Efficacy of Acupuncture in Macular Diseases: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Efficacy of Acupuncture in Macular Diseases (NCT02255981), a na na study. The primary outcome is Eyes With Change From Baseline to the End of the Study in Distance Vision According to Categories CIE 10 Based on Lines Seen on the Snellen Chart..

2. Clinical Question

The clinical question is therefore descriptive: what visual-acuity changes were recorded during follow-up among participants receiving acupuncture and massage? Without a concurrent control group, the study cannot isolate the effect of treatment from the natural course of disease, measurement variation, or other influences. The registry summary itself notes the absence of a placebo group and proposes external comparisons as context, but no such results are reported in the registry record. The listed secondary outcomes concern changes in vision, including less opacity, less distortion of lines, or reduction of a central shadow, and adverse events. Their results are not reported in the registry record. This means the clinical question can be stated from the protocol description, but the posted record does not provide enough outcome information to judge the observed visual changes or compare them with an alternative approach.

3. Trial Design

This was a completed, single-group study with an enrollment of 33 participants. The registry lists allocation as NA, masking as none, and the model as single group. All participants received acupuncture and massage; there was no placebo group. The registry summary explains that the study did not use a placebo because the investigators considered this unsuitable for evaluating a procedure in Chinese Medicine. That rationale does not create a controlled comparison: treatment assignment was not compared with a concurrent untreated or differently treated group.

The listed conditions were age-related macular degeneration, Stargardt disease, and macular dystrophy. The intervention was acupuncture and massage, described as Traditional Chinese Medicine. The arm description specifies treatment for 24 months. The record states that ophthalmological review took place every two months, using both eyes and best correction for visual-acuity assessments. The registry lists the phase as NA; a phase designation is not applicable or otherwise specified in the record.

The primary outcome concerns eyes with change from baseline to the end of the study in distance vision, classified according to CIE 10 categories based on lines seen on the Snellen chart. The timeframe is 24 months from baseline. The record lists six outcome measures and one analysis, but does not report a detailed statistical analysis plan or outcome results. It also does not report how participants with more than one listed macular condition were distributed or analyzed, or provide detailed eligibility criteria, treatment adherence, or follow-up completion.

The registry status is completed, with a start date of 2013-03 and primary completion date of 2016-05. Completion status indicates the study is recorded as completed; it does not establish that every participant completed follow-up or that results were reported. Any comparison to external literature or expected disease progression would be nonconcurrent and is not presented 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: 35 patients were eligible, 2 refused to participate, 29 completed follow up. There was not an assignment, all received the same treatment although the diagnostics comprised different forms of macular damage it was pre-specified to analyze them as a single group for the Outcomes 2 eyes were excluded: 1 blind and 1 with retinal detachment.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: The primary analysis includes only patients who completed the 24-month exam. The improvement in this outcome is measured on eyes which had a vision gain in lines of the Snellen chart.

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: 35 patients met inclusion criteria, 33 consented to participate, 4 dropped off, 29 ended the 24 month period of treatment and observation

6. Primary Endpoint

The registry lists the primary outcome as Eyes With Change From Baseline to the End of the Study in Distance Vision According to Categories CIE 10 Based on Lines Seen on the Snellen Chart., measured over 24 months from baseline..

The primary endpoint counts eyes with a change in distance visual acuity from baseline to the end of the study. Visual acuity was assessed using the number of lines correctly seen on a Snellen chart, with measurements made by ophthalmologic assessment at the start of the study and every two months through month 24. The description says testing used best correction, a sitting position, and a testing distance of 6 meters. Change was understood as lines gained or lost by each eye, and the endpoint is framed in categories based on CIE 10.

This type of endpoint is intended to express whether measured vision improved, stayed stable, or worsened over follow-up, rather than relying solely on a single measurement at one time. Counting eyes makes the eye the unit of the stated primary outcome, while the enrolled population is described in participants. Those are not interchangeable units: some participants contribute measurements from both eyes, and the registry does not report how many eyes were included in the primary analysis or how dependence between two eyes from one participant was handled.

