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Trial Outcomes & Findings for STAAR Visian Toric ICL Post-Approval Study (NCT NCT04516772)

NCT ID: NCT04516772

Last Updated: 2026-03-13

Results Overview

Rotation of the TICL of less than or equal to five degrees in 90% of treated eyes between 18 and 24 months postoperative

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

125 participants

Primary outcome timeframe

18 to 24 months postoperative

Results posted on

2026-03-13

Participant Flow

125 subjects were enrolled and treated at 8 clinical sites in the United States. The first enrolled subject underwent surgery in the primary eye on 21 Jul 2020 and the last (fellow) eye was implanted on 09 Nov 2022.

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure
Visian TICL
First and second (primary and fellow) implanted eyes of enrolled subjects. The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Overall Study
STARTED
125 232
Overall Study
COMPLETED
111 208
Overall Study
NOT COMPLETED
14 24

Reasons for withdrawal

Reasons for withdrawal
Measure
Visian TICL
First and second (primary and fellow) implanted eyes of enrolled subjects. The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Overall Study
Withdrawal by Subject
3
Overall Study
Lost to Follow-up
7
Overall Study
Adverse Event
4

Baseline Characteristics

STAAR Visian Toric ICL Post-Approval Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Visian TICL
n=232 Eyes
Enrolled patients who underwent surgery with a TICL lens in at least one eye.
Age, Categorical
<=18 years
0 Participants
n=41 Participants
Age, Categorical
Between 18 and 65 years
125 Participants
n=41 Participants
Age, Categorical
>=65 years
0 Participants
n=41 Participants
Sex: Female, Male
Female
77 Participants
n=41 Participants
Sex: Female, Male
Male
48 Participants
n=41 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=41 Participants
Race (NIH/OMB)
Asian
32 Participants
n=41 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=41 Participants
Race (NIH/OMB)
Black or African American
10 Participants
n=41 Participants
Race (NIH/OMB)
White
81 Participants
n=41 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=41 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=41 Participants
Region of Enrollment
United States
125 participants
n=41 Participants

PRIMARY outcome

Timeframe: 18 to 24 months postoperative

Population: The number of primary (first implanted) eyes with TICL rotation less than or equal to 5 degrees between 18 and 24 months postoperative.

Rotation of the TICL of less than or equal to five degrees in 90% of treated eyes between 18 and 24 months postoperative

Outcome measures

Outcome measures
Measure
Primary Eyes
n=108 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Change in Axis Orientation of the TICL
Less than 5 degrees rotation
104 Eyes
Change in Axis Orientation of the TICL
Missing
4 Eyes

SECONDARY outcome

Timeframe: Day 1 (1-2 days postoperatively)

Population: Safety Population

Absolute Rotation of the TICL in treated eyes between visits (change from Operative visit to Day 1)

Outcome measures

Outcome measures
Measure
Primary Eyes
n=210 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Absolute Rotation of the TICL Between Visits (Change From Operative Visit to Day 1)
1.30 degrees
Standard Deviation 1.90

SECONDARY outcome

Timeframe: Week 1 (5-9 days postoperatively)

Population: Safety Population

Absolute rotation of the TICL in treated eyes between visits (Change from Day 1 to Week 1)

Outcome measures

Outcome measures
Measure
Primary Eyes
n=207 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Absolute Rotation of the TICL Between Visits (Change From Day 1 to Week 1)
1.0 degrees
Standard Deviation 2.61

SECONDARY outcome

Timeframe: Month 1 (3-5 weeks postoperatively)

Population: Safety Population

Absolute rotation of the TICL in treated eyes between visits (Change from Week 1 to Month 1)

Outcome measures

Outcome measures
Measure
Primary Eyes
n=218 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Absolute Rotation of the TICL Between Visits (Change From Week 1 to Month 1)
1.0 degrees
Standard Deviation 5.81

SECONDARY outcome

Timeframe: Month 3 (10-14 weeks postoperatively)

Population: Safety Population

Absolute rotation of the TICL in treated eyes between visits (Change from Month 1 to Month 3)

