Trial · NCT01497067
Long Term Safety Protocol for the AcrySof CACHET Phakic Lens
NCT01497067, Not applicable, Completed, Alcon Research; results first posted 2019-06-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long Term Safety Protocol for the AcrySof CACHET Phakic Lens. Trials, record NCT01497067. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01497067
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long Term Safety Protocol for the AcrySof CACHET Phakic Lens
- NCT number
- NCT01497067
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 657 participants, actual
- Lead sponsor
- Alcon Research
- Conditions
- Myopia
- Interventions
- ACRYSOF CACHET Phakic Lens (L-series)
- First posted
- 2011-12-22
- Last updated
- 2019-07-02
- Results first posted
- 2019-06-26
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Central Endothelial Cell Density (All Eyes) | Year 4 to Year 10 postoperative from previous study (C-02-23, C-02-40, C-03-21, and C-05-57) | A microscope was used to photograph corneal endothelial cells (cells on the back of the cornea). Three images at the center of the cornea were obtained and sent to a central reading center for analysis. All recorded data from images were used in the analysis. A higher value for density represents a healthier cornea. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Central Endothelial Cell Density (All Eyes) | Year 4 to Year 10 postoperative from previous study (C-02-23, C-02-40, C-03-21, and C-05-57) | All subjects enrolled in the study (Safety Analysis). Some subjects were implanted in both eyes and therefore 2 eyes were enrolled. | cells/mm^2 | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Central Endothelial Cell Density (All Eyes) | CACHET | Year 4 | 2654.0 | Standard Deviation 354.6 | cells/mm^2 |
| Central Endothelial Cell Density (All Eyes) | CACHET | Year 5 | 2639.0 | Standard Deviation 324.2 | cells/mm^2 |
| Central Endothelial Cell Density (All Eyes) | CACHET | Year 5.5 | 2633.0 | Standard Deviation 357.6 | cells/mm^2 |
| Central Endothelial Cell Density (All Eyes) | CACHET | Year 6 | 2551.0 | Standard Deviation 362.3 | cells/mm^2 |
| Central Endothelial Cell Density (All Eyes) | CACHET | Year 6.5 | 2524.7 | Standard Deviation 360.6 | cells/mm^2 |
| Central Endothelial Cell Density (All Eyes) | CACHET | Year 7 | 2504.9 | Standard Deviation 365.8 | cells/mm^2 |
| Central Endothelial Cell Density (All Eyes) | CACHET | Year 7.5 | 2497.1 | Standard Deviation 364.7 | cells/mm^2 |
| Central Endothelial Cell Density (All Eyes) | CACHET | Year 8 | 2465.0 | Standard Deviation 384.2 | cells/mm^2 |
| Central Endothelial Cell Density (All Eyes) | CACHET | Year 8.5 | 2457.7 | Standard Deviation 363.0 | cells/mm^2 |
| Central Endothelial Cell Density (All Eyes) | CACHET | Year 9 | 2409.6 | Standard Deviation 388.4 | cells/mm^2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CACHET | 657 | |
| Overall Study | COMPLETED | CACHET | 575 | |
| Overall Study | NOT COMPLETED | CACHET | 82 |
Source ClinicalTrials.gov
Adverse events150
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Coronary artery occlusion | Cardiac disorders | CACHET - Ocular | 0 | 1,123 | |
| serious | Coronary artery occlusion | Cardiac disorders | CACHET - Systemic | 1 | 657 | |
| serious | Myocardial infarction | Cardiac disorders | CACHET - Ocular | 0 | 1,123 | |
| serious | Myocardial infarction | Cardiac disorders | CACHET - Systemic | 1 | 657 | |
| serious | Vertigo | Ear and labyrinth disorders | CACHET - Ocular | 0 | 1,123 | |
| serious | Vertigo | Ear and labyrinth disorders | CACHET - Systemic | 1 | 657 | |
| serious | Angle closure glaucoma | Eye disorders | CACHET - Ocular | 3 | 1,123 | |
| serious | Angle closure glaucoma | Eye disorders | CACHET - Systemic | 0 | 657 | |
| serious | Cataract | Eye disorders | CACHET - Ocular | 20 | 1,123 | |
| serious | Cataract | Eye disorders | CACHET - Systemic | 0 | 657 |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CACHET - Ocular | 0 | 1,123 |
| Total, all-cause mortality | CACHET - Systemic | 3 | 657 |
| Total, other adverse events | CACHET - Ocular | 0 | 1,123 |
| Total, other adverse events | CACHET - Systemic | 0 | 657 |
| Total, serious adverse events | CACHET - Ocular | 276 | 1,123 |
| Total, serious adverse events | CACHET - Systemic | 24 | 657 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CACHET - Ocular vs CACHET - Systemic: deaths from any cause | Trial comparisons |
| CACHET - Ocular vs CACHET - Systemic: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01497067
GET https://conductscience.org/api/trials/v1/NCT01497067/events?page=2