The endpoint description includes reference thresholds for levels of visual acuity, including mild, moderate, severe, and blindness. These thresholds help describe the clinical context of the Snellen measurements, but the record does not give the observed number of eyes in any change category. It also does not provide a complete operational definition for every category: the description of stable vision ends mid-sentence. Most importantly, the posted record does not report the primary endpoint results, so the outcome definition alone cannot establish the direction, frequency, or magnitude of visual change.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

Statistical interpretation starts with identifying the question, the unit of observation, and the comparison the design can support. Here, the primary question concerns change in visual acuity over follow-up among participants receiving acupuncture and massage. The stated unit of the primary outcome is eyes. The design is single group, so the available conceptual comparison is each eye's measurement at baseline versus its later measurement. That is not the same as comparing treatment with an untreated or alternative-treatment group.

What does a baseline-to-follow-up comparison show?

In general, a before-and-after comparison describes how measurements changed over time in the observed group. It can characterize the course of measurements during the study, but it cannot alone show why they changed. A treatment effect is a contrast between outcomes under different treatment conditions. When everyone receives the same intervention, the registry does not contain a concurrent treatment contrast. Possible influences on change include the natural course of disease, measurement variability, changes in other care, and factors that differ over time. These are general design considerations, not claims that any particular influence occurred in this study.

The summary states that the outcomes could be contrasted with medical publications and expectations about progression without treatment. In general, such external comparisons require caution because populations, outcome definitions, assessment schedules, and other study features may differ. A concurrent control group helps make groups more comparable by observing them over the same period under different assigned conditions. This record describes no placebo group or other concurrent comparison, and does not report an external comparison analysis.

Why does the eye-level outcome matter?

The endpoint is stated as a count of eyes, but participants are the enrolled units. If both eyes of a participant are measured, those observations are not necessarily independent: they share characteristics and experiences. In general, methods for paired or clustered data account for this relationship. Ignoring within-person dependence can misstate the uncertainty around an estimate. The registry record does not report the number of eyes analyzed, whether both eyes contributed for every participant, or the method used to account for dependence. As a result, an independent assessment of the eye-level analysis is not possible from the record.

The Snellen assessment is described in terms of lines correctly identified, with visual-acuity change expressed as lines gained or lost. The endpoint also refers to CIE 10 categories. Categorizing a continuous or ordered measurement can make results easier to describe in clinical terms, but categories can conceal variation within each category and depend on clear definitions. The registry's description of the stable category is incomplete, and no category counts are reported. The assessment schedule is described, but the record does not report whether measurements were available at every scheduled visit for every participant.

How should estimates and uncertainty be read?

In general, an effect estimate summarizes the observed difference or change using a defined scale. A confidence interval communicates uncertainty around an estimate under the assumptions of the statistical method. Narrower intervals indicate greater precision than wider intervals, but precision does not by itself resolve design limitations such as absence of a control group. Neither an effect estimate nor a confidence interval for the primary outcome is reported in the registry record. A p-value is also not reported. General statistical interpretation treats a p-value as a measure of how compatible observed data are with a specified null model, not as the probability that a treatment is effective or as a measure of clinical importance.

Counts and percentages are often used for categorical outcomes. In general, a count gives the number of observations in a category, while a percentage places that count in relation to a defined denominator. The endpoint is a count of eyes, so interpretation would require knowing both category counts and the number of eyes contributing data. The registry record does not report those results or the analysis denominator. The participant enrollment figure should not be substituted for an unreported eye-level denominator.

What does over-dispersion mean in general?

For count outcomes, a statistical model may assume a particular relationship between the average count and its variability. Over-dispersion means the observed variability is greater than that assumed by a simpler model. If it is ignored, uncertainty can be underestimated and statistical tests may be too optimistic. This is a general consideration for count data, not a statement that over-dispersion was present or that a particular count model was used in this study. The registry record does not report a model specification, a dispersion estimate, or enough primary outcome data to assess this issue.

What are planning illustrations?

Sample-size calculations are prospective planning exercises. They ask how much information might be needed to detect a chosen effect under stated assumptions. The registry describes planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation; the stated effect is a fraction of the observed effect. Such illustrations are hypothetical and do not show that this single-group trial had the corresponding design, allocation, or comparison. They are not observed power. The registry record does not report the trial's own sample-size justification, and the planning assumptions should not be treated as its protocol.