Outcome measures

Outcome measures
Measure
Primary Eyes
n=220 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Absolute Rotation of the TICL Between Visits (Change From Month 1 to Month 3)
0.50 degrees
Standard Deviation 0.82

SECONDARY outcome

Timeframe: Month 6 (21 - 26 weeks postoperatively)

Population: Safety Population

Absolute rotation of the TICL in treated eyes between visits (Change from Month 3 to Month 6)

Outcome measures

Outcome measures
Measure
Primary Eyes
n=214 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Absolute Rotation of the TICL Between Visits (Change From Month 3 to Month 6)
0.50 degrees
Standard Deviation 0.42

SECONDARY outcome

Timeframe: Month 12 (11 - 14 months postoperatively)

Population: Safety Population

Absolute rotation of the TICL in treated eyes between visits (Change from Month 6 to Month 12)

Outcome measures

Outcome measures
Measure
Primary Eyes
n=211 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Absolute Rotation of the TICL Between Visits (Change From Month 6 to Month 12)
0.40 degrees
Standard Deviation 0.39

SECONDARY outcome

Timeframe: Month 18 (17 - 21 months postoperatively)

Population: Safety Population

Absolute rotation of the TICL in treated eyes between visits (Change from Month 12 to Month 18)

Outcome measures

Outcome measures
Measure
Primary Eyes
n=203 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Absolute Rotation of the TICL Between Visits (Change From Month 12 to Month 18)
0.30 degrees
Standard Deviation 0.28

SECONDARY outcome

Timeframe: Month 24 (23 - 27 months postoperatively)

Population: Safety Population

Absolute rotation of the TICL in treated eyes between visits (Change from Month 18 to Month 24)

Outcome measures

Outcome measures
Measure
Primary Eyes
n=197 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Absolute Rotation of the TICL Between Visits (Change From Month 18 to Month 24)
0.20 degrees
Standard Deviation 0.19

SECONDARY outcome

Timeframe: Operative Visit

Population: Safety Population

Absolute rotation of the TICL in treated eyes \<5 degrees, \<10 degrees, \<20 degrees, and \<30 degrees from the intended orientation at each visit

Outcome measures

Outcome measures
Measure
Primary Eyes
n=232 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Operative Visit)
<20 degrees
230 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Operative Visit)
<10 degrees
230 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Operative Visit)
<5 degrees
230 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Operative Visit)
<30 degrees
231 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Operative Visit)
≥ 30 degrees
1 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Operative Visit)
Missing
0 Eyes

SECONDARY outcome

Timeframe: Day 1 Visit

Population: Safety Population

Absolute rotation of the TICL in treated eyes \<5 degrees, \<10 degrees, \<20 degrees, and \<30 degrees from the intended orientation at each visit

Outcome measures

Outcome measures
Measure
Primary Eyes
n=230 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Absolute Rotation of the TICL <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Day 1)
<5 degrees
205 Eyes
Absolute Rotation of the TICL <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Day 1)
<10 degrees
206 Eyes
Absolute Rotation of the TICL <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Day 1)
<20 degrees
209 Eyes
Absolute Rotation of the TICL <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Day 1)
<30 degrees
210 Eyes
Absolute Rotation of the TICL <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Day 1)
≥ 30 degrees
0 Eyes
Absolute Rotation of the TICL <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Day 1)
Missing
20 Eyes

SECONDARY outcome

Timeframe: Week 1 Visit

Population: Safety Population

Absolute rotation of the TICL in treated eyes \<5 degrees, \<10 degrees, \<20 degrees, and \<30 degrees from the intended orientation at each visit

Outcome measures

Outcome measures
Measure
Primary Eyes
n=228 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Week 1 Visit)
<5 degrees
207 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Week 1 Visit)
<10 degrees
211 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Week 1 Visit)
<20 degrees
211 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Week 1 Visit)
<30 degrees
212 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Week 1 Visit)
≥ 30 degrees
1 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Week 1 Visit)
Missing
15 Eyes

SECONDARY outcome

Timeframe: Month 1 Visit

Population: Safety Population

Absolute rotation of the TICL in treated eyes \<5 degrees, \<10 degrees, \<20 degrees, and \<30 degrees from the intended orientation at each visit

