Trial Outcomes & Findings for Clinical Investigation of the AcrySof® IQ PanOptix™ IOL (NCT NCT03090256)
NCT ID: NCT03090256
Last Updated: 2019-09-24
Results Overview
Visual acuity (VA) was tested monocularly (each eye separately) under well-lit conditions with the subject's best spectacle correction 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. No hypothesis testing was planned for this study.
COMPLETED
NA
76 participants
Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantation
2019-09-24
Participant Flow
Subjects were recruited from 2 investigative sites located in Japan.
Of the 76 enrolled, 8 subjects were exited as screen failures prior to implantation. This reporting group includes all implanted subjects (68).
Participant milestones
| Measure |
TFNT00
AcrySof® IQ PanOptix™ IOL, bilateral implantation
|
|---|---|
|
Overall Study
STARTED
|
68
|
|
Overall Study
COMPLETED
|
68
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
TFNT00
n=68 Participants
AcrySof® IQ PanOptix™ IOL, bilateral implantation
|
|---|---|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 7.4 • n=68 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=68 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=68 Participants
|
PRIMARY outcome
Timeframe: Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantationPopulation: All-Implanted Analysis Set
Visual acuity (VA) was tested monocularly (each eye separately) under well-lit conditions with the subject's best spectacle correction 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. No hypothesis testing was planned for this study.
Outcome measures
| Measure |
First Eye
n=68 Eyes
AcrySof® IQ PanOptix™ IOL, first eye implantation
|
Second Eye
n=67 Eyes
AcrySof® IQ PanOptix™ IOL, second eye implantation
|
|---|---|---|
|
Monocular Photopic Best Corrected Distance Visual Acuity (5 m)
Visit 3/3A: 0.5 - < 0.7
|
0 subjects
|
0 subjects
|
|
Monocular Photopic Best Corrected Distance Visual Acuity (5 m)
Visit 0 preoperative: < 0.5
|
15 subjects
|
5 subjects
|
|
Monocular Photopic Best Corrected Distance Visual Acuity (5 m)
Visit 0 preoperative: 0.5 - < 0.7
|
9 subjects
|
8 subjects
|
|
Monocular Photopic Best Corrected Distance Visual Acuity (5 m)
Visit 0 preoperative: 0.7 - < 1.0
|
35 subjects
|
34 subjects
|
|
Monocular Photopic Best Corrected Distance Visual Acuity (5 m)
Visit 0 preoperative: 1.0 or better
|
9 subjects
|
20 subjects
|
|
Monocular Photopic Best Corrected Distance Visual Acuity (5 m)
Visit 1/1A: < 0.5
|
0 subjects
|
0 subjects
|
|
Monocular Photopic Best Corrected Distance Visual Acuity (5 m)
Visit 1/1A: 0.5 - < 0.7
|
1 subjects
|
0 subjects
|
|
Monocular Photopic Best Corrected Distance Visual Acuity (5 m)
Visit 1/1A: 0.7 - < 1.0
|
8 subjects
|
8 subjects
|
|
Monocular Photopic Best Corrected Distance Visual Acuity (5 m)
Visit 1/1A: 1.0 or better
|
59 subjects
|
59 subjects
|
|
Monocular Photopic Best Corrected Distance Visual Acuity (5 m)
Visit 2/2A: < 0.5
|
0 subjects
|
0 subjects
|
|
Monocular Photopic Best Corrected Distance Visual Acuity (5 m)
Visit 2/2A: 0.5 - < 0.7
|
0 subjects
|
0 subjects
|
|
Monocular Photopic Best Corrected Distance Visual Acuity (5 m)
Visit 2/2A: 0.7 - < 1.0
|
0 subjects
|
0 subjects
|
|
Monocular Photopic Best Corrected Distance Visual Acuity (5 m)
Visit 2/2A: 1.0 or better
|
68 subjects
|
67 subjects
|
|
Monocular Photopic Best Corrected Distance Visual Acuity (5 m)
Visit 3/3A: < 0.5
|
0 subjects
|
0 subjects
|
|
Monocular Photopic Best Corrected Distance Visual Acuity (5 m)
Visit 3/3A: 0.7 - < 1.0
|
2 subjects
|
1 subjects
|
|
Monocular Photopic Best Corrected Distance Visual Acuity (5 m)
Visit 3/3A: 1.0 or better
|
66 subjects
|
66 subjects
|
|
Monocular Photopic Best Corrected Distance Visual Acuity (5 m)
Visit 4A: < 0.5
|
0 subjects
|
0 subjects
|
|
Monocular Photopic Best Corrected Distance Visual Acuity (5 m)
Visit 4A: 0.5 - < 0.7
|
0 subjects
|
0 subjects
|
|
Monocular Photopic Best Corrected Distance Visual Acuity (5 m)
Visit 4A: 0.7 - < 1.0
|
2 subjects
|
2 subjects
|
|
Monocular Photopic Best Corrected Distance Visual Acuity (5 m)
Visit 4A: 1.0 or better
|
66 subjects
|
65 subjects
|
PRIMARY outcome
Timeframe: Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantationPopulation: All-Implanted Analysis Set
VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 60 cm is the VA at 60 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.
