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

S

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

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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