Cataract
Conditions
Keywords
Cataract
Brief summary
The objective of this study is to evaluate safety and effectiveness of ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1 when implanted to replace the natural lens following cataract removal.
Interventions
DEVICEACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1
Implantation with the AcrySof ReSTOR Intraocular Lens (IOL) Model SN6AD1 following cataract removal.
Sponsors
Alcon Research
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Planned bilateral cataract removal by phacoemulsification * Potential postoperative best corrected visual acuity of 0.5 or over * 1.5 Diopter (D) or less of astigmatism preoperatively, measured by keratometry
Exclusion criteria
* Poorly controlled glaucoma * Progressive diabetic retinopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uncorrected Intermediate Visual Acuity | 1 year after surgery | Binocular Uncorrected Intermediate Visual Acuity, measured at 1 meter and 50 centimeters measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction. |
| Uncorrected Distance Visual Acuity | 1 year after surgery | Binocular Uncorrected Dinstance Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction. |
| Uncorrected Near Visual Acuity | 1 year after surgery | Binocular Near Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction. |
Countries
Japan
Participant flow
Recruitment details
Only adult subjects of either gender in need of cataract extraction in both eyes were considered for enrollment. 64 subjects were implanted bilaterally with the ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1
Pre-assignment details
Subjects were examined to ensure inclusion/exclusion criteria. Only subjects who signed an informed consent and qualified to be in the study were enrolled. Subject numbers were assigned after obtaining consent meeting inclusion/exclusion criteria. Subjects were considered enrolled once implanted in the first operative eye.
Participants by arm
| Arm | Count |
|---|---|
| SN6AD1 ACRYSOF® ReSTOR® Aspheric +3.0 D (Diopter) Add Power Intraocular Lens (IOL) Model SN6AD1 | 64 |
| Total | 64 |
Baseline characteristics
| Characteristic | SN6AD1 |
|---|---|
| Age, Customized 60 - 69 years of age | 23 Participants |
| Age, Customized <60 years of age | 6 Participants |
| Age, Customized 70 - 79 years of age | 33 Participants |
| Age, Customized >80 years of age | 2 Participants |
| Sex: Female, Male Female | 60 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 64 |
| serious Total, serious adverse events | 1 / 64 |
Outcome results
Primary
Uncorrected Distance Visual Acuity
Binocular Uncorrected Dinstance Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.
Time frame: 1 year after surgery
Population: One patient dropped out after the visit 6 months following surgery but before the 1 year visit.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SN6AD1 | Uncorrected Distance Visual Acuity | 1.122 Decimal Visual Acuity |
Primary
Uncorrected Intermediate Visual Acuity
Binocular Uncorrected Intermediate Visual Acuity, measured at 1 meter and 50 centimeters measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.
Time frame: 1 year after surgery
Population: One patient dropped out after the visit 6 months following surgery but before the 1 year visit.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| SN6AD1 | Uncorrected Intermediate Visual Acuity | 1 meter | 0.771 Decimal Visual Acuity |
| SN6AD1 | Uncorrected Intermediate Visual Acuity | 50 centimeters | 0.861 Decimal Visual Acuity |
Primary
Uncorrected Near Visual Acuity
Binocular Near Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction.
Time frame: 1 year after surgery
Population: One patient dropped out after the visit 6 months following surgery but before the 1 year visit.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| SN6AD1 | Uncorrected Near Visual Acuity | 1.082 Decimal Visual Acuity |