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

STAAR Surgical

Status: Active, not recruiting

Conditions: Myopic Astigmatism

Treatments: Device: Visian TICL

Study type: Interventional

Funder types: Industry

Identifiers

NCT04516772

CP18-02

Details and patient eligibility

About

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).

Full 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.

Enrollment: 124 estimated patients

Sex: All

Ages: 21 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

124 participants in 1 patient group

Visian TICL

Other group

Description:

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

Treatment:

Device: Visian TICL