STAAR Visian Toric ICL Post-Approval Study (TICL-PAS)

Post-Approval Study of the Visian Toric Implantable Collamer Lens

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).

Study Overview

• Status: Completed
• Conditions: Myopic Astigmatism
• Intervention / Treatment: Device: Visian TICL

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.

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • Aloha Laser Vision, LLC
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Price Vision Group,
  • Maryland
    • Bowie, Maryland, United States, 20716
      • Solomon Eye Physicians and Surgeons/Bowie Vision Institute
  • Nebraska
    • Omaha, Nebraska, United States, 68137
      • Vance Thompson Vision
  • North Dakota
    • West Fargo, North Dakota, United States, 58078
      • Vance Thompson Vision
  • Ohio
    • Brecksville, Ohio, United States, 44141
      • Cleveland Eye Clinic
  • Texas
    • Dallas, Texas, United States, 75243
      • Key-Whitman Eye Center
  • Utah
    • Draper, Utah, United States, 84020
      • Hoopes Vision/Hoopes, Durrie, Rivera Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Visian TICL; STAAR Visian Toric implantable collamer lens (TICL) for the correction or reduction of myopia with astigmatism.	Device: Visian 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.; Other Names: Visian Toric ICL; TMICL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	18 to 24 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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)	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)	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)	Month 6 (21 - 26 weeks postoperatively)
Absolute Rotation of the TICL Between Visits (Change From Month 6 to Month 12)	Absolute rotation of the TICL in treated eyes between visits (Change from Month 6 to Month 12)	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)	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)	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	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	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	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	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	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	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	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	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	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)	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)	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)	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)	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)	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)	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)	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)	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)	Month 24 Visit
Manifest Refraction Spherical Equivalent (MRSE) at Month 1	Postoperative manifest refraction spherical equivalent (MRSE) at each visit	Month 1
Manifest Refraction Spherical Equivalent (MRSE) at Month 3	Postoperative manifest refraction spherical equivalent (MRSE) at each visit	Month 3
Manifest Refraction Spherical Equivalent (MRSE) at Month 6	Postoperative manifest refraction spherical equivalent (MRSE) at each visit	Month 6
Manifest Refraction Spherical Equivalent (MRSE) at Month 12	Postoperative manifest refraction spherical equivalent (MRSE) at each visit	Month 12
Manifest Refraction Spherical Equivalent (MRSE) at Month 18	Postoperative manifest refraction spherical equivalent (MRSE) at each visit	Month 18
Manifest Refraction Spherical Equivalent (MRSE) at Month 24	Postoperative manifest refraction spherical equivalent (MRSE) at each visit	Month 24
Manifest Refraction Cylinder at Month 1	Postoperative manifest refraction cylinder at each visit	Month 1
Manifest Refraction Cylinder at Month 3	Postoperative manifest refraction cylinder at each visit	Month 3
Manifest Refraction Cylinder at Month 6	Postoperative manifest refraction cylinder at each visit	Month 6
Manifest Refraction Cylinder at Month 12	Postoperative manifest refraction cylinder at each visit	Month 12
Manifest Refraction Cylinder at Month 18	Postoperative manifest refraction cylinder at each visit	Month 18
Manifest Refraction Cylinder at Month 24	Postoperative manifest refraction cylinder at each visit	Month 24

Collaborators and Investigators

• Sponsor: Staar Surgical Company
• Investigators: Study Director: Joanne Egamino, PhD, VP, Clinical Affairs

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2020
• Primary Completion (Actual): December 11, 2024
• Study Completion (Actual): December 11, 2024

Study Registration Dates

• First Submitted: August 10, 2020
• First Submitted That Met QC Criteria: August 13, 2020
• First Posted (Actual): August 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: astigmatism; Toric ICL; Visian; nearsightedness; phakic IOL; TICL; TMICL
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Astigmatism
• Other Study ID Numbers: CP18-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No