Early Feasibility Study Using IOPCL MAG to Improve Near Vision in ARMD Subjects: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Early Feasibility Study Using IOPCL MAG to Improve Near Vision in ARMD Subjects (NCT04984590), a na phase not stated study. The primary outcome is Tilt of the PCIOL and IOPCL MAG Complex.

2. Clinical Question

The clinical question is framed as an early feasibility evaluation of the device in people with age-related macular degeneration after cataract surgery. The study description says the aim is to improve near vision, while the named primary outcome concerns the tilt of the implanted lens complex. These are different kinds of information: visual acuity is an outcome of visual function, whereas tilt is a postoperative measurement of device position.

The registry lists secondary near-vision measures based on uncorrected or best-corrected near visual acuity, with comparisons to preoperative best-corrected near visual acuity at a different viewing distance and with a +3.0D add. The named thresholds include achieving at least 10 letters or at least 20 letters, with specified proportions of participants. Those outcome definitions describe planned measurements; they do not establish that any threshold was reached. The record does not report the numerical results for these secondary measures, so the magnitude and precision of any visual-acuity changes cannot be assessed from this registry information.

3. Trial Design

This is a completed, single-group early feasibility study of the IOPCL AMD MAG device. The registry lists enrollment of 9 and describes a study population with age-related macular degeneration and a previously implanted Alcon Model SN60WF or Model SA60AT intraocular lens. The earlier lens had to have been implanted at least 6 months before the study device was received. The intervention description states that all subjects receive a 10.0 Diopter intraocular pseudophakic capsular lens magnifier.

Allocation is listed as NA, masking as NONE, and the model as SINGLE GROUP. Accordingly, the record does not describe random assignment or a separate control arm. The comparison is not a like-for-like comparison between randomized groups. The follow-up period in the study description is 12 months, and the primary outcome timeframe is also listed as 12 Months. The primary measure concerns postoperative tilt of the PCIOL and IOPCL MAG complex.

The record lists 8 outcome measures and 0 analyses. Five named secondary outcomes concern near visual acuity, using postoperative uncorrected or best-corrected measurements and comparisons with preoperative best-corrected near visual acuity. The primary endpoint and secondary outcomes have different roles: the primary endpoint is a device-position measure, while the listed secondary measures address near visual acuity. The registry record does not report a protocol, a detailed analysis plan, or results for those outcomes.

The study status is COMPLETED. The registry record gives start and primary completion dates, but completion status alone does not establish that every outcome was measured for every participant or that results were favorable or unfavorable. The record does not report the number of participants who completed follow-up, withdrawals, or the analysis population. Those details are needed to understand how much of the enrolled group contributed to each result.

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

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.

6. Primary Endpoint

The registry lists the primary outcome as Tilt of the PCIOL and IOPCL MAG Complex, measured over 12 Months.

The primary endpoint is titled “Tilt of the PCIOL and IOPCL MAG Complex.” Its unit is eyes, its timeframe is 12 Months, and the outcome description says that postoperative tilt is measured, with tilt defined as less than or equal to 10 degrees. This makes the endpoint a count-type measure rather than a continuous estimate of the tilt angle as described in the registry. The record does not report the observed count or the number of eyes meeting the definition.

A device-position measure can describe whether the implanted lens complex meets a prespecified positional criterion. In general, using a defined threshold makes an outcome interpretable as a count of units meeting that criterion, rather than as a summary of the range of measured angles. The choice of a threshold also discards some detail: measurements on either side of the threshold are categorized differently even if their underlying angles are close. This is a general feature of threshold-based outcomes, not a result about this study.

The endpoint is used alongside near-vision outcomes, but it does not directly measure visual acuity. The registry record does not report how tilt was measured, who assessed it, whether assessors were masked, or the observed endpoint result. It also does not report an analysis comparing tilt with vision. Thus the endpoint definition indicates what was intended to be counted, but the available record does not establish the distribution of tilt or its relationship to visual function.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the design permit?

The registry describes a single-group study with allocation listed as NA and masking listed as NONE. In general, random allocation helps balance known and unknown prognostic factors between treatment groups, while masking can reduce the influence of expectations on measurement or reporting. Neither a randomized comparison nor masking is described. Therefore, the design should not be interpreted as a controlled estimate of treatment effect. A before-and-after comparison, if reported, would describe change over time in the studied group but could not by itself separate the device’s contribution from other changes or influences.

The record does not report whether the outcomes were analyzed using paired methods, how repeated measurements were handled, or what covariates, if any, were included. Those details are not reported in the registry record. Statistical methods should not be inferred from the endpoint titles alone.

What kind of outcome is the primary endpoint?

The primary measure is a count of eyes defined by a positional threshold: postoperative tilt of the PCIOL and IOPCL MAG complex, with tilt defined as less than or equal to 10 degrees. A count endpoint can be reported as the number of units meeting a definition, sometimes alongside a denominator or an estimated proportion. The registry record gives the unit as eyes but does not report the observed count, denominator used in the analysis, or an uncertainty interval. It also does not state how multiple eyes from one participant, if relevant, were handled. That detail is not reported in the registry record.

