment or reporting.
How should planning illustrations be understood?
In general, sample-size calculations describe the amount of information a hypothetical design might need under specified assumptions. They are not observed results. The planning assumptions described for this study use a two-sided significance level of 0.05, equal allocation, a normal approximation, and an effect defined as a stated fraction of the observed effect. The registry's description identifies these as planning illustrations computed from the observed effect, not as the trial's own design assumptions. Participants per arm are the stated quantity for non-time-to-event illustrations; time-to-event illustrations use total events.
These calculations should not be interpreted as observed power. Observed power is not a substitute for reporting an estimate and its uncertainty, and a planning illustration does not show that the original surveillance study was designed to test a particular hypothesis. The record does not report the protocol's sample-size justification. The primary endpoint also has no reported event-rate estimate in the registry record, which limits interpretation of any planning value in relation to that specific endpoint.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 10 outcome measures and several secondary safety outcomes, including rates of toxic anterior segment syndrome, acute postoperative endophthalmitis, chronic postoperative endophthalmitis, and uncategorized post-surgical intraocular inflammation. Several are described by eye and for overall eyes. Considering multiple outcomes can create a multiplicity issue when statistical tests are used to support claims: the chance of at least one apparently notable result may increase as more tests are performed. In general, prespecified testing strategies or adjustment methods can address that issue. The registry record does not report a multiplicity adjustment or a detailed testing hierarchy.
No formal safety hypothesis was pre-specified for the primary endpoint. The registry record lists no analysis entries. It does not report a statistical analysis plan, hypothesis-testing procedure, confidence interval method, or interim analysis. These items are not reported in the registry record; their absence from the public record does not establish what may have been planned elsewhere.
The outcome population is described as the Safety Analysis Set minus one site due to noncompliance with GCP, involving 35 subjects and 60 eyes. The record does not explain how missing observations were handled, whether follow-up completeness was assessed, or how implants without the necessary outcome assessment were treated. It also does not provide a full accounting of participants or implants included in the primary endpoint denominator. Those omissions matter because an event rate depends on both the event count and the population contributing information.
In general, missing-data handling should be described because incomplete observation can affect estimates, especially if missingness is related to outcome status. No missing-data method or sensitivity analysis is reported in the registry record. The noted site exclusion is a population decision, but it does not by itself explain the handling of any other incomplete data.
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 |
|---|---|---|---|
| Cohort 1 Pretreatment | 0 | 453 | 0.0% |
| Cohort 1 Ocular - First Eye | 4 | 453 | 0.9% |
| Cohort 1 Ocular - Second Eye | 6 | 253 | 2.4% |
| Cohort 1 Systemic | 8 | 453 | 1.8% |
| Cohort 2 Pretreatment | 5 | 1827 | 0.3% |
| Cohort 2 Ocular - First Eye | 27 | 1827 | 1.5% |
| Cohort 2 Ocular - Second Eye | 17 | 1590 | 1.1% |
| Cohort 2 Systemic | 28 | 1827 | 1.5% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Cohort 1 Pretreatment | 0 of 453 |
| Cohort 1 Ocular - First Eye | 0 of 453 |
| Cohort 1 Ocular - Second Eye | 0 of 253 |
| Cohort 1 Systemic | 0 of 453 |
| Cohort 2 Pretreatment | 0 of 1827 |
| Cohort 2 Ocular - First Eye | 0 of 1827 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Cohort 1 Pretreatment | 2 of 453 |
| Cohort 1 Ocular - First Eye | 71 of 453 |
| Cohort 1 Ocular - Second Eye | 31 of 253 |
| Cohort 1 Systemic | 0 of 453 |
| Cohort 2 Pretreatment | 0 of 1827 |
| Cohort 2 Ocular - First Eye | 0 of 1827 |
Most frequent serious adverse event terms
| Event term | Organ system | Cohort 1 Pretreatment | Cohort 1 Ocular - First Eye | Cohort 1 Ocular - Second Eye | Cohort 1 Systemic | Cohort 2 Pretreatment | Cohort 2 Ocular - First Eye |
|---|---|---|---|---|---|---|---|