Outcome measures

Outcome measures
Measure
Primary Eyes
n=227 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 1 Visit)
<5 degrees
210 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 1 Visit)
<10 degrees
213 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 1 Visit)
<20 degrees
214 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 1 Visit)
<30 degrees
215 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 1 Visit)
≥ 30 degrees
3 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 1 Visit)
Missing
9 Eyes

SECONDARY outcome

Timeframe: Month 3 Visit

Population: Safety Population

Absolute rotation of the TICL in treated eyes \<5 degrees, \<10 degrees, \<20 degrees, and \<30 degrees from the intended orientation at each visit

Outcome measures

Outcome measures
Measure
Primary Eyes
n=223 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 3 Visit)
<5 degrees
206 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 3 Visit)
<10 degrees
211 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 3 Visit)
<20 degrees
212 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 3 Visit)
<30 degrees
213 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 3 Visit)
≥ 30 degrees
2 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 3 Visit)
Missing
8 Eyes

SECONDARY outcome

Timeframe: Month 6 Visit

Population: Safety Population

Absolute rotation of the TICL in treated eyes \<5 degrees, \<10 degrees, \<20 degrees, and \<30 degrees from the intended orientation at each visit

Outcome measures

Outcome measures
Measure
Primary Eyes
n=217 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 6 Visit)
<5 degrees
199 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 6 Visit)
<10 degrees
205 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 6 Visit)
<20 degrees
207 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 6 Visit)
<30 degrees
208 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 6 Visit)
≥ 30 degrees
3 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 6 Visit)
Missing
6 Eyes

SECONDARY outcome

Timeframe: Month 12 Visit

Population: Safety Population

Absolute rotation of the TICL in treated eyes \<5 degrees, \<10 degrees, \<20 degrees, and \<30 degrees from the intended orientation at each visit

Outcome measures

Outcome measures
Measure
Primary Eyes
n=220 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 12 Visit)
<5 degrees
200 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 12 Visit)
<10 degrees
205 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 12 Visit)
<20 degrees
206 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 12 Visit)
<30 degrees
207 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 12 Visit)
≥ 30 degrees
3 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 12 Visit)
Missing
10 Eyes

SECONDARY outcome

Timeframe: Month 18 Visit

Population: Safety Population

Absolute rotation of the TICL in treated eyes \<5 degrees, \<10 degrees, \<20 degrees, and \<30 degrees from the intended orientation at each visit

Outcome measures

Outcome measures
Measure
Primary Eyes
n=212 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 18 Visit)
<5 degrees
193 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 18 Visit)
<10 degrees
198 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 18 Visit)
<20 degrees
200 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 18 Visit)
<30 degrees
201 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 18 Visit)
≥ 30 degrees
3 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 18 Visit)
Missing
8 Eyes

SECONDARY outcome

Timeframe: Month 24 Visit

Population: Safety Population

Absolute rotation of the TICL in treated eyes \<5 degrees, \<10 degrees, \<20 degrees, and \<30 degrees from the intended orientation at each visit

Outcome measures

Outcome measures
Measure
Primary Eyes
n=208 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 24 Visit)
<5 degrees
192 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 24 Visit)
<10 degrees
197 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 24 Visit)
<20 degrees
198 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 24 Visit)
<30 degrees
199 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 24 Visit)
≥ 30 degrees
1 Eyes
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 24 Visit)
Missing
8 Eyes

SECONDARY outcome

Timeframe: Operative Visit

Population: Safety Population

Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Operative Visit)

Outcome measures

Outcome measures
Measure
Primary Eyes
n=232 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Operative Visit)
0.30 degrees
Standard Deviation 2.80

SECONDARY outcome

Timeframe: Day 1 Visit

Population: Safety Population

Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Day 1 Visit)

Outcome measures

Outcome measures
Measure
Primary Eyes
n=230 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Day 1 Visit)
1.40 degrees
Standard Deviation 2.46

SECONDARY outcome

Timeframe: Week 1 Visit

Population: Safety Population

Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Week 1 Visit)

