Trial Outcomes & Findings for Corrected VA With Long-Term Follow-Up After AcrySof® Intraocular Lens (IOL) Implantation (NCT NCT02450799)
NCT ID: NCT02450799
Last Updated: 2016-12-09
Results Overview
Measurement of best corrected (with spectacles or other visual corrective devices) visual acuity (at both near and distance). Visual Acuity (VA) is measured in logMAR (logarithm of the minimum angle of resolution). A lower logMAR value indicates better visual acuity. One eye (study eye) contributed to the analysis.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
104 participants
Primary outcome timeframe
Baseline (up to and including 3 months after implantation), long-term post-implantation visit (14-20 years after implantation)
Results posted on
2016-12-09
Participant Flow
Subjects were recruited from 11 study centers located in Japan.
Of the 104 enrolled, 6 subjects were exited as screen failures and deemed ineligible for participation. This reporting group includes all eligible subjects (98).
Participant milestones
| Measure |
AcrySof
Acrylic IOL, prior implantation (1994-2000) in one or both eyes
|
Silicone
Silicone IOL, prior implantation (1994-2000) in one or both eyes
|
PMMA
Polymethylmethacrylate (PMMA) IOL, prior implantation (1994-2000) in one or both eyes
|
|---|---|---|---|
|
Overall Study
STARTED
|
31
|
37
|
30
|
|
Overall Study
COMPLETED
|
31
|
37
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Corrected VA With Long-Term Follow-Up After AcrySof® Intraocular Lens (IOL) Implantation
Baseline characteristics by cohort
| Measure |
AcrySof
n=31 Participants
Acrylic IOL, prior implantation (1994-2000) in one or both eyes
|
Silicone
n=37 Participants
Silicone IOL, prior implantation (1994-2000) in one or both eyes
|
PMMA
n=30 Participants
Polymethylmethacrylate IOL, prior implantation (1994-2000) in one or both eyes
|
Total
n=98 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
<70 years
|
2 subjects
n=5 Participants
|
4 subjects
n=7 Participants
|
6 subjects
n=5 Participants
|
12 subjects
n=4 Participants
|
|
Age, Customized
≥70 and ≤79 years
|
13 subjects
n=5 Participants
|
21 subjects
n=7 Participants
|
11 subjects
n=5 Participants
|
45 subjects
n=4 Participants
|
|
Age, Customized
≥80 and ≤89 years
|
12 subjects
n=5 Participants
|
12 subjects
n=7 Participants
|
9 subjects
n=5 Participants
|
33 subjects
n=4 Participants
|
|
Age, Customized
>90 years
|
4 subjects
n=5 Participants
|
0 subjects
n=7 Participants
|
4 subjects
n=5 Participants
|
8 subjects
n=4 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
32 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline (up to and including 3 months after implantation), long-term post-implantation visit (14-20 years after implantation)Population: This analysis population includes all subjects who used the study devices and have data after implantation of study devices (Full Analysis Set).
Measurement of best corrected (with spectacles or other visual corrective devices) visual acuity (at both near and distance). Visual Acuity (VA) is measured in logMAR (logarithm of the minimum angle of resolution). A lower logMAR value indicates better visual acuity. One eye (study eye) contributed to the analysis.
