STAAR Visian Toric ICL Post-Approval Study

NCT04516772 | Completed Results FDA Device

• 1 other identifier: CP18-02
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 8

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).

Conditions

Myopic Astigmatism

Keywords

nearsightedness; phakic IOL; Toric ICL; TICL; TMICL; Visian; astigmatism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (38)

• 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 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)

  Month 1 (3-5 weeks postoperatively)

• 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 Between Visits (Change From Month 3 to Month 6)

  Month 6 (21 - 26 weeks postoperatively)

Study Arms (1)

Visian TICL

OTHER

STAAR Visian Toric implantable collamer lens (TICL) for the correction or reduction of myopia with astigmatism.

Device: Visian TICL

Interventions

Visian TICL DEVICE

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.

Also known as: Visian Toric ICL, TMICL

Visian TICL

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Staar Surgical Company: lead

Study Sites (8)

Aloha Laser Vision, LLC

Honolulu, Hawaii, 96814, United States

Location

Price Vision Group,

Indianapolis, Indiana, 46260, United States

Location

Solomon Eye Physicians and Surgeons/Bowie Vision Institute

Bowie, Maryland, 20716, United States

Location

Vance Thompson Vision

Omaha, Nebraska, 68137, United States

Location

Vance Thompson Vision

West Fargo, North Dakota, 58078, United States

Location

Cleveland Eye Clinic

Brecksville, Ohio, 44141, United States

Location

Key-Whitman Eye Center

Dallas, Texas, 75243, United States

Location

Hoopes Vision/Hoopes, Durrie, Rivera Research

Draper, Utah, 84020, United States

Location

MeSH Terms

Conditions

Astigmatism; Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Joanne Egamino
• Organization: STAAR Surgical

jegamino@staar.com

626-303-7902

Study Officials

• Joanne Egamino, PhD

  VP, Clinical Affairs

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 18, 2020
• Study Start: July 21, 2020
• Primary Completion: December 11, 2024
• Study Completion: December 11, 2024
• Last Updated: March 13, 2026
• Results First Posted: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)