Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UMIN000017727 | Other Identifier | UMIN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the long-term visual acuity (VA) with an acrylic IOL to a silicone or polymethylmethacrylate (PMMA) IOL in cataract patients. This study will take place in Japan.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AcrySof IOL | Experimental | Acrylic IOL, prior implantation (1994-2000) in one or both eyes |
|
| Silicone IOL | Active Comparator | Silicone IOL, prior implantation (1994-2000) in one or both eyes |
|
| PMMA IOL | Active Comparator | PMMA IOL, prior implantation (1994-2000) in one or both eyes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acrylic IOL | Device | Acrylic IOL for long-term implantation in the cataract patient |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit | Measurement of best corrected (with spectacles or other visual corrective devices) visual acuity (at both near and distance). Visual Acuity (VA) is measured in logMAR (logarithm of the minimum angle of resolution). A lower logMAR value indicates better visual acuity. One eye (study eye) contributed to the analysis. | Baseline (up to and including 3 months after implantation), long-term post-implantation visit (14-20 years after implantation) |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Group Manager, Clinical Dev. | Alcon Japan, Ltd. | Study Director |
Not provided
Of the 104 enrolled, 6 subjects were exited as screen failures and deemed ineligible for participation. This reporting group includes all eligible subjects (98).
Subjects were recruited from 11 study centers located in Japan.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AcrySof | Acrylic IOL, prior implantation (1994-2000) in one or both eyes |
| FG001 | Silicone | Silicone IOL, prior implantation (1994-2000) in one or both eyes |
| FG002 | PMMA | Polymethylmethacrylate (PMMA) IOL, prior implantation (1994-2000) in one or both eyes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This analysis population includes all subjects who used the study devices and underwent the long-term post-implantation visit examination (Safety Set).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AcrySof | Acrylic IOL, prior implantation (1994-2000) in one or both eyes |
| BG001 | Silicone | Silicone IOL, prior implantation (1994-2000) in one or both eyes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit | Measurement of best corrected (with spectacles or other visual corrective devices) visual acuity (at both near and distance). Visual Acuity (VA) is measured in logMAR (logarithm of the minimum angle of resolution). A lower logMAR value indicates better visual acuity. One eye (study eye) contributed to the analysis. | This analysis population includes all subjects who used the study devices and have data after implantation of study devices (Full Analysis Set). | Posted | Mean | Standard Deviation | logMAR | Baseline (up to and including 3 months after implantation), long-term post-implantation visit (14-20 years after implantation) |
|
Adverse events (AEs) were collected for the duration of a subject's participation in the study; retrospectively 14 to 20 years and prospectively for a single visit. This analysis group includes all subjects who used the study devices and underwent the long-term post-implantation visit examination. Ocular adverse events are presented for both study eye and non-study eye combined.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, whether or not related to the investigational medical device (test/control article or procedure). AEs are reported retrospectively (onset between Baseline (defined as the period within 3 months after surgery) and Informed Consent acquisition) and prospectively (onset after Informed Consent acquisition).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AcrySof (Retrospective) | Subjects with prior implantation of acrylic IOL who experienced an AE related to decrease of BCVA in the study eye |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| posterior capsule opacification | Eye disorders | MedDRA/J (19.0) |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Phase IV, Clinical and Regulatory Affairs, Alcon Japan | Alcon, A Novartis Division | 1-888-451-3937 | alcon.medinfo@alcon.com |
| ID | Term |
|---|---|
| D019591 | Pseudophakia |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Silicone IOL | Device | Silicone IOL for long-term implantation in the cataract patient |
|
| PMMA IOL | Device | Polymethylmethacrylate IOL for long-term implantation in the cataract patient |
|
| BG002 | PMMA | Polymethylmethacrylate IOL, prior implantation (1994-2000) in one or both eyes |
| BG003 | Total | Total of all reporting groups |
| subjects |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Silicone | Silicone IOL, prior implantation (1994-2000) in one or both eyes |
| OG002 | PMMA | Polymethylmethacrylate IOL, prior implantation (1994-2000) in one or both eyes |
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Silicone (Retrospective) | Subjects with prior implantation of Silicone IOL who experienced an AE related to decrease of BCVA in the study eye | 0 | 37 | 3 | 37 |
| EG002 | PMMA (Retrospective) | Subjects with prior implantation of PMMA IOL who experienced an AE related to decrease of BCVA in the study eye | 0 | 30 | 4 | 30 |
| EG003 | AcrySof (Prospective) | Subjects with prior implantation of acrylic IOL who experienced an AE with onset after the Informed Consent acquisition | 0 | 31 | 0 | 31 |
| EG004 | Silicone (Prospective) | Subjects with prior implantation of Silicone IOL who experienced an AE with onset after the Informed Consent acquisition | 0 | 37 | 0 | 37 |
| EG005 | PMMA (Prospective) | Subjects with prior implantation of PMMA IOL who experienced an AE with onset after the Informed Consent acquisition | 0 | 30 | 0 | 30 |
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.