Outcome measures
| Measure |
AcrySof
n=31 Participants
Acrylic IOL, prior implantation (1994-2000) in one or both eyes
|
Silicone
n=37 Participants
Silicone IOL, prior implantation (1994-2000) in one or both eyes
|
PMMA
n=30 Participants
Polymethylmethacrylate IOL, prior implantation (1994-2000) in one or both eyes
|
|---|---|---|---|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit
Baseline
|
-0.06 logMAR
Standard Deviation 0.07
|
-0.09 logMAR
Standard Deviation 0.07
|
-0.07 logMAR
Standard Deviation 0.08
|
|
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at the Long-Term, Post-Implantation Visit
Change from baseline
|
0.01 logMAR
Standard Deviation 0.08
|
0.04 logMAR
Standard Deviation 0.06
|
-0.01 logMAR
Standard Deviation 0.05
|
Adverse Events
AcrySof (Retrospective)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Silicone (Retrospective)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
PMMA (Retrospective)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
AcrySof (Prospective)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Silicone (Prospective)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PMMA (Prospective)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AcrySof (Retrospective)
n=31 participants at risk
Subjects with prior implantation of acrylic IOL who experienced an AE related to decrease of BCVA in the study eye
|
Silicone (Retrospective)
n=37 participants at risk
Subjects with prior implantation of Silicone IOL who experienced an AE related to decrease of BCVA in the study eye
|
PMMA (Retrospective)
n=30 participants at risk
Subjects with prior implantation of PMMA IOL who experienced an AE related to decrease of BCVA in the study eye
|
AcrySof (Prospective)
n=31 participants at risk
Subjects with prior implantation of acrylic IOL who experienced an AE with onset after the Informed Consent acquisition
|
Silicone (Prospective)
n=37 participants at risk
Subjects with prior implantation of Silicone IOL who experienced an AE with onset after the Informed Consent acquisition
|
PMMA (Prospective)
n=30 participants at risk
Subjects with prior implantation of PMMA IOL who experienced an AE with onset after the Informed Consent acquisition
|
|---|---|---|---|---|---|---|
|
Eye disorders
posterior capsule opacification
|
0.00%
0/31 • Adverse events (AEs) were collected for the duration of a subject's participation in the study; retrospectively 14 to 20 years and prospectively for a single visit. This analysis group includes all subjects who used the study devices and underwent the long-term post-implantation visit examination. Ocular adverse events are presented for both study eye and non-study eye combined.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, whether or not related to the investigational medical device (test/control article or procedure). AEs are reported retrospectively (onset between Baseline (defined as the period within 3 months after surgery) and Informed Consent acquisition) and prospectively (onset after Informed Consent acquisition).
|
8.1%
3/37 • Adverse events (AEs) were collected for the duration of a subject's participation in the study; retrospectively 14 to 20 years and prospectively for a single visit. This analysis group includes all subjects who used the study devices and underwent the long-term post-implantation visit examination. Ocular adverse events are presented for both study eye and non-study eye combined.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, whether or not related to the investigational medical device (test/control article or procedure). AEs are reported retrospectively (onset between Baseline (defined as the period within 3 months after surgery) and Informed Consent acquisition) and prospectively (onset after Informed Consent acquisition).
|
13.3%
4/30 • Adverse events (AEs) were collected for the duration of a subject's participation in the study; retrospectively 14 to 20 years and prospectively for a single visit. This analysis group includes all subjects who used the study devices and underwent the long-term post-implantation visit examination. Ocular adverse events are presented for both study eye and non-study eye combined.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, whether or not related to the investigational medical device (test/control article or procedure). AEs are reported retrospectively (onset between Baseline (defined as the period within 3 months after surgery) and Informed Consent acquisition) and prospectively (onset after Informed Consent acquisition).
|
0.00%
0/31 • Adverse events (AEs) were collected for the duration of a subject's participation in the study; retrospectively 14 to 20 years and prospectively for a single visit. This analysis group includes all subjects who used the study devices and underwent the long-term post-implantation visit examination. Ocular adverse events are presented for both study eye and non-study eye combined.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, whether or not related to the investigational medical device (test/control article or procedure). AEs are reported retrospectively (onset between Baseline (defined as the period within 3 months after surgery) and Informed Consent acquisition) and prospectively (onset after Informed Consent acquisition).
|
0.00%
0/37 • Adverse events (AEs) were collected for the duration of a subject's participation in the study; retrospectively 14 to 20 years and prospectively for a single visit. This analysis group includes all subjects who used the study devices and underwent the long-term post-implantation visit examination. Ocular adverse events are presented for both study eye and non-study eye combined.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, whether or not related to the investigational medical device (test/control article or procedure). AEs are reported retrospectively (onset between Baseline (defined as the period within 3 months after surgery) and Informed Consent acquisition) and prospectively (onset after Informed Consent acquisition).
|
0.00%
0/30 • Adverse events (AEs) were collected for the duration of a subject's participation in the study; retrospectively 14 to 20 years and prospectively for a single visit. This analysis group includes all subjects who used the study devices and underwent the long-term post-implantation visit examination. Ocular adverse events are presented for both study eye and non-study eye combined.
An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, whether or not related to the investigational medical device (test/control article or procedure). AEs are reported retrospectively (onset between Baseline (defined as the period within 3 months after surgery) and Informed Consent acquisition) and prospectively (onset after Informed Consent acquisition).
|
Additional Information
Phase IV, Clinical and Regulatory Affairs, Alcon Japan
Alcon, A Novartis Division
Phone: 1-888-451-3937
Email: [email protected]
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