Comparison · NCT01497067-sae
CACHET - Ocular vs CACHET - Systemic: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. CACHET - Ocular vs CACHET - Systemic: serious adverse events. Trial comparisons, record NCT01497067-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01497067-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.246 | 0.221 | 0.272 | wilson | |
| Risk in group 2 | 0.0365 | 0.0247 | 0.0538 | wilson | |
| Risk difference, group 1 minus group 2 | 0.209 | 0.179 | 0.238 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 6.73 | 4.48 | 10.1 | log | |
| Odds ratio, group 1 over group 2 | 8.59 | 5.59 | 13.2 | log | |
| Number needed to harm, for one more participant with a serious adverse event on CACHET - Ocular than on CACHET - Systemic | 4.78 | 4.2 | 5.57 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | CACHET - Ocular | All eyes previously implanted with ACRYSOF CACHET Phakic Lens (L-series) | 276 | 1,123 | EG000 |
| Group 2 | CACHET - Systemic | All subjects previously implanted with ACRYSOF CACHET Phakic Lens (L-series) | 24 | 657 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment.
Source ClinicalTrials.gov
Trial
- Title
- Long Term Safety Protocol for the AcrySof CACHET Phakic Lens
- NCT number
- NCT01497067
- Phases
- NA
- Conditions
- Myopia
- Interventions
- ACRYSOF CACHET Phakic Lens (L-series)
- Lead sponsor
- Alcon Research
- Results first posted
- 2019-06-26
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01497067?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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