Pseudophakia
Conditions
Brief summary
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.
Interventions
DEVICEAcrylic IOL
Acrylic IOL for long-term implantation in the cataract patient
DEVICESilicone IOL
Silicone IOL for long-term implantation in the cataract patient
DEVICEPMMA IOL
Polymethylmethacrylate IOL for long-term implantation in the cataract patient
Sponsors
Alcon, a Novartis Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Willing to provide voluntary consent and able to comprehend and sign the informed consent form; * Pseudophakic patients implanted with an Acrylic (AcrySof®), PMMA or silicone IOL from 1994 to 2000; * Clear intraocular media in study eye; * Best-corrected visual acuity (decimal) within 3 months post-implantation of 0.8 (decimal VA chart) or more in study eye; * No ocular or systemic condition which may affect visual acuity in study eye; * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Complications that may impact visual acuity in study eye at the time of the prospective visit, such as glaucoma, diabetic retinitis, ocular inflammatory disease, retinal detachment, and others as specified in the protocol; * Previous refractive surgery in study eye; * Previous IOL exchange in study eye; * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit | Baseline (up to and including 3 months after implantation), long-term post-implantation visit (14-20 years after implantation) | 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. |
Participant flow
Recruitment details
Subjects were recruited from 11 study centers located in Japan.
Pre-assignment details
Of the 104 enrolled, 6 subjects were exited as screen failures and deemed ineligible for participation. This reporting group includes all eligible subjects (98).
Participants by arm
| Arm | Count |
|---|---|
| AcrySof Acrylic IOL, prior implantation (1994-2000) in one or both eyes | 31 |
| Silicone Silicone IOL, prior implantation (1994-2000) in one or both eyes | 37 |
| PMMA Polymethylmethacrylate IOL, prior implantation (1994-2000) in one or both eyes | 30 |
| Total | 98 |
Baseline characteristics
| Characteristic | Total | AcrySof | Silicone | PMMA |
|---|---|---|---|---|
| Age, Customized ≥70 and ≤79 years | 45 subjects | 13 subjects | 21 subjects | 11 subjects |
| Age, Customized <70 years | 12 subjects | 2 subjects | 4 subjects | 6 subjects |
| Age, Customized ≥80 and ≤89 years | 33 subjects | 12 subjects | 12 subjects | 9 subjects |
| Age, Customized >90 years | 8 subjects | 4 subjects | 0 subjects | 4 subjects |
| Sex: Female, Male Female | 66 Participants | 23 Participants | 24 Participants | 19 Participants |
| Sex: Female, Male Male | 32 Participants | 8 Participants | 13 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 31 | 3 / 37 | 4 / 30 | 0 / 31 | 0 / 37 | 0 / 30 |
| serious Total, serious adverse events | 0 / 31 | 0 / 37 | 0 / 30 | 0 / 31 | 0 / 37 | 0 / 30 |
Outcome results
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.
Time frame: Baseline (up to and including 3 months after implantation), long-term post-implantation visit (14-20 years after implantation)
Population: This analysis population includes all subjects who used the study devices and have data after implantation of study devices (Full Analysis Set).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AcrySof | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit | Baseline | -0.06 logMAR | Standard Deviation 0.07 |
| AcrySof | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit | Change from baseline | 0.01 logMAR | Standard Deviation 0.08 |
| Silicone | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit | Baseline | -0.09 logMAR | Standard Deviation 0.07 |
| Silicone | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit | Change from baseline | 0.04 logMAR | Standard Deviation 0.06 |
| PMMA | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit | Baseline | -0.07 logMAR | Standard Deviation 0.08 |
| PMMA | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit | Change from baseline | -0.01 logMAR | Standard Deviation 0.05 |