Myopic Astigmatism
Conditions
Keywords
nearsightedness, phakic IOL, Toric ICL, TICL, TMICL, Visian, astigmatism
Brief summary
The objective of this study is to evaluate the long term (i.e. 24 months) clinical performance of the Visian® Toric Implantable Collamer® Lens (ICL).
Detailed description
This study will be conducted at 6-8 clinical sites in the US, by surgeons qualified by experience and training to implant Visian Toric ICLs.
Interventions
DEVICEVisian TICL
The Visian TICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Sponsors
Staar Surgical Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All enrolled subjects will undergo phakic eye surgery to have the STAAR Visian Toric Implantable Collamer Lens (TICL) implanted in one or both eligible eyes.
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Moderate to high myopia with astigmatism correctable with available TICL powers. * Stable refractive history within 0.50 D each cylinder and spherical equivalent (SE) for 1 year prior to implantation. * Able and willing to return for scheduled follow-up examinations after surgery. * Able to read, understand and provide written informed consent on the Institutional Review Board (IRB)-approved informed consent form (ICF) and provide authorization as appropriate for local privacy regulations. * Other protocol-specified inclusion criteria may apply.
Exclusion criteria
* Insulin-dependent diabetes or diabetic retinopathy. * History of previous ocular surgery. * Cataract of any grade. * Monocular. * Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Axis Orientation of the TICL | 18 to 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Manifest Refraction Spherical Equivalent (MRSE) at Month 18 | Month 18 | Postoperative manifest refraction spherical equivalent (MRSE) at each visit |
| Absolute Rotation of the TICL Between Visits (Change From Operative Visit to Day 1) | Day 1 (1-2 days postoperatively) | Absolute Rotation of the TICL in treated eyes between visits (change from Operative visit to Day 1) |
| Absolute Rotation of the TICL Between Visits (Change From Week 1 to Month 1) | Month 1 (3-5 weeks postoperatively) | Absolute rotation of the TICL in treated eyes between visits (Change from Week 1 to Month 1) |
| Absolute Rotation of the TICL Between Visits (Change From Month 1 to Month 3) | Month 3 (10-14 weeks postoperatively) | Absolute rotation of the TICL in treated eyes between visits (Change from Month 1 to Month 3) |
| Absolute Rotation of the TICL Between Visits (Change From Month 3 to Month 6) | Month 6 (21 - 26 weeks postoperatively) | Absolute rotation of the TICL in treated eyes between visits (Change from Month 3 to Month 6) |
| Absolute Rotation of the TICL Between Visits (Change From Month 6 to Month 12) | Month 12 (11 - 14 months postoperatively) | Absolute rotation of the TICL in treated eyes between visits (Change from Month 6 to Month 12) |
| Absolute Rotation of the TICL Between Visits (Change From Month 12 to Month 18) | Month 18 (17 - 21 months postoperatively) | Absolute rotation of the TICL in treated eyes between visits (Change from Month 12 to Month 18) |
| Absolute Rotation of the TICL Between Visits (Change From Month 18 to Month 24) | Month 24 (23 - 27 months postoperatively) | Absolute rotation of the TICL in treated eyes between visits (Change from Month 18 to Month 24) |
| Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Operative Visit) | Operative Visit | Absolute rotation of the TICL in treated eyes \<5 degrees, \<10 degrees, \<20 degrees, and \<30 degrees from the intended orientation at each visit |
| Absolute Rotation of the TICL <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Day 1) | Day 1 Visit | Absolute rotation of the TICL in treated eyes \<5 degrees, \<10 degrees, \<20 degrees, and \<30 degrees from the intended orientation at each visit |
| Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Week 1 Visit) | Week 1 Visit | Absolute rotation of the TICL in treated eyes \<5 degrees, \<10 degrees, \<20 degrees, and \<30 degrees from the intended orientation at each visit |
| Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 1 Visit) | Month 1 Visit | Absolute rotation of the TICL in treated eyes \<5 degrees, \<10 degrees, \<20 degrees, and \<30 degrees from the intended orientation at each visit |
| Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 3 Visit) | Month 3 Visit | Absolute rotation of the TICL in treated eyes \<5 degrees, \<10 degrees, \<20 degrees, and \<30 degrees from the intended orientation at each visit |
| Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 6 Visit) | Month 6 Visit | Absolute rotation of the TICL in treated eyes \<5 degrees, \<10 degrees, \<20 degrees, and \<30 degrees from the intended orientation at each visit |
| Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 12 Visit) | Month 12 Visit | Absolute rotation of the TICL in treated eyes \<5 degrees, \<10 degrees, \<20 degrees, and \<30 degrees from the intended orientation at each visit |
| Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 18 Visit) | Month 18 Visit | Absolute rotation of the TICL in treated eyes \<5 degrees, \<10 degrees, \<20 degrees, and \<30 degrees from the intended orientation at each visit |
| Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 24 Visit) | Month 24 Visit | Absolute rotation of the TICL in treated eyes \<5 degrees, \<10 degrees, \<20 degrees, and \<30 degrees from the intended orientation at each visit |
| Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Operative Visit) | Operative Visit | Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Operative Visit) |
| Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Day 1 Visit) | Day 1 Visit | Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Day 1 Visit) |
| Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Week 1 Visit) | Week 1 Visit | Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Week 1 Visit) |
| Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 1 Visit) | Month 1 Visit | Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 1 Visit) |
| Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 3 Visit) | Month 3 Visit | Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 3 Visit) |
| Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 6 Visit) | Month 6 Visit | Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 6 Visit) |
| Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month12 Visit) | Month 12 Visit | Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 12 Visit) |
| Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 18 Visit) | Month 18 Visit | Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 18 Visit) |
| Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 24 Visit) | Month 24 Visit | Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 24 Visit) |
| Manifest Refraction Spherical Equivalent (MRSE) at Month 1 | Month 1 | Postoperative manifest refraction spherical equivalent (MRSE) at each visit |
| Manifest Refraction Spherical Equivalent (MRSE) at Month 3 | Month 3 | Postoperative manifest refraction spherical equivalent (MRSE) at each visit |
| Manifest Refraction Spherical Equivalent (MRSE) at Month 6 | Month 6 | Postoperative manifest refraction spherical equivalent (MRSE) at each visit |
| Manifest Refraction Spherical Equivalent (MRSE) at Month 12 | Month 12 | Postoperative manifest refraction spherical equivalent (MRSE) at each visit |
| Manifest Refraction Spherical Equivalent (MRSE) at Month 24 | Month 24 | Postoperative manifest refraction spherical equivalent (MRSE) at each visit |
| Manifest Refraction Cylinder at Month 1 | Month 1 | Postoperative manifest refraction cylinder at each visit |
| Manifest Refraction Cylinder at Month 3 | Month 3 | Postoperative manifest refraction cylinder at each visit |
| Manifest Refraction Cylinder at Month 6 | Month 6 | Postoperative manifest refraction cylinder at each visit |
| Manifest Refraction Cylinder at Month 12 | Month 12 | Postoperative manifest refraction cylinder at each visit |
| Manifest Refraction Cylinder at Month 18 | Month 18 | Postoperative manifest refraction cylinder at each visit |
| Absolute Rotation of the TICL Between Visits (Change From Day 1 to Week 1) | Week 1 (5-9 days postoperatively) | Absolute rotation of the TICL in treated eyes between visits (Change from Day 1 to Week 1) |
| Manifest Refraction Cylinder at Month 24 | Month 24 | Postoperative manifest refraction cylinder at each visit |
Countries
United States
Contacts
STUDY_DIRECTORJoanne Egamino, PhD
VP, Clinical Affairs
Participant flow
Recruitment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 125 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 32 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 81 Participants |
| Region of Enrollment United States | 125 participants |
| Sex: Female, Male Female | 77 Participants |
| Sex: Female, Male Male | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 232 | 0 / 125 |
| other Total, other adverse events | 40 / 232 | 0 / 0 |
| serious Total, serious adverse events | 29 / 232 | 2 / 125 |
Outcome results
None listed