For time-to-event outcomes, a planning calculation may concern the total number of events; for other outcomes, the stated convention is participants per arm. That distinction is general to the planning description and does not turn the study into a two-arm trial. The reported design remains single group. More broadly, statistical methods can clarify uncertainty only when the outcome data, analysis population, and model are sufficiently described. Those details are not reported for the primary result in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists six outcome measures and one analysis. Multiple outcomes create a multiplicity issue: when several results are examined, the chance of at least one apparently unusual finding can increase, depending on the analyses and decision rules used. In general, investigators may define one primary outcome in advance, adjust for multiple comparisons, or interpret secondary outcomes as exploratory. The registry identifies a primary outcome and lists secondary outcomes, but whether any multiplicity strategy was planned or applied is not reported in the registry record.

The record does not report the primary outcome results, the secondary outcome results, or detailed analysis methods. It therefore does not establish which outcomes contributed to the reported analysis, how comparisons across time were handled, or whether any adjustment was made. The fact that one analysis is listed does not by itself explain the analytical model, define every analysis population, or show how repeated measurements were incorporated.

Missing-data handling is also not reported in the registry record. The assessment plan describes repeated ophthalmological reviews through 24 months, but it does not provide the number of participants or eyes with measurements at each visit, the number completing the planned follow-up, or how absent measurements were treated. In general, missing outcomes can affect estimates when the likelihood of missingness is related to health status or observed outcomes. The direction and extent of any such effect cannot be assessed without information about missingness and the analysis approach.

The analysis population is not reported in the registry record. It is therefore unclear whether the primary analysis included all enrolled participants, only those with follow-up measurements, or another defined group. The distinction matters because exclusions after enrollment can change the population represented by an estimate. No assumptions about imputation, participant withdrawal, or exclusion criteria should be inferred from the outcome schedule alone.

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.

The registry reports zero serious adverse events, zero other adverse events, and zero deaths among 33 participants at risk. These figures describe the recorded counts for the study group. They do not compare event rates with another treatment or with no treatment, because the study had no concurrent control group.

The listed secondary outcome includes participants with adverse events whether treatment-related or not related to treatment. The registry's safety listing separates serious events from other events, but it does not provide event terms or further detail about how events were identified, classified, or followed. It also does not report the completeness of safety follow-up or explain whether all participants contributed the same amount of observation time. The counts should therefore be read as registry-reported events, not as a complete characterization of every possible safety outcome.

A report of zero events in a group does not establish that the true risk is zero. In general, uncommon events may not appear in a study of limited size, and the ability to detect safety patterns also depends on follow-up and event ascertainment. No comparative safety estimate or precision interval is reported in the registry record. The figures are useful as a description of what was recorded, but they do not by themselves establish that the intervention caused no harm or that its safety differs from another approach.

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

The record documents a completed single-group study of acupuncture and massage for participants with several chronic macular diseases. It describes an ophthalmological visual-acuity assessment using the Snellen chart over 24 months and lists adverse-event outcomes. It reports enrollment of 33 participants and safety counts of zero serious adverse events, zero other adverse events, and zero deaths. These are the specific findings that can be stated from the posted record.

The record does not report the primary outcome counts for eyes that improved, remained stable, or worsened. It also does not report numerical findings for the listed secondary outcomes, an effect estimate, a confidence interval, or a p-value. The absence of these results means the direction and precision of visual change cannot be assessed from the registry record. It should not be interpreted as evidence that no visual change occurred.

Even if before-and-after outcome results were available, the single-group design would limit causal interpretation. Change over time among treated participants is not equivalent to a difference between treated and untreated participants. Without a concurrent control group, it is difficult to separate any intervention-related change from the natural course of disease or other influences. The proposed comparison with published reports or expected untreated progression is not reported as an analysis and would not automatically provide the same strength of comparison as a concurrent control.

These limitations do not make the study description meaningless. The measurement plan and reported safety counts help define what was intended to be observed and what the registry records. However, an assessment of efficacy would require outcome results, defined denominators, and sufficient analytical detail, while a comparative treatment claim would require an appropriate comparison and careful consideration of bias. The registry record does not provide those elements. Accordingly, no conclusion about whether acupuncture and massage changed visual acuity, or how any change compares with another approach, can be drawn from the posted results.

