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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
125
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.
Aloha Laser Vision, LLC
Honolulu, Hawaii, United States
Price Vision Group,
Indianapolis, Indiana, United States
Solomon Eye Physicians and Surgeons/Bowie Vision Institute
Bowie, Maryland, United States
Vance Thompson Vision
Omaha, Nebraska, United States
Change in Axis Orientation of the TICL
Rotation of the TICL of less than or equal to five degrees in 90% of treated eyes between 18 and 24 months postoperative
Time frame: 18 to 24 months postoperative
Absolute Rotation of the TICL Between Visits (Change From Operative Visit to Day 1)
Absolute Rotation of the TICL in treated eyes between visits (change from Operative visit to Day 1)
Time frame: Day 1 (1-2 days postoperatively)
Absolute Rotation of the TICL Between Visits (Change From Day 1 to Week 1)
Absolute rotation of the TICL in treated eyes between visits (Change from Day 1 to Week 1)
Time frame: Week 1 (5-9 days postoperatively)
Absolute Rotation of the TICL Between Visits (Change From Week 1 to Month 1)
Absolute rotation of the TICL in treated eyes between visits (Change from Week 1 to Month 1)
Time frame: Month 1 (3-5 weeks postoperatively)
Absolute Rotation of the TICL Between Visits (Change From Month 1 to Month 3)
Absolute rotation of the TICL in treated eyes between visits (Change from Month 1 to Month 3)
Time frame: Month 3 (10-14 weeks postoperatively)
Absolute Rotation of the TICL Between Visits (Change From Month 3 to Month 6)
Absolute rotation of the TICL in treated eyes between visits (Change from Month 3 to Month 6)
Time frame: Month 6 (21 - 26 weeks postoperatively)
Absolute Rotation of the TICL Between Visits (Change From Month 6 to Month 12)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Vance Thompson Vision
West Fargo, North Dakota, United States
Cleveland Eye Clinic
Brecksville, Ohio, United States
Key-Whitman Eye Center
Dallas, Texas, United States
Hoopes Vision/Hoopes, Durrie, Rivera Research
Draper, Utah, United States
Absolute rotation of the TICL in treated eyes between visits (Change from Month 6 to Month 12)
Time frame: Month 12 (11 - 14 months postoperatively)
Absolute Rotation of the TICL Between Visits (Change From Month 12 to Month 18)
Absolute rotation of the TICL in treated eyes between visits (Change from Month 12 to Month 18)
Time frame: Month 18 (17 - 21 months postoperatively)
Absolute Rotation of the TICL Between Visits (Change From Month 18 to Month 24)
Absolute rotation of the TICL in treated eyes between visits (Change from Month 18 to Month 24)
Time frame: Month 24 (23 - 27 months postoperatively)
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each 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
Time frame: Operative Visit
Absolute Rotation of the TICL <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Day 1)
Absolute rotation of the TICL in treated eyes \<5 degrees, \<10 degrees, \<20 degrees, and \<30 degrees from the intended orientation at each visit
Time frame: Day 1 Visit
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each 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
Time frame: Week 1 Visit
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each 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
Time frame: Month 1 Visit
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each 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
Time frame: Month 3 Visit
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each 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
Time frame: Month 6 Visit
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each 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
Time frame: Month 12 Visit
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each 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
Time frame: Month 18 Visit
Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each 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
Time frame: Month 24 Visit
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Operative Visit)
Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Operative Visit)
Time frame: Operative Visit
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Day 1 Visit)
Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Day 1 Visit)
Time frame: Day 1 Visit
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Week 1 Visit)
Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Week 1 Visit)
Time frame: Week 1 Visit
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 1 Visit)
Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 1 Visit)
Time frame: Month 1 Visit
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 3 Visit)
Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 3 Visit)
Time frame: Month 3 Visit
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 6 Visit)
Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 6 Visit)
Time frame: Month 6 Visit
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month12 Visit)
Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 12 Visit)
Time frame: Month 12 Visit
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 18 Visit)
Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 18 Visit)
Time frame: Month 18 Visit
Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 24 Visit)
Absolute Rotation of the TICL in treated eyes from the intended orientation at each visit (Month 24 Visit)
Time frame: Month 24 Visit
Manifest Refraction Spherical Equivalent (MRSE) at Month 1
Postoperative manifest refraction spherical equivalent (MRSE) at each visit
Time frame: Month 1
Manifest Refraction Spherical Equivalent (MRSE) at Month 3
Postoperative manifest refraction spherical equivalent (MRSE) at each visit
Time frame: Month 3
Manifest Refraction Spherical Equivalent (MRSE) at Month 6
Postoperative manifest refraction spherical equivalent (MRSE) at each visit
Time frame: Month 6
Manifest Refraction Spherical Equivalent (MRSE) at Month 12
Postoperative manifest refraction spherical equivalent (MRSE) at each visit
Time frame: Month 12
Manifest Refraction Spherical Equivalent (MRSE) at Month 18
Postoperative manifest refraction spherical equivalent (MRSE) at each visit
Time frame: Month 18
Manifest Refraction Spherical Equivalent (MRSE) at Month 24
Postoperative manifest refraction spherical equivalent (MRSE) at each visit
Time frame: Month 24
Manifest Refraction Cylinder at Month 1
Postoperative manifest refraction cylinder at each visit
Time frame: Month 1
Manifest Refraction Cylinder at Month 3
Postoperative manifest refraction cylinder at each visit
Time frame: Month 3
Manifest Refraction Cylinder at Month 6
Postoperative manifest refraction cylinder at each visit
Time frame: Month 6
Manifest Refraction Cylinder at Month 12
Postoperative manifest refraction cylinder at each visit
Time frame: Month 12
Manifest Refraction Cylinder at Month 18
Postoperative manifest refraction cylinder at each visit
Time frame: Month 18
Manifest Refraction Cylinder at Month 24
Postoperative manifest refraction cylinder at each visit
Time frame: Month 24