STAAR Visian Toric ICL Post-Approval Study

Myopic Astigmatism Clinical Trial

— TICL-PAS  

Official title:

Post-Approval Study of the Visian Toric Implantable Collamer Lens

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04516772
• Other study ID #: CP18-02
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 21, 2020
• Est. completion date: January 27, 2025

Study information

• Verified date: February 2024
• Source: Staar Surgical Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 124
• Est. completion date: January 27, 2025
• Est. primary completion date: January 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Astigmatism
• Myopic Astigmatism

Intervention

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.

Locations

Country	Name	City	State
United States	Solomon Eye Physicians and Surgeons/Bowie Vision Institute	Bowie	Maryland
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	Aloha Laser Vision, LLC	Honolulu	Hawaii
United States	Price Vision Group,	Indianapolis	Indiana
United States	Vance Thompson Vision	Omaha	Nebraska
United States	Vance Thompson Vision	W. Fargo	North Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Staar Surgical Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Absolute Rotation of the TICL in treated eyes	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	1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months after surgery
Secondary	Manifest refraction spherical equivalence (MRSE) and cylinder	MRSE and cylinder in treated eyes	1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months after surgery
Secondary	Ocular (adverse events) AEs	Incidence of AEs in treated eyes	Through study completion, an average of 24 months