Outcome measures

Outcome measures
Measure
Primary Eyes
n=228 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Week 1 Visit)
1.60 degrees
Standard Deviation 3.06

SECONDARY outcome

Timeframe: Month 1 Visit

Population: Safety Population

Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 1 Visit)

Outcome measures

Outcome measures
Measure
Primary Eyes
n=227 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 1 Visit)
2.20 degrees
Standard Deviation 6.77

SECONDARY outcome

Timeframe: Month 3 Visit

Population: Safety Population

Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 3 Visit)

Outcome measures

Outcome measures
Measure
Primary Eyes
n=223 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 3 Visit)
1.80 degrees
Standard Deviation 3.90

SECONDARY outcome

Timeframe: Month 6 Visit

Population: Safety Population

Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 6 Visit)

Outcome measures

Outcome measures
Measure
Primary Eyes
n=217 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 6 Visit)
2.30 degrees
Standard Deviation 6.89

SECONDARY outcome

Timeframe: Month 12 Visit

Population: Safety Population

Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 12 Visit)

Outcome measures

Outcome measures
Measure
Primary Eyes
n=220 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month12 Visit)
2.30 degrees
Standard Deviation 6.84

SECONDARY outcome

Timeframe: Month 18 Visit

Population: Safety Population

Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 18 Visit)

Outcome measures

Outcome measures
Measure
Primary Eyes
n=212 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 18 Visit)
2.40 degrees
Standard Deviation 6.94

SECONDARY outcome

Timeframe: Month 24 Visit

Population: Safety Population

Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 24 Visit)

Outcome measures

Outcome measures
Measure
Primary Eyes
n=208 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 24 Visit)
1.80 degrees
Standard Deviation 3.36

SECONDARY outcome

Timeframe: Month 1

Population: Safety Population

Postoperative manifest refraction spherical equivalent (MRSE) at each visit

Outcome measures

Outcome measures
Measure
Primary Eyes
n=226 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Manifest Refraction Spherical Equivalent (MRSE) at Month 1
-0.20 diopter
Standard Deviation 0.38

SECONDARY outcome

Timeframe: Month 3

Population: Safety Population

Postoperative manifest refraction spherical equivalent (MRSE) at each visit

Outcome measures

Outcome measures
Measure
Primary Eyes
n=223 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Manifest Refraction Spherical Equivalent (MRSE) at Month 3
-0.19 diopter
Standard Deviation 0.36

SECONDARY outcome

Timeframe: Month 6

Population: Safety Population

Postoperative manifest refraction spherical equivalent (MRSE) at each visit

Outcome measures

Outcome measures
Measure
Primary Eyes
n=217 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Manifest Refraction Spherical Equivalent (MRSE) at Month 6
-0.21 diopter
Standard Deviation 0.36

SECONDARY outcome

Timeframe: Month 12

Population: Safety Population

Postoperative manifest refraction spherical equivalent (MRSE) at each visit

Outcome measures

Outcome measures
Measure
Primary Eyes
n=220 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Manifest Refraction Spherical Equivalent (MRSE) at Month 12
-0.23 diopter
Standard Deviation 0.36

SECONDARY outcome

Timeframe: Month 18

Population: Safety Population

Postoperative manifest refraction spherical equivalent (MRSE) at each visit

Outcome measures

Outcome measures
Measure
Primary Eyes
n=212 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Manifest Refraction Spherical Equivalent (MRSE) at Month 18
-0.21 diopter
Standard Deviation 0.32

SECONDARY outcome

Timeframe: Month 24

Population: Safety Population

Postoperative manifest refraction spherical equivalent (MRSE) at each visit

Outcome measures

Outcome measures
Measure
Primary Eyes
n=208 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Manifest Refraction Spherical Equivalent (MRSE) at Month 24
-0.19 diopter
Standard Deviation 0.31

SECONDARY outcome

Timeframe: Month 1

Population: Safety Population

Postoperative manifest refraction cylinder at each visit

Outcome measures

Outcome measures
Measure
Primary Eyes
n=226 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Manifest Refraction Cylinder at Month 1
-0.54 diopter
Standard Deviation 0.42

