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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CACHET | Experimental | ACRYSOF CACHET Phakic Lens (L-series) previously implanted |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACRYSOF CACHET Phakic Lens (L-series) | Device | Intraocular lens for the treatment of moderate to high myopia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Year 4 to Year 10 postoperative from previous study (C-02-23, C-02-40, C-03-21, and C-05-57) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sr. Project Lead, Surgical | Alcon Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
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This reporting group includes all enrolled subjects.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | CACHET | ACRYSOF CACHET Phakic Lens (L-series) previously implanted |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CACHET | ACRYSOF CACHET Phakic Lens (L-series) previously implanted |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All subjects enrolled in the study (Safety Analysis). Some subjects were implanted in both eyes and therefore 2 eyes were enrolled. | Posted | Mean | Standard Deviation | cells/mm^2 | Year 4 to Year 10 postoperative from previous study (C-02-23, C-02-40, C-03-21, and C-05-57) | eyes | eyes |
|
Adverse events were collected from time of enrollment until study exit for an individual duration up to 6 years based on time of enrollment.
Adverse Events (AE) were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. This analysis population includes all subjects enrolled in the study. Number at risk for ocular adverse events is presented with unit eyes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CACHET - Ocular | All eyes previously implanted with ACRYSOF CACHET Phakic Lens (L-series) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Coronary artery occlusion | Cardiac disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Clinical Trial Lead, Surgical | Alcon Research | 1-888-451-3937 | alcon.medinfo@alcon.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 5, 2018 | May 8, 2019 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 18, 2013 | May 8, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Other |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| eyes |
|
|
| 0 |
| 1,123 |
| 276 |
| 1,123 |
| 0 |
| 1,123 |
| EG001 | CACHET - Systemic | All subjects previously implanted with ACRYSOF CACHET Phakic Lens (L-series) | 3 | 657 | 24 | 657 | 0 | 657 |
| Myocardial infarction | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Angle closure glaucoma | Eye disorders | MedDRA | Systematic Assessment |
|
| Cataract | Eye disorders | MedDRA | Systematic Assessment |
|
| Cataract cortical | Eye disorders | MedDRA | Systematic Assessment |
|
| Cataract nuclear | Eye disorders | MedDRA | Systematic Assessment |
|
| Cataract subcapsular | Eye disorders | MedDRA | Systematic Assessment |
|
| Choroidal neovascularisation | Eye disorders | MedDRA | Systematic Assessment |
|
| Corneal endothelial cell loss | Eye disorders | MedDRA | Systematic Assessment |
|
| Corneal oedema | Eye disorders | MedDRA | Systematic Assessment |
|
| Exophthalmos | Eye disorders | MedDRA | Systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA | Systematic Assessment |
|
| Iris adhesions | Eye disorders | MedDRA | Systematic Assessment |
|
| Iris atrophy | Eye disorders | MedDRA | Systematic Assessment |
|
| Iris disorder | Eye disorders | MedDRA | Systematic Assessment |
|
| Lens discolouration | Eye disorders | MedDRA | Systematic Assessment |
|
| Lens dislocation | Eye disorders | MedDRA | Systematic Assessment |
|
| Lenticular opacities | Eye disorders | MedDRA | Systematic Assessment |
|
| Macular oedema | Eye disorders | MedDRA | Systematic Assessment |
|
| Ocular hypertension | Eye disorders | MedDRA | Systematic Assessment |
|
| Open angle glaucoma | Eye disorders | MedDRA | Systematic Assessment |
|
| Pupillary deformity | Eye disorders | MedDRA | Systematic Assessment |
|
| Retinal degeneration | Eye disorders | MedDRA | Systematic Assessment |
|
| Retinal detachment | Eye disorders | MedDRA | Systematic Assessment |
|
| Retinal tear | Eye disorders | MedDRA | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA | Systematic Assessment |
|
| Accidental death | General disorders | MedDRA | Systematic Assessment |
|
| Device dislocation | General disorders | MedDRA | Systematic Assessment |
|
| Eye complication associated with device | General disorders | MedDRA | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Dislocation of vertebra | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA | Systematic Assessment |
|
| Visual acuity tests abnormal | Investigations | MedDRA | Systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Spinal deformity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Meningioma benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Pituitary tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Throat cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Intracranial aneurysm | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Myelopathy | Nervous system disorders | MedDRA | Systematic Assessment |
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| Radiculopathy | Nervous system disorders | MedDRA | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
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| Visual field defect | Nervous system disorders | MedDRA | Systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Cataract operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Corneal operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Eye operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Glaucoma surgery | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Hysterectomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Intra-ocular injection | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Intraocular lens extraction | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Intraocular lens implant | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Intraocular lens repositioning | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Iridotomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Iris operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Keratomileusis | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Knee operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Lens extraction | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Retinal laser coagulation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Retinal operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
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| Retinopexy | Surgical and medical procedures | MedDRA | Systematic Assessment |
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| Scleral buckling surgery | Surgical and medical procedures | MedDRA | Systematic Assessment |
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| Trabeculectomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Trabeculoplasty | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Vitrectomy | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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Sponsor reserves the right of prior review of any publication or presentation of information related to the study.