Outcome measures
| Measure |
First Eye
n=68 Eyes
AcrySof® IQ PanOptix™ IOL, first eye implantation
|
Second Eye
n=67 Eyes
AcrySof® IQ PanOptix™ IOL, second eye implantation
|
|---|---|---|
|
Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)
Visit 0 preoperative: < 0.5
|
47 subjects
|
40 subjects
|
|
Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)
Visit 0 preoperative: 0.5 - < 0.7
|
18 subjects
|
18 subjects
|
|
Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)
Visit 0 preoperative: 0.7 - < 1.0
|
1 subjects
|
8 subjects
|
|
Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)
Visit 0 preoperative: 1.0 or better
|
2 subjects
|
1 subjects
|
|
Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)
Visit 1/1A: < 0.5
|
2 subjects
|
1 subjects
|
|
Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)
Visit 1/1A: 0.5 - < 0.7
|
8 subjects
|
5 subjects
|
|
Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)
Visit 1/1A: 0.7 - < 1.0
|
21 subjects
|
25 subjects
|
|
Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)
Visit 1/1A: 1.0 or better
|
37 subjects
|
36 subjects
|
|
Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)
Visit 2/2A: < 0.5
|
0 subjects
|
0 subjects
|
|
Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)
Visit 2/2A: 0.5 - < 0.7
|
1 subjects
|
0 subjects
|
|
Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)
Visit 2/2A: 0.7 - < 1.0
|
13 subjects
|
7 subjects
|
|
Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)
Visit 2/2A: 1.0 or better
|
54 subjects
|
60 subjects
|
|
Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)
Visit 3/3A: < 0.5
|
0 subjects
|
0 subjects
|
|
Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)
Visit 3/3A: 0.5 - < 0.7
|
5 subjects
|
1 subjects
|
|
Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)
Visit 3/3A: 0.7 - < 1.0
|
5 subjects
|
8 subjects
|
|
Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)
Visit 3/3A: 1.0 or better
|
58 subjects
|
58 subjects
|
|
Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)
Visit 4A: < 0.5
|
2 subjects
|
1 subjects
|
|
Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)
Visit 4A: 0.5 - < 0.7
|
3 subjects
|
3 subjects
|
|
Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)
Visit 4A: 0.7 - < 1.0
|
4 subjects
|
7 subjects
|
|
Monocular Photopic Distance Corrected Intermediate Visual Acuity (60 cm)
Visit 4A: 1.0 or better
|
59 subjects
|
56 subjects
|
PRIMARY outcome
Timeframe: Visit 0 preoperative, Visit 1/1A (Day 1-2), Visit 2/2A (Day 7-14), Visit 3/3A (Day 30-60), Visit 4A (Day 120-180) post second implantationPopulation: All-Implanted Analysis Set
VA was tested monocularly under well-lit conditions using a chart. Distance-corrected VA at 40 cm is the VA at 40 cm measured under a corrected condition in which best-corrected VA at 5 m was obtained. VA was measured in decimal, with 1.0 decimal corresponding to 20/20 Snellen. A higher numeric value represents better visual acuity. No hypothesis testing was planned for this study.
Outcome measures
| Measure |
First Eye
n=68 Eyes
AcrySof® IQ PanOptix™ IOL, first eye implantation
|
Second Eye
n=67 Eyes
AcrySof® IQ PanOptix™ IOL, second eye implantation
|
|---|---|---|
|
Monocular Photopic Distance Corrected Near Visual Acuity (40 cm)
Visit 0 preoperative: < 0.4
|
48 subjects
|
40 subjects
|
|
Monocular Photopic Distance Corrected Near Visual Acuity (40 cm)
Visit 0 preoperative: 0.4 or better
|
20 subjects
|
27 subjects
|
|
Monocular Photopic Distance Corrected Near Visual Acuity (40 cm)
Visit 1/1A: < 0.4
|
1 subjects
|
0 subjects
|
|
Monocular Photopic Distance Corrected Near Visual Acuity (40 cm)
Visit 1/1A: 0.4 or better
|
67 subjects
|
67 subjects
|
|
Monocular Photopic Distance Corrected Near Visual Acuity (40 cm)
Visit 2/2A: < 0.4
|
0 subjects
|
0 subjects
|
|
Monocular Photopic Distance Corrected Near Visual Acuity (40 cm)
Visit 2/2A: 0.4 or better
|
68 subjects
|
67 subjects
|
|
Monocular Photopic Distance Corrected Near Visual Acuity (40 cm)
Visit 3/3A: < 0.4
|
0 subjects
|
0 subjects
|
|
Monocular Photopic Distance Corrected Near Visual Acuity (40 cm)
Visit 3/3A: 0.4 or better
|
68 subjects
|
67 subjects
|
|
Monocular Photopic Distance Corrected Near Visual Acuity (40 cm)
Visit 4A: < 0.4
|
2 subjects
|
1 subjects
|
|
Monocular Photopic Distance Corrected Near Visual Acuity (40 cm)
Visit 4A: 0.4 or better
|
66 subjects
|
66 subjects
|
Adverse Events
TFNT00
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Expert Clinical Project Lead, CDMA Surgical
Alcon Research
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