Trial Outcomes & Findings for AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL) Clinical Study in Japan (NCT NCT01323777)
NCT ID: NCT01323777
Last Updated: 2018-07-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420
Results posted on
2018-07-02
Participant Flow
Subjects were recruited from 2 study sites located in Japan.
This reporting group includes all implanted subjects (65).
Participant milestones
| Measure |
ReSTOR +3.0
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
|
|---|---|
|
Overall Study
STARTED
|
65
|
|
Overall Study
COMPLETED
|
65
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric Intraocular Lens (IOL) Clinical Study in Japan
Baseline characteristics by cohort
| Measure |
ReSTOR +3.0
n=65 Participants
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
|
|---|---|
|
Age, Continuous
|
66.4 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Age, Customized
<60 years
|
12 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
24 participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
25 participants
n=5 Participants
|
|
Age, Customized
≥ 80 years
|
4 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
65 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1-2, Day 7-14, Day 30-60, Day 120-180, Day 330-420Population: This analysis population includes all implanted subjects.
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.
Outcome measures
| Measure |
Day 1-2
n=65 Participants
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
|
Day 7-14
n=65 Participants
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
|
Day 30-60
n=65 Participants
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
|
Day 120-180
n=65 Participants
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
|
Day 330-420
n=65 Participants
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
|
|---|---|---|---|---|---|
|
Monocular Uncorrected Distance Decimal Visual Acuity
Primary eye 1.0 decimal or better
|
21 participants
|
31 participants
|
28 participants
|
35 participants
|
31 participants
|
|
Monocular Uncorrected Distance Decimal Visual Acuity
Secondary eye worse than 0.5 decimal
|
5 participants
|
1 participants
|
3 participants
|
1 participants
|
0 participants
|
|
Monocular Uncorrected Distance Decimal Visual Acuity
Primary eye worse than 0.5 decimal
|
3 participants
|
3 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Monocular Uncorrected Distance Decimal Visual Acuity
Primary eye 0.5 to less than 0.7 decimal
|
12 participants
|
4 participants
|
6 participants
|
3 participants
|
5 participants
|
|
Monocular Uncorrected Distance Decimal Visual Acuity
Primary eye 0.7 to less than 1.0 decimal
|
29 participants
|
27 participants
|
30 participants
|
27 participants
|
28 participants
|
|
Monocular Uncorrected Distance Decimal Visual Acuity
Secondary eye 0.5 to less than 0.7 decimal
|
14 participants
|
7 participants
|
2 participants
|
6 participants
|
6 participants
|
|
Monocular Uncorrected Distance Decimal Visual Acuity
Secondary eye 0.7 to less than 1.0 decimal
|
21 participants
|
22 participants
|
28 participants
|
28 participants
|
27 participants
|
|
Monocular Uncorrected Distance Decimal Visual Acuity
Secondary eye 1.0 decimal or better
|
25 participants
|
35 participants
|
32 participants
|
30 participants
|
32 participants
|
PRIMARY outcome
Timeframe: Day 30-60, Day 120-180, Day 330-420Population: This analysis population includes all implanted subjects.
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.
Outcome measures
| Measure |
Day 1-2
n=65 Participants
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
|
Day 7-14
n=65 Participants
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
|
Day 30-60
n=65 Participants
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
|
Day 120-180
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
|
Day 330-420
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
|
|---|---|---|---|---|---|
|
Monocular Uncorrected Near Decimal VA
Primary eye worse than 0.4 decimal
|
1 participants
|
0 participants
|
1 participants
|
—
|
—
|
|
Monocular Uncorrected Near Decimal VA
Primary eye 0.4 decimal or better
|
64 participants
|
65 participants
|
64 participants
|
—
|
—
|
|
Monocular Uncorrected Near Decimal VA
Secondary eye worse than 0.4 decimal
|
1 participants
|
1 participants
|
0 participants
|
—
|
—
|
|
Monocular Uncorrected Near Decimal VA
Secondary eye 0.4 decimal or better
|
64 participants
|
64 participants
|
65 participants
|
—
|
—
|
Adverse Events
ReSTOR +3.0
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ReSTOR +3.0
n=65 participants at risk
AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
|
|---|---|
|
Cardiac disorders
Atrial fibrillation paroxysmal
|
1.5%
1/65 • 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.
|
|
Infections and infestations
Endophthalmitis (Primary Eye)
|
1.5%
1/65 • 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.
|
|
Injury, poisoning and procedural complications
Eighth rib fracture
|
1.5%
1/65 • 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.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.5%
1/65 • 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.
|
|
Musculoskeletal and connective tissue disorders
Gonarthrosis
|
1.5%
1/65 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma hepatocellular
|
1.5%
1/65 • 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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer
|
1.5%
1/65 • 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.
|
|
Nervous system disorders
Carotid artery stenosis
|
1.5%
1/65 • 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.
|
|
Nervous system disorders
Cerebral infarction
|
1.5%
1/65 • 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.
|
|
Surgical and medical procedures
Secondary surgical intervention (Primary Eye)
|
3.1%
2/65 • 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.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER