Myopia
Conditions
Keywords
Phakic Lens, Intraocular Lens (IOL)
Brief summary
The purpose of this long term safety study is to estimate the annualized endothelial cell loss (ECL) rate (for up to 10 years following date of implantation) of subjects previously implanted with the ACRYSOF CACHET Phakic Intraocular Lens (L-series) from precursor clinical studies C-02-23, C-02-40, C-03-21 and C-05-57.
Detailed description
Subjects previously enrolled in protocols C-02-23 (NCT00726024), C-02-40 (NCT00727805), C-03-21 (NCT00726297), and C-05-57 (NCT00727688) who received an L-series lens either in the first eye or second eye (including those who were explanted) were enrolled in this open-label, non-randomized, non-controlled, extension study in which they attended postoperative visits for up to 10 years following the date of implantation. Subjects could enroll in the study at any time, thus the Entrance Visit may have coincided with any visit (Year 4 to Year 10).
Interventions
DEVICEACRYSOF CACHET Phakic Lens (L-series)
Intraocular lens for the treatment of moderate to high myopia
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Previously implanted with an ACRYSOF CACHET Phakic Lens (L-Series) from clinical studies C-02-23, C-02-40, C-03-21 and C-05-57 and eligible for continued follow-up (i.e., exited from the previous study). * Able to understand and sign a statement of informed consent. * Willing and able to complete the yearly postoperative study visits.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
This study enrolled subjects at 20 investigative sites located in the US, 9 investigative sites located in the European Union, and 5 investigative sites located in Canada.
Pre-assignment details
This reporting group includes all enrolled subjects.
Participants by arm
| Arm | Count |
|---|---|
| CACHET ACRYSOF CACHET Phakic Lens (L-series) previously implanted | 657 |
| Total | 657 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Lost to Follow-up | 56 |
| Overall Study | Other | 13 |
| Overall Study | Patient decision unrel to Adverse Event | 10 |
Baseline characteristics
| Characteristic | CACHET |
|---|---|
| Age, Continuous | 37.5 years STANDARD_DEVIATION 7.9 |
| Race/Ethnicity, Customized Asian | 34 Participants |
| Race/Ethnicity, Customized Black or African American | 14 Participants |
| Race/Ethnicity, Customized Hispanic | 3 Participants |
| Race/Ethnicity, Customized Multi-racial | 1 Participants |
| Race/Ethnicity, Customized Other | 8 Participants |
| Race/Ethnicity, Customized White | 597 Participants |
| Sex: Female, Male Female | 448 Participants |
| Sex: Female, Male Male | 209 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,123 | 3 / 657 |
| other Total, other adverse events | 0 / 1,123 | 0 / 657 |
| serious Total, serious adverse events | 276 / 1,123 | 24 / 657 |
Outcome results
Primary
Central Endothelial Cell Density (All Eyes)
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.
Time frame: Year 4 to Year 10 postoperative from previous study (C-02-23, C-02-40, C-03-21, and C-05-57)
Population: All subjects enrolled in the study (Safety Analysis). Some subjects were implanted in both eyes and therefore 2 eyes were enrolled.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CACHET | Central Endothelial Cell Density (All Eyes) | Year 4 | 2654.0 cells/mm^2 | Standard Deviation 354.6 |
| CACHET | Central Endothelial Cell Density (All Eyes) | Year 5 | 2639.0 cells/mm^2 | Standard Deviation 324.2 |
| CACHET | Central Endothelial Cell Density (All Eyes) | Year 5.5 | 2633.0 cells/mm^2 | Standard Deviation 357.6 |
| CACHET | Central Endothelial Cell Density (All Eyes) | Year 6 | 2551.0 cells/mm^2 | Standard Deviation 362.3 |
| CACHET | Central Endothelial Cell Density (All Eyes) | Year 6.5 | 2524.7 cells/mm^2 | Standard Deviation 360.6 |
| CACHET | Central Endothelial Cell Density (All Eyes) | Year 7 | 2504.9 cells/mm^2 | Standard Deviation 365.8 |
| CACHET | Central Endothelial Cell Density (All Eyes) | Year 7.5 | 2497.1 cells/mm^2 | Standard Deviation 364.7 |
| CACHET | Central Endothelial Cell Density (All Eyes) | Year 8 | 2465.0 cells/mm^2 | Standard Deviation 384.2 |
| CACHET | Central Endothelial Cell Density (All Eyes) | Year 8.5 | 2457.7 cells/mm^2 | Standard Deviation 363 |
| CACHET | Central Endothelial Cell Density (All Eyes) | Year 9 | 2409.6 cells/mm^2 | Standard Deviation 388.4 |
| CACHET | Central Endothelial Cell Density (All Eyes) | Year 9.5 | 2399.3 cells/mm^2 | Standard Deviation 387.9 |
| CACHET | Central Endothelial Cell Density (All Eyes) | Year 10 | 2377.5 cells/mm^2 | Standard Deviation 398 |