Cataract
Conditions
Brief summary
The purpose of this study is to evaluate near vision of the One-Piece Tecnis Multifocal lens (ZMB00) vs. the One-piece Tecnis monofocal lens (ZCB00)and additionally evaluate general postoperative outcomes of the One-Piece Tecnis Multifocal lens.
Interventions
DEVICEOne-Piece Tecnis Multifocal IOL
One-piece Tecnis Multifocal IOL, Model ZMB00, implanted lens.
DEVICEOne-Piece Tecnis monofocal IOL, Model ZCB00
Control lens: One-Piece Tecnis monofocal IOL, Model, ZCB00, implanted lens.
Sponsors
Abbott Medical Optics
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* bilateral cataracts and otherwise healthy eyes * visual potential of Decimal 0.8 in each eye
Exclusion criteria
* any medications affecting vision * any chronic disease/illness that would affect risk to subject or outcomes of the study * any ocular pathology/abnormalities that may affect visual outcomes or confound study results * desire for monovision
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm | 4-6 Months | Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/24 for the Multifocal Group. Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/81 for the Monofocal Group. |
Secondary
| Measure | Time frame |
|---|---|
| Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity | 4-6 months |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ZMB00 Multifocal Intraocular Lens Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens | 34 |
| ZCB00 Monofocal Intraocular Lens Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens | 33 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Not implanted bilaterally | 2 | 1 |
Baseline characteristics
| Characteristic | ZMB00 Multifocal Intraocular Lens | ZCB00 Monofocal Intraocular Lens | Total |
|---|---|---|---|
| Age, Continuous | 63.1 years STANDARD_DEVIATION 11.4 | 68.3 years STANDARD_DEVIATION 11.3 | 65.9 years STANDARD_DEVIATION 11.6 |
| Sex: Female, Male Female | 23 Participants | 17 Participants | 40 Participants |
| Sex: Female, Male Male | 11 Participants | 16 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 36 | 4 / 34 |
| serious Total, serious adverse events | 0 / 36 | 0 / 34 |
Outcome results
Primary
Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm
Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/24 for the Multifocal Group. Snellen equivalent for the mean logMAR binocular photopic distance corrected near visual acuity at 33 cm is 20/81 for the Monofocal Group.
Time frame: 4-6 Months
Population: Within the 4-6 month time frame, one assessment was performed per participant. Though 70 subjects started the study (36 ZMB00; 34 ZCB00), data for logMAR binocular photopic distance corrected near visual acuity at 33 were available for only 33 ZMB00 and 31 ZCB00 subjects at the the 4-6 month visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ZMB00 Multifocal Intraocular Lens | Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm | 0.07 logMAR visual acuity | Standard Deviation 0.12 |
| ZCB00 Monofocal Intraocular Lens | Mean LogMAR Binocular Photopic Distance Corrected Near Visual Acuity at 33 cm | 0.61 logMAR visual acuity | Standard Deviation 0.15 |
Secondary
Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity
Time frame: 4-6 months
Population: Within the 4-6 month time frame, one assessment was performed per participant. Though 70 subjects started the study (36 ZMB00; 34 ZCB00), best corrected binocular diatance visual acuity data were available for only 32 ZMB00 and 31 ZCB00 subjects at the the 4-6 month visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ZMB00 Multifocal Intraocular Lens | Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity | 32 participants |
| ZCB00 Monofocal Intraocular Lens | Number of Subjects With 20/40 or Better Best Corrected Binocular Distance Visual Acuity | 31 participants |