STAAR Visian Toric ICL Post-Approval Study

Not Applicable

Completed

• Conditions: Myopic Astigmatism
• Interventions: Device: Visian TICL

• Registration Number: NCT04516772
• Lead Sponsor: Staar Surgical Company

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.

Study Timeline

• Study Start: 2020-07-21
• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-08-13
• Study First Posted: 2020-08-18
• Primary Completion: 2024-12-11
• Study Completion: 2024-12-11
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Absolute Rotation of the TICL in treated eyes	1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months after surgery	* Absolute rotation of the TICL between visits; * Absolute rotation of the TICL \<5 degrees, \<10 degrees, \<20 degrees, and \<30 degrees from intended orientation; * Absolute rotation of the TICL at each visit
Manifest refraction spherical equivalence (MRSE) and cylinder	1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months after surgery	MRSE and cylinder in treated eyes
Ocular (adverse events) AEs	Through study completion, an average of 24 months	Incidence of AEs in treated eyes

Trial Locations

Locations (7)

Solomon Eye Physicians and Surgeons/Bowie Vision Institute; 🇺🇸 Bowie, Maryland, United States

Hoopes Vision/Hoopes, Durrie, Rivera Research; 🇺🇸 Draper, Utah, United States

Vance Thompson Vision; 🇺🇸 W. Fargo, North Dakota, United States

Aloha Laser Vision, LLC; 🇺🇸 Honolulu, Hawaii, United States

Price Vision Group,; 🇺🇸 Indianapolis, Indiana, United States

Cleveland Eye Clinic; 🇺🇸 Brecksville, Ohio, United States

Key-Whitman Eye Center; 🇺🇸 Dallas, Texas, United States