SECONDARY outcome

Timeframe: Month 3

Population: Safety Population

Postoperative manifest refraction cylinder at each visit

Outcome measures

Outcome measures
Measure
Primary Eyes
n=223 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Manifest Refraction Cylinder at Month 3
-0.55 diopter
Standard Deviation 0.43

SECONDARY outcome

Timeframe: Month 6

Population: Safety Population

Postoperative manifest refraction cylinder at each visit

Outcome measures

Outcome measures
Measure
Primary Eyes
n=217 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Manifest Refraction Cylinder at Month 6
-0.50 diopter
Standard Deviation 0.44

SECONDARY outcome

Timeframe: Month 12

Population: Safety Population

Postoperative manifest refraction cylinder at each visit

Outcome measures

Outcome measures
Measure
Primary Eyes
n=220 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Manifest Refraction Cylinder at Month 12
-0.47 diopter
Standard Deviation 0.45

SECONDARY outcome

Timeframe: Month 18

Population: Safety Population

Postoperative manifest refraction cylinder at each visit

Outcome measures

Outcome measures
Measure
Primary Eyes
n=212 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Manifest Refraction Cylinder at Month 18
-0.43 diopter
Standard Deviation 0.44

SECONDARY outcome

Timeframe: Month 24

Population: Safety Population

Postoperative manifest refraction cylinder at each visit

Outcome measures

Outcome measures
Measure
Primary Eyes
n=208 Eyes
First implanted eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Manifest Refraction Cylinder at Month 24
-0.41 diopter
Standard Deviation 0.44

