Trial Outcomes & Findings for Clinical Investigation of an AcrySof IQ PanOptix Toric Intraocular Lens (NCT NCT04542525)
NCT ID: NCT04542525
Last Updated: 2022-08-17
Results Overview
A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
32 participants
Primary outcome timeframe
Day 30-60 postoperative
Results posted on
2022-08-17
Participant Flow
Subjects were recruited from 1 investigative site located in Japan.
This reporting group includes all enrolled participants.
Unit of analysis: eyes
Participant milestones
| Measure |
PanOptix Toric Trifocal IOL
ACRYSOF IQ PanOptix Toric Trifocal IOL Model TFNT20 implanted in the capsular bag in the posterior chamber following cataract surgery
|
|---|---|
|
Overall Study
STARTED
|
32 41
|
|
Overall Study
Attempted Implantation
|
32 41
|
|
Overall Study
Successful Implantation
|
32 41
|
|
Overall Study
COMPLETED
|
32 41
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Investigation of an AcrySof IQ PanOptix Toric Intraocular Lens
Baseline characteristics by cohort
| Measure |
PanOptix Toric Trifocal IOL
n=32 Participants
ACRYSOF IQ PanOptix Toric Trifocal IOL Model TFNT20 implanted in the capsular bag in the posterior chamber following cataract surgery
|
|---|---|
|
Age, Continuous
|
65.2 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Age, Customized
Less than 60 years
|
8 participants
n=5 Participants
|
|
Age, Customized
60-69 years
|
10 participants
n=5 Participants
|
|
Age, Customized
70-79 years
|
13 participants
n=5 Participants
|
|
Age, Customized
80 years and older
|
1 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
32 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
32 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 30-60 postoperativePopulation: All Implanted Analysis Set
A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism.
Outcome measures
| Measure |
PanOptix Toric Trifocal IOL
n=41 eyes
ACRYSOF IQ PanOptix Toric Trifocal IOL Model TFNT20 implanted in the capsular bag in the posterior chamber following cataract surgery
|
|---|---|
|
Percentage of Eyes With ≤ 0.25 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)
|
90.2 percentage of eyes
|
SECONDARY outcome
Timeframe: Day 30-60 postoperativePopulation: All Implanted Analysis Set
A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism. No confirmatory statistical hypothesis testing was pre-specified in the protocol.
Outcome measures
| Measure |
PanOptix Toric Trifocal IOL
n=41 eyes
ACRYSOF IQ PanOptix Toric Trifocal IOL Model TFNT20 implanted in the capsular bag in the posterior chamber following cataract surgery
|
|---|---|
|
Percentage of Eyes With ≤ 0.5 Diopter (D) Absolute Refractive Cylinder at Visit 3/3A (Day 30-60)
|
100 percentage of eyes
|
SECONDARY outcome
Timeframe: Day 30-60 postoperativePopulation: All Implanted Analysis Set
A manifest refraction (manual vision test) was conducted using charts. Refractive cylinder is the amount of power in diopters that is needed to correct any remaining astigmatism. No confirmatory statistical hypothesis testing was pre-specified in the protocol.
Outcome measures
| Measure |
PanOptix Toric Trifocal IOL
n=41 eyes
ACRYSOF IQ PanOptix Toric Trifocal IOL Model TFNT20 implanted in the capsular bag in the posterior chamber following cataract surgery
|
|---|---|
|
Average Absolute Manifest Refractive Cylinder at Visit 3/3A (Day 30-60)
|
0.055 diopter
Standard Deviation 0.153
|
Adverse Events
Pretreatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
TFNT20 Ocular / First Eye
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
TFNT20 Ocular / Second Eye
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
TFNT20 Nonocular / Systemic
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 |
Pretreatment
n=32 participants at risk
Events reported in this group occurred prior to attempted implantation with the test article
|
TFNT20 Ocular / First Eye
n=32 participants at risk
Events reported in this group occurred after attempted implantation with the test article and include ocular events in the study eye
|
TFNT20 Ocular / Second Eye
n=9 participants at risk
Events reported in this group occurred after attempted implantation with the test article and include ocular events in the study eye
|
TFNT20 Nonocular / Systemic
n=32 participants at risk
Events reported in this group occurred after attempted implantation with the test article
|
|---|---|---|---|---|
|
Investigations
Intraocular pressure increased
|
0.00%
0/32 • Adverse events (AEs) were collected pre-treatment (Day -60 to 0) up to Day 30-60 post-treatment/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.
|
15.6%
5/32 • Adverse events (AEs) were collected pre-treatment (Day -60 to 0) up to Day 30-60 post-treatment/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.
|
11.1%
1/9 • Adverse events (AEs) were collected pre-treatment (Day -60 to 0) up to Day 30-60 post-treatment/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.
|
0.00%
0/32 • Adverse events (AEs) were collected pre-treatment (Day -60 to 0) up to Day 30-60 post-treatment/study exit. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator.
This analysis population includes all subjects/eyes with attempted implantation with the test article (successful or aborted after contact with the eye). "At Risk" population of pre-treatment and systemic AEs is reported in units of subjects; ocular AE population is reported in units of eyes.
|
Additional Information
Director of Clinical Projects, Surgical
Alcon Research, LLC
Phone: +1-817-909-6199
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