In general, if a count is converted to a proportion, uncertainty depends on both the number meeting the criterion and the number assessed. A small study can yield imprecise estimates, even if the observed proportion appears high or low. No proportion or interval can be reconstructed from the record because the endpoint result is absent. The registry’s enrollment entry should not be treated as an endpoint denominator without a reported analysis population.

What is the role of the visual-acuity outcomes?

The named secondary measures use letter-based near visual-acuity outcomes. Some compare postoperative uncorrected near visual acuity at 14cm with preoperative best-corrected near visual acuity at 30cm with a +3.0D add; others use postoperative best-corrected near visual acuity. The definitions include thresholds for achieving at least 10 letters or at least 20 letters at specified proportions. These are threshold outcomes: they classify participants according to whether a stated amount of change or performance criterion was achieved. The record does not give the counts or estimates for these outcomes.

In general, reporting only whether a threshold was reached can be easy to interpret, but it can conceal the distribution of values and differences among participants. A continuous or ordinal summary may retain more detail, depending on the measurement scale and analysis. The registry record does not report whether additional summaries were used or how missing visual-acuity measurements were handled.

What can the planning illustration tell a reader?

The record describes a sample-size 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. It says the effect to detect is a stated fraction of the observed effect. The record also distinguishes time-to-event illustrations, which give a total number of events, from other illustrations, which give participants per arm. No planning illustration values are included in the registry record for this explanation, so no sample-size figure can be stated.

In general, such an illustration asks how much information a hypothetical future comparison might require under specified assumptions. It is not the sample size used to demonstrate an observed treatment effect, and it is not observed power. Because this study is single-group, an illustration assuming equal allocation between two arms is not a description of the study’s actual design. The record does not report that these assumptions were the sponsor’s original design assumptions or that the illustration was used to plan this study.

What statistical results are missing?

The registry lists 0 analyses. It does not report a primary endpoint estimate, a treatment effect, a confidence interval, a p-value, or an inferential method. It also does not report a sample-size justification, interim analysis plan, or detailed statistical analysis plan. A p-value, in general, measures how incompatible the observed data are with a specified null model, under the assumptions of the test; it does not measure the size or clinical importance of an effect. Since no p-value or test is reported, neither statistical significance nor nonsignificance can be inferred.

Over-dispersion is a general issue for count data when variability exceeds what a simple count model assumes; it can make model-based uncertainty too small if ignored. The record does not report a count model or enough outcome information to assess over-dispersion. This is a general methodological consideration, not evidence that over-dispersion occurred in this study.

10. Multiplicity, Missing Data and Analysis Populations

The record lists 8 outcome measures, including the named primary tilt endpoint and secondary visual-acuity outcomes, and lists 0 analyses. It does not report a multiplicity adjustment, a hierarchy among secondary outcomes, or a statistical testing plan. Those details are not reported in the registry record.

Multiplicity is a general concern when several outcomes or comparisons are tested. The more questions tested, the greater the chance that at least one result may appear unusual by chance if each test is interpreted separately. Analysts may address this by specifying a primary outcome, controlling error across tests, or treating secondary analyses as exploratory. The registry identifies a primary outcome, but it does not state how the other outcomes were to be interpreted or whether any adjustment was planned. No significance claims can be evaluated because no inferential results are reported.

Missing-data handling is also not reported in the registry record. The record does not state whether there were missing primary or secondary measurements, whether participants withdrew, or how any incomplete follow-up was treated. The study description gives a 12-month follow-up period, but this does not establish that all enrolled participants contributed measurements at that time. The number analyzed for each outcome is not reported.

Analysis populations are not described. In general, an analysis population specifies which participants or observations are included in a particular analysis and how departures from the intended treatment or follow-up are handled. Without such information, the enrollment entry cannot be assumed to equal the analysis denominator for any endpoint. The registry record also does not report whether the primary endpoint was analyzed at the participant or eye level beyond naming eyes as its unit.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry records 0 serious adverse events among 9 at risk in the IOPCL AMD MAG group. It records 1 other adverse event among 9 at risk and 0 deaths. These are counts in the registry’s safety categories; they do not describe the event type, timing, severity details beyond the category, or relationship to the device. The serious-event term list is empty.

These figures should be read as descriptive counts for the recorded group, not as a comparison with another treatment or with an untreated group. The study is single-group, and the registry does not provide a comparator safety rate. A count of 0 serious events in the recorded group does not establish that serious events cannot occur or that the device is safer than an alternative. Likewise, the one other event cannot be attributed to the device from the information reported.

The record does not explain the event definition, the duration of risk observation for each participant, whether the counts are participant-level or event-level, or whether all events were captured. Those details are not reported in the registry record. The stated follow-up period is 12 months, but the safety figures alone do not show the completeness of follow-up. These counts are therefore a limited safety description, not a comparative safety estimate.

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

The registry record establishes that this was a completed, single-group early feasibility study of secondary implantation of the IOPCL AMD MAG in people with age-related macular degeneration after cataract surgery. It records enrollment of 9, describes 12-month follow-up, and specifies a primary positional outcome based on tilt of the PCIOL and IOPCL MAG complex. It also lists secondary near-vision outcome definitions. This information clarifies the questions the study set out to address.