| Intraocular lens repositioning | Surgical and medical procedures | 0 of 453 | 1 of 453 | 1 of 253 | 0 of 453 | 0 of 1827 | 7 of 1827 |
| Vitrectomy | Surgical and medical procedures | 0 of 453 | 0 of 453 | 0 of 253 | 0 of 453 | 0 of 1827 | 8 of 1827 |
| Cataract operation complication | Injury, poisoning and procedural complications | 0 of 453 | 0 of 453 | 1 of 253 | 0 of 453 | 0 of 1827 | 6 of 1827 |
| Lens extraction | Surgical and medical procedures | 0 of 453 | 0 of 453 | 0 of 253 | 0 of 453 | 0 of 1827 | 6 of 1827 |
| Cystoid macular oedema | Eye disorders | 0 of 453 | 1 of 453 | 1 of 253 | 0 of 453 | 0 of 1827 | 3 of 1827 |
| Device dislocation | Product Issues | 0 of 453 | 0 of 453 | 1 of 253 | 0 of 453 | 0 of 1827 | 4 of 1827 |
| Corneal operation | Surgical and medical procedures | 0 of 453 | 2 of 453 | 1 of 253 | 0 of 453 | 0 of 1827 | 2 of 1827 |
| Punctate keratitis | Eye disorders | 0 of 453 | 2 of 453 | 1 of 253 | 0 of 453 | 0 of 1827 | 0 of 1827 |
| Retinal operation | Surgical and medical procedures | 0 of 453 | 0 of 453 | 1 of 253 | 0 of 453 | 0 of 1827 | 2 of 1827 |
| Glare | Eye disorders | 0 of 453 | 0 of 453 | 0 of 253 | 0 of 453 | 0 of 1827 | 2 of 1827 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Cohort 1 Pretreatment | Cohort 1 Ocular - First Eye | Cohort 1 Ocular - Second Eye | Cohort 1 Systemic | Cohort 2 Pretreatment | Cohort 2 Ocular - First Eye |
|---|---|---|---|---|---|---|---|
| Posterior capsule opacification | Eye disorders | 0 of 453 | 31 of 453 | 13 of 253 | 0 of 453 | 0 of 1827 | 0 of 1827 |
| Intraocular pressure increased | Investigations | 0 of 453 | 27 of 453 | 11 of 253 | 0 of 453 | 0 of 1827 | 0 of 1827 |
| Dry eye | Eye disorders | 2 of 453 | 23 of 453 | 11 of 253 | 0 of 453 | 0 of 1827 | 0 of 1827 |
Serious events with the highest arm-level rate: punctate keratitis (0.4%), corneal operation (0.4%), vitrectomy (0.4%), cystoid macular oedema (0.4%), retinal detachment (0.4%).
The registry reports serious and other adverse-event groupings separately for Cohort 1 and Cohort 2, including pretreatment, first-eye, second-eye, and systemic categories. In Cohort 1, serious events affected 0 of 453 in pretreatment, 4 of 453 in the first-eye ocular group, 6 of 253 in the second-eye ocular group, and 8 of 453 in the systemic group. In Cohort 2, the corresponding figures are 5 of 1827 in pretreatment, 27 of 1827 in the first-eye ocular group, 17 of 1590 in the second-eye ocular group, and 28 of 1827 in the systemic group. The systemic Cohort 2 group reports 7 deaths.
These are group-specific figures, not a single overall rate. The numbers at risk differ across categories, particularly for second-eye groups, so the counts should not be compared without considering their denominators and definitions. The same person may appear in more than one grouping; the registry does not provide enough information to add these counts into a unique-person total. The record does not attribute the deaths to the device or procedure.
The listed serious-event terms include punctate keratitis, corneal operation, vitrectomy, cystoid macular oedema, retinal detachment, and retinal tear, each reported as 0.4%. These figures provide context about reported safety events, but they are not the primary inflammation rate and do not by themselves establish cause.
12. What the Result Does, and Does Not, Mean
The study addresses a relevant post-approval surveillance question: how frequently a defined form of intraocular inflammation was reported after implantation. Its prospective, multicenter design and explicit case definition provide a framework for collecting and classifying safety events. The registry also identifies a specific analysis population and explains why one site was excluded.
What the posted registry results do not provide is the primary outcome's event count, implant denominator, calculated rate, or confidence interval. That means the actual frequency and precision of the primary outcome cannot be interpreted from the record. A clear definition of an endpoint is not a substitute for its result. Nor can the overall enrollment or adverse-event group sizes be used as a proxy for the missing primary denominator.
The study also does not establish a randomized comparison between lens types. The cohorts are non-randomized, differ in lens descriptions and implantation periods, and are explicitly not described as a like-for-like control comparison. Even if cohort-specific rates were available, a difference would not by itself show that one lens caused a different outcome. The registry does not report an adjusted comparison that might address differences between groups.