13. Why This Trial Matters Statistically

This study is statistically informative because it illustrates the difference between measuring change and estimating a treatment effect. Repeated visual-acuity assessments can describe how participants' measurements vary over time. But when all participants receive the same intervention, there is no concurrent contrast to show what their outcomes might have been under a different treatment condition. The design therefore supports a narrower descriptive question than a controlled efficacy comparison.

The choice of unit also matters. The primary outcome is framed as a count of eyes, while enrollment is reported in participants. If participants contribute measurements from both eyes, observations may be correlated within a person. Statistical analysis and interpretation should make clear how the eye-level data were handled. Because that information and the analyzed eye count are not reported in the registry record, readers cannot assess the dependence structure or the precision of an eye-based result.

Outcome definitions and reporting are equally important. The record explains that visual acuity was measured by Snellen chart lines and categorized, but it does not provide the category counts or a complete definition of the stable category. Without actual results and denominators, readers cannot assess the distribution of changes, the amount of missing information, or the uncertainty around any estimate. A completed status does not replace reporting of those details.

The record also highlights the difference between a planning illustration and a trial's actual design. A calculation based on an observed effect and assumptions about two-arm allocation is hypothetical; it is not evidence that the study used such an allocation, and it is not observed power. The study is recorded as single group. Keeping planning assumptions separate from the conducted design prevents readers from mistaking a hypothetical calculation for evidence about the study's ability to detect an effect.

Finally, safety counts need context. Zero recorded events is a descriptive result for the participants at risk, not proof of zero risk and not a comparative safety conclusion. Clear denominators, ascertainment methods, follow-up completeness, and uncertainty are important for interpreting safety as well as efficacy. The registry record provides some of the design and measurement context, but leaves key outcome and analysis details unreported.

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.

Several limitations follow directly from the registry description. The study is single group, with no placebo or other concurrent comparator and no masking. Before-and-after measurements can describe change but cannot separate the intervention from the natural course of disease, measurement variability, or other influences over time. Although the summary mentions possible comparisons with published medical reports and expected progression without treatment, results from those comparisons are not reported in the registry record.

The population includes age-related macular degeneration, Stargardt disease, and macular dystrophy. The record does not report condition-specific outcome results or explain whether outcomes were analyzed separately by diagnosis. As a result, the posted information cannot show whether patterns differed among the listed conditions. The enrollment figure is for participants, while the primary endpoint counts eyes; the number of analyzed eyes and the handling of paired eyes are not reported.

The primary endpoint description is incomplete. It explains the Snellen-based measurement and refers to CIE 10 categories, but the description of the stable category ends before the definition is complete. The record does not report primary outcome counts, effect estimates, uncertainty measures, or detailed statistical methods. It also does not report the analysis population, follow-up completion, missing-data handling, or a sample-size justification.

Six outcome measures are listed, but the registry does not report whether a multiplicity strategy was used or provide results for the secondary outcomes. The safety listing gives event counts but not event terms, ascertainment detail, or the completeness of follow-up. These gaps limit evaluation of both benefit-related outcomes and safety. The completed status and stated treatment duration do not resolve these reporting limitations.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Efficacy of Acupuncture in Macular Diseases — NCT02255981.
• Registry record last updated 2020-06-16; status last verified 2020-06.
• Results first posted 2020-04-01.
• 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.

18. Record Summary

The registry describes a completed single-group study of acupuncture and massage for chronic macular diseases, with 33 participants enrolled. The listed conditions are age-related macular degeneration, Stargardt disease, and macular dystrophy. The intervention is described as Traditional Chinese Medicine acupuncture and massage over 24 months, with ophthalmological review every two months.

The primary outcome is a count of eyes with change in distance vision from baseline to the end of the study, based on Snellen chart lines and CIE 10 categories. The registry record does not report the primary outcome results, secondary outcome results, effect estimates, confidence intervals, p-values, or detailed analysis methods. It lists six outcome measures and one analysis.

There was no placebo or other concurrent control group, and masking is listed as none. The safety record reports zero serious adverse events, zero other adverse events, and zero deaths among 33 participants at risk. These counts are descriptive and do not provide a comparative safety estimate. The registry lists study dates of 2013-03 to 2016-05 for start and primary completion, and the status is completed.