It does not establish the observed result for the primary endpoint. The record does not state how many eyes had tilt less than or equal to 10 degrees at 12 Months. Nor does it report the visual-acuity results, counts reaching the specified letter thresholds, estimates of change, or uncertainty around any estimate. The study’s completion status cannot be used to fill in these missing results, and the absence of results in this record should not be interpreted as a null result.

Even if numerical before-and-after results were available, the single-group design would limit causal interpretation. In general, changes over time in one group may reflect the intervention, measurement conditions, natural variation, or other influences. A separate randomized control group can help distinguish these possibilities, but none is described in this registry record. The registry’s preoperative and postoperative visual-acuity definitions do not create a randomized comparator.

The recorded safety counts are also limited. They report 0 serious events, 1 other event, and 0 deaths, with the listed risk denominators, but give no event descriptions or comparative rates. They cannot establish comparative safety or rule out uncommon harms. Overall, the registry provides design details, outcome definitions, and a small set of safety counts, but lacks the efficacy estimates and analysis details needed to characterize the observed visual or positional outcomes.

13. Why This Trial Matters Statistically

This study is statistically notable for the distinction between its intended clinical aim and its primary measurement. The study description concerns improving near vision, while the primary endpoint is a threshold-based measure of lens-complex tilt. The listed secondary outcomes address near visual acuity more directly. Keeping these outcome types distinct helps readers avoid treating a device-position measure as though it were itself a visual-function result.

The single-group design also matters. In general, uncontrolled feasibility studies can describe device use and outcomes in the group studied, but they cannot provide the same treatment-effect comparison as a randomized controlled design. The absence of a comparator is especially relevant when interpreting changes from preoperative to postoperative measurements: a change over time is descriptive unless the analysis can address alternative explanations. The record does not report such an analysis.

Outcome definitions and statistical results are not interchangeable. The primary tilt criterion and the letter-based visual-acuity thresholds are explicit, but the registry record does not report the measured results. Statistical interpretation requires estimates and their uncertainty, not only an outcome’s name or threshold. With no reported endpoint analyses, readers cannot judge precision, variation, or whether observed results were consistent across participants.

The record also illustrates why feasibility status and completion status should be separated from evidence about efficacy. A study can be completed without its outcome results appearing in the registry record. The listed safety counts contribute a limited descriptive account, but do not offer comparative safety information. For statistical readers, the key contribution of the available record is therefore the definition of the study population, design, and intended measurements, together with a clear indication that outcome estimates and analysis methods are not reported.

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 trial from the registry record is the absence of reported primary and secondary outcome results. The primary endpoint is defined, but its observed count is not reported. Near-vision outcomes are named, but their estimates and threshold-attainment counts are also not reported. Consequently, no magnitude of effect or precision can be assessed.

The single-group design has no separate control arm, and allocation is listed as NA. This limits causal comparisons and means that any preoperative-to-postoperative change, if reported elsewhere, would not be equivalent to a randomized treatment comparison. Masking is listed as NONE. The record does not explain whether outcome assessors were masked or how the measurements were conducted.

The registry gives enrollment of 9 but does not report how many participants completed follow-up or contributed to each outcome. The analyzed denominators, withdrawals, missing measurements, and analysis populations are not reported in the registry record. The primary outcome is stated in eyes, but the record does not explain how eye-level observations were handled in relation to participants.

The registry lists 8 outcome measures and 0 analyses, without a reported statistical analysis plan, multiplicity approach, confidence intervals, or inferential results. The safety information is limited to event counts; event descriptions and attribution are not reported. Finally, the planning illustration assumptions do not describe the actual single-group study design, and no sample-size justification for this study is reported in the registry record. These limitations concern what can be concluded from the registry information, not necessarily all information that may exist outside it.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Early Feasibility Study Using IOPCL MAG to Improve Near Vision in ARMD Subjects — NCT04984590.
• Registry record last updated 2025-01-31; status last verified 2025-01.
• Results first posted 2024-11-19.
• 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.

18. Record Summary

NCT04984590 is a completed early feasibility study of the IOPCL AMD MAG for secondary implantation after cataract surgery in people with age-related macular degeneration. The registry records enrollment of 9 and describes a single-group design, allocation listed as NA, no masking, and 12-month follow-up. All subjects were to receive a 10.0 Diopter device.

The primary endpoint is postoperative tilt of the PCIOL and IOPCL MAG complex at 12 Months, defined using a threshold of less than or equal to 10 degrees and measured in eyes. The registry lists 8 outcome measures and 0 analyses. It does not report the primary endpoint result or the listed visual-acuity results.

Safety figures record 0 serious adverse events among 9 at risk, 1 other adverse event among 9 at risk, and 0 deaths. Event descriptions and comparative safety results are not reported. The available record therefore describes the study design and intended outcomes, but does not provide outcome estimates or analysis details needed to assess the study’s visual or positional findings.