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
Not provided
Not provided
The purpose of this study is to evaluate safety and effectiveness of AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Models SND1T3, SND1T4, SND1T5, and SND1T6 when implanted to replace the natural lens in Japanese cataract patients.
Eligible participants completed a preoperative examination of both eyes, implantation of the IOL at the operative visit for each eye, and up to 8 postoperative visits: Day 1-2, Day 7-14, and Day 30-60 after each implantation, and Day 120-180 and Day 330-420 after second eye implantation. The second implantation occurred within 30 days of the first.The primary eye was defined as the eye with higher astigmatism, with the other eye defined as the secondary eye. If both eyes had the same level of astigmatism, the first implanted eye was set as the primary eye.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ReSTOR +3.0 | Experimental | AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL | Device | Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient |
| Measure | Description | Time Frame |
|---|---|---|
| Monocular Uncorrected Distance Decimal Visual Acuity | Visual acuity (VA) was tested monocularly (each eye separately) unaided at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. | Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 |
| Monocular Uncorrected Near Decimal VA | VA was tested monocularly unaided at a distance of 40 centimeters (cm) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. | Day 30-60, Day 120-180, Day 330-420 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Group Manager, Surgical | Alcon Japan, Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo Dental College Suidobashi Hospital | Chiyoda-ku | Tokyo | 101-0061 | Japan | ||
| Hayashi Eye Hospital |
This reporting group includes all implanted subjects (65).
Subjects were recruited from 2 study sites located in Japan.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ReSTOR +3.0 | AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This analysis population includes all implanted subjects.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ReSTOR +3.0 | AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation |
| 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 | Monocular Uncorrected Distance Decimal Visual Acuity | Visual acuity (VA) was tested monocularly (each eye separately) unaided at a distance of 5 meters (m) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. | This analysis population includes all implanted subjects. | Posted | Number | participants | Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420 |
|
This reporting group includes all implanted subjects.
An Adverse Event (AE) was defined as any untoward medical occurrence in a subject, user or other persons regardless of whether or not the event has a causal relationship with the medical device(s) or test procedure(s) in the study. AEs were collected as solicited comments from the subject and as observations by the study Investigator as outlined in the protocol.
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 | ReSTOR +3.0 | AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation paroxysmal | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Group Manager, Surgical | Alcon Japan, Ltd. | 1-888-451-3937 | alcon.medinfo@alcon.com |
Not provided
| ID | Term |
|---|---|
| D002386 | Cataract |
| D001251 | Astigmatism |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Fukuoka |
| 812-0011 |
| Japan |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Day 30-60 | AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism |
| OG003 | Day 120-180 | AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism |
| OG004 | Day 330-420 | AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism |
|
|
| Primary | Monocular Uncorrected Near Decimal VA | VA was tested monocularly unaided at a distance of 40 centimeters (cm) using a chart. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. | This analysis population includes all implanted subjects. | Posted | Number | participants | Day 30-60, Day 120-180, Day 330-420 |
|
|
|
| 8 |
| 65 |
| 0 |
| 65 |
| Endophthalmitis (Primary Eye) | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
|
| Eighth rib fracture | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
|
| Gonarthrosis | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
|
| Carcinoma hepatocellular | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
|
| Oropharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
|
| Secondary surgical intervention (Primary Eye) | Surgical and medical procedures | MedDRA (15.1) | Systematic Assessment |
|
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
|
| Secondary eye worse than 0.4 decimal |
|
| Secondary eye 0.4 decimal or better |
|