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Completed

NCT Number: NCT04516772

STAAR Visian Toric ICL Post-Approval Study

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).

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Key information

Conditions

Myopic Astigmatism Astigmatism Eye Diseases Myopia Refractive Errors

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aloha Laser Vision, LLC, Honolulu, Hawaii, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Visian Toric ICL, TMICL

Primary outcomes

  1. Change in Axis Orientation of the TICL

    Time frame: 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 outcomes

  1. Absolute Rotation of the TICL Between Visits (Change From Operative Visit to Day 1)

    Time frame: Day 1 (1-2 days postoperatively)

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

  2. Absolute Rotation of the TICL Between Visits (Change From Day 1 to Week 1)

    Time frame: Week 1 (5-9 days postoperatively)

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

  3. Absolute Rotation of the TICL Between Visits (Change From Week 1 to Month 1)

    Time frame: Month 1 (3-5 weeks postoperatively)

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

  4. Absolute Rotation of the TICL Between Visits (Change From Month 1 to Month 3)

    Time frame: Month 3 (10-14 weeks postoperatively)

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

  5. Absolute Rotation of the TICL Between Visits (Change From Month 3 to Month 6)

    Time frame: Month 6 (21 - 26 weeks postoperatively)

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

  6. Absolute Rotation of the TICL Between Visits (Change From Month 6 to Month 12)

    Time frame: Month 12 (11 - 14 months postoperatively)

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

  7. Absolute Rotation of the TICL Between Visits (Change From Month 12 to Month 18)

    Time frame: Month 18 (17 - 21 months postoperatively)

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

  8. Absolute Rotation of the TICL Between Visits (Change From Month 18 to Month 24)

    Time frame: Month 24 (23 - 27 months postoperatively)

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

  9. Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Operative Visit)

    Time frame: 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

  10. Absolute Rotation of the TICL <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Day 1)

    Time frame: 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

  11. Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Week 1 Visit)

    Time frame: 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

  12. Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 1 Visit)

    Time frame: 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

  13. Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 3 Visit)

    Time frame: 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

  14. Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 6 Visit)

    Time frame: 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

  15. Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 12 Visit)

    Time frame: 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

  16. Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 18 Visit)

    Time frame: 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

  17. Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 24 Visit)

    Time frame: 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

  18. Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Operative Visit)

    Time frame: Operative Visit

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

  19. Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Day 1 Visit)

    Time frame: Day 1 Visit

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

  20. Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Week 1 Visit)

    Time frame: Week 1 Visit

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

  21. Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 1 Visit)

    Time frame: Month 1 Visit

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

  22. Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 3 Visit)

    Time frame: Month 3 Visit

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

  23. Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 6 Visit)

    Time frame: Month 6 Visit

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

  24. Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month12 Visit)

    Time frame: Month 12 Visit

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

  25. Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 18 Visit)

    Time frame: Month 18 Visit

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

  26. Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 24 Visit)

    Time frame: Month 24 Visit

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

  27. Manifest Refraction Spherical Equivalent (MRSE) at Month 1

    Time frame: Month 1

    Postoperative manifest refraction spherical equivalent (MRSE) at each visit

  28. Manifest Refraction Spherical Equivalent (MRSE) at Month 3

    Time frame: Month 3

    Postoperative manifest refraction spherical equivalent (MRSE) at each visit

  29. Manifest Refraction Spherical Equivalent (MRSE) at Month 6

    Time frame: Month 6

    Postoperative manifest refraction spherical equivalent (MRSE) at each visit

  30. Manifest Refraction Spherical Equivalent (MRSE) at Month 12

    Time frame: Month 12

    Postoperative manifest refraction spherical equivalent (MRSE) at each visit

  31. Manifest Refraction Spherical Equivalent (MRSE) at Month 18

    Time frame: Month 18

    Postoperative manifest refraction spherical equivalent (MRSE) at each visit

  32. Manifest Refraction Spherical Equivalent (MRSE) at Month 24

    Time frame: Month 24

    Postoperative manifest refraction spherical equivalent (MRSE) at each visit

  33. Manifest Refraction Cylinder at Month 1

    Time frame: Month 1

    Postoperative manifest refraction cylinder at each visit

  34. Manifest Refraction Cylinder at Month 3

    Time frame: Month 3

    Postoperative manifest refraction cylinder at each visit

  35. Manifest Refraction Cylinder at Month 6

    Time frame: Month 6

    Postoperative manifest refraction cylinder at each visit

  36. Manifest Refraction Cylinder at Month 12

    Time frame: Month 12

    Postoperative manifest refraction cylinder at each visit

  37. Manifest Refraction Cylinder at Month 18

    Time frame: Month 18

    Postoperative manifest refraction cylinder at each visit

  38. Manifest Refraction Cylinder at Month 24

    Time frame: Month 24

    Postoperative manifest refraction cylinder at each visit

Sponsors and collaborators

Lead sponsor

Staar Surgical Company

Industry

Registry information

Official study title

Post-Approval Study of the Visian Toric Implantable Collamer Lens

Acronym: TICL-PAS

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 18, 2020
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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