The listed adverse-event figures describe serious and other events in distinct safety categories. They can be read as reported counts alongside their group-specific numbers at risk, but should not be collapsed into an overall total or interpreted as attributable events without further information. The registry does not report causal attribution for the deaths.
Accordingly, the record supports an understanding of the study's surveillance design, outcome definition, and reported adverse-event categories. It does not permit a quantitative conclusion about the primary inflammation rate, its precision, or comparative safety. Those conclusions would require study-specific outcome results and sufficient analytical detail, neither of which is reported in the registry record.
13. Why This Trial Matters Statistically
Post-approval surveillance examines safety events after a device has entered clinical use. Statistical interpretation in this setting depends on clearly defining what counts as an event, when it qualifies, and which implants belong in the denominator. This study specifies a graded, time-dependent definition of post-surgical intraocular inflammation and expresses the outcome per 1000 implants. Those choices make the intended measure understandable as a descriptive surveillance endpoint.
The record also illustrates why reporting the result and its precision is essential. A detailed endpoint definition cannot tell readers how many events occurred. Without the event count, denominator, rate, and an uncertainty measure, readers cannot judge either the observed frequency or how precisely it has been estimated. The endpoint is stated for Cohort 2 only, so its scope also needs to be distinguished from the study's overall enrollment and from safety groupings that cover other populations.
The non-randomized cohort structure is another important statistical feature. Cohort membership was tied to lens and implantation period, rather than random assignment. This design can describe observed events, but it does not automatically support causal comparison. The registry's explicit warning that the cohorts are not like-for-like helps prevent readers from treating them as randomized arms.
Finally, the record demonstrates the value of transparent reporting about analysis populations and exclusions. It identifies a site removed from the Safety Analysis Set because of GCP noncompliance and gives the number of subjects and eyes involved. More detail about the outcome denominator, missing observations, and analytic methods would be needed to assess how those decisions affect the estimate. These distinctions are central to reading safety surveillance accurately, rather than treating every reported count as a comparable rate.
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 result is not reported in the registry record. No event count, implant denominator, event rate, or confidence interval is available, so neither the frequency nor precision of the primary endpoint can be evaluated. The record states that the outcome was pre-specified for Cohort 2 only, which limits the scope of any inference to that cohort even if results were available.
The design is non-randomized and the cohorts differ in lens definition and implantation period. The registry cautions that the groups are not a like-for-like control comparison. A direct contrast could therefore be affected by differences in the groups or by changes over time, and the registry record does not report a comparative adjusted analysis.
The primary analysis population excludes one site because of GCP noncompliance, described as 35 subjects and 60 eyes. The record does not report the final primary endpoint denominator or explain how missing observations, incomplete follow-up, or implants without outcome assessment were handled. It also does not report site-level ascertainment or adjudication procedures.
The endpoint description gives a measurement timeframe of Day 90 to 180, while its case definition refers to findings across postoperative windows beginning in the first 14 days and extending beyond 60 days. The registry does not explain how those descriptions work together in implementation. The effect of that ambiguity on case classification cannot be determined from the record.
The record lists no analysis entries and does not report a formal safety hypothesis, multiplicity strategy, or statistical analysis plan. These omissions limit assessment of analytic choices. The adverse-event groupings provide safety context but are not the missing primary endpoint result, and the listed deaths are not attributed to the device or procedure.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs — NCT03733730.
- Registry record last updated 2023-11-01; status last verified 2023-10.
- Results first posted 2023-11-01.
- 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
NCT03733730 is a completed, prospective, multicenter, post-approval active surveillance study sponsored by Alcon Research. The registry lists enrollment of 2449, non-randomized allocation, no masking, a parallel model, and phase NA. Its listed conditions are aphakia, presbyopia, and astigmatism.
The primary outcome is the rate of eyes with post-surgical intraocular inflammation per 1000 implants in Cohort 2, using a specified aqueous-cell case definition. The primary analysis population excludes one site for GCP noncompliance, described as 35 subjects and 60 eyes. The primary event rate and its precision are not reported in the registry record.
The record also lists secondary safety outcomes and serious adverse-event groupings. Because cohort membership was non-randomized and the cohorts are not a like-for-like control comparison, the study should be read as descriptive surveillance rather than a randomized comparative assessment.