Adverse Events

All Eyes

Serious events: 29 serious events
Other events: 40 other events
Deaths: 0 deaths

Non-Ocular Serious Adverse Events

Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
All Eyes
n=232 participants at risk
All implanted (treated) eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Non-Ocular Serious Adverse Events
n=125 participants at risk
Participants who experienced a non-ocular Serious Adverse Event.
Eye disorders
Intraocular pressure increased
3.9%
9/232 • Number of events 11 • 24 months
Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. Secondary surgical interventions (SSIs) performed to treat the ocular SAEs were also reported as SAEs in this study and are described within the device Directions for Use.
0.00%
0/125 • 24 months
Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. Secondary surgical interventions (SSIs) performed to treat the ocular SAEs were also reported as SAEs in this study and are described within the device Directions for Use.
Eye disorders
Residual refractive error
4.3%
10/232 • Number of events 10 • 24 months
Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. Secondary surgical interventions (SSIs) performed to treat the ocular SAEs were also reported as SAEs in this study and are described within the device Directions for Use.
0.00%
0/125 • 24 months
Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. Secondary surgical interventions (SSIs) performed to treat the ocular SAEs were also reported as SAEs in this study and are described within the device Directions for Use.
Eye disorders
Narrow anterior chamber angle
2.6%
6/232 • Number of events 6 • 24 months
Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. Secondary surgical interventions (SSIs) performed to treat the ocular SAEs were also reported as SAEs in this study and are described within the device Directions for Use.
0.00%
0/125 • 24 months
Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. Secondary surgical interventions (SSIs) performed to treat the ocular SAEs were also reported as SAEs in this study and are described within the device Directions for Use.
Eye disorders
Pupillary block
2.2%
5/232 • Number of events 5 • 24 months
Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. Secondary surgical interventions (SSIs) performed to treat the ocular SAEs were also reported as SAEs in this study and are described within the device Directions for Use.
0.00%
0/125 • 24 months
Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. Secondary surgical interventions (SSIs) performed to treat the ocular SAEs were also reported as SAEs in this study and are described within the device Directions for Use.
Eye disorders
Residual cylindrical refractive error (due to TMICL misalignment)
1.7%
4/232 • Number of events 4 • 24 months
Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. Secondary surgical interventions (SSIs) performed to treat the ocular SAEs were also reported as SAEs in this study and are described within the device Directions for Use.
0.00%
0/125 • 24 months
Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. Secondary surgical interventions (SSIs) performed to treat the ocular SAEs were also reported as SAEs in this study and are described within the device Directions for Use.
Eye disorders
Eye pain
0.43%
1/232 • Number of events 1 • 24 months
Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. Secondary surgical interventions (SSIs) performed to treat the ocular SAEs were also reported as SAEs in this study and are described within the device Directions for Use.
0.00%
0/125 • 24 months
Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. Secondary surgical interventions (SSIs) performed to treat the ocular SAEs were also reported as SAEs in this study and are described within the device Directions for Use.
Eye disorders
Increase in cylindrical refractive error (due to TMICL rotation)
0.43%
1/232 • Number of events 1 • 24 months
Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. Secondary surgical interventions (SSIs) performed to treat the ocular SAEs were also reported as SAEs in this study and are described within the device Directions for Use.
0.00%
0/125 • 24 months
Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. Secondary surgical interventions (SSIs) performed to treat the ocular SAEs were also reported as SAEs in this study and are described within the device Directions for Use.
Eye disorders
Posterior subcapsular cataract
0.43%
1/232 • Number of events 1 • 24 months
Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. Secondary surgical interventions (SSIs) performed to treat the ocular SAEs were also reported as SAEs in this study and are described within the device Directions for Use.
0.00%
0/125 • 24 months
Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. Secondary surgical interventions (SSIs) performed to treat the ocular SAEs were also reported as SAEs in this study and are described within the device Directions for Use.
Eye disorders
Intraocular lens dislocation
0.43%
1/232 • Number of events 1 • 24 months
Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. Secondary surgical interventions (SSIs) performed to treat the ocular SAEs were also reported as SAEs in this study and are described within the device Directions for Use.
0.00%
0/125 • 24 months
Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. Secondary surgical interventions (SSIs) performed to treat the ocular SAEs were also reported as SAEs in this study and are described within the device Directions for Use.
Gastrointestinal disorders
Gastric ulcers
0.00%
0/232 • 24 months
Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. Secondary surgical interventions (SSIs) performed to treat the ocular SAEs were also reported as SAEs in this study and are described within the device Directions for Use.
0.80%
1/125 • Number of events 1 • 24 months
Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. Secondary surgical interventions (SSIs) performed to treat the ocular SAEs were also reported as SAEs in this study and are described within the device Directions for Use.
Vascular disorders
Internal carotid artery aneurysm
0.00%
0/232 • 24 months
Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. Secondary surgical interventions (SSIs) performed to treat the ocular SAEs were also reported as SAEs in this study and are described within the device Directions for Use.
0.80%
1/125 • Number of events 1 • 24 months
Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. Secondary surgical interventions (SSIs) performed to treat the ocular SAEs were also reported as SAEs in this study and are described within the device Directions for Use.

Other adverse events

Other adverse events
Measure
All Eyes
n=232 participants at risk
All implanted (treated) eyes of enrolled patients. Visian TICL: The investigational lenses are intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Non-Ocular Serious Adverse Events
n=125 participants at risk
Participants who experienced a non-ocular Serious Adverse Event.
Eye disorders
Intraocular pressure increased
17.2%
40/232 • Number of events 49 • 24 months
Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. Secondary surgical interventions (SSIs) performed to treat the ocular SAEs were also reported as SAEs in this study and are described within the device Directions for Use.
—
0/0 • 24 months
Serious Adverse events (SAEs) (ocular and non-ocular) were collected. Non-serious non-ocular adverse events were not collected. Secondary surgical interventions (SSIs) performed to treat the ocular SAEs were also reported as SAEs in this study and are described within the device Directions for Use.

Additional Information

Joanne Egamino

STAAR Surgical

Phone: 626-303-7902

Results disclosure agreements

  • Principal investigator is a sponsor employee All data generated from the study will be regarded as confidential, until appropriate analysis and review by the Sponsor or its designee are completed. The results of the study may be published or presented by the Investigator(s) after review by, and in consultation and agreement with the Sponsor, and such that confidential or proprietary information is not disclosed. Prior to publication or presentation, a copy of the final text should be forwarded to Sponsor or designee for comment.
  • Publication restrictions are in place

Restriction type: OTHER