Implantable Contact Lens for Nearsighted Astigmatism

(TICL-PAS Trial)

Recruiting at 8 trial locations

Overseen By Jennifer Lynch, MSc

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Staar Surgical Company

Disqualifiers: Diabetes, Ocular surgery, Cataract, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

125 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Research Team

Joanne Egamino, PhD

Principal Investigator

VP, Clinical Affairs

Eligibility Criteria

This trial is for individuals with moderate to high nearsighted astigmatism who have had a stable vision prescription for at least a year. Participants must be able to understand and sign the consent form, not have had previous eye surgery or cataracts, aren't pregnant or nursing, and don't have insulin-dependent diabetes or diabetic retinopathy.

Inclusion Criteria

The patient's eyes have had a stable refractive history within 0.50 D of each cylinder and a spherical equivalent of 1 year prior to implantation.

Myopia that is moderately severe to severe and has astigmatism that can be corrected with the available TICL powers.

I can come back for check-ups after my surgery.

Exclusion Criteria

You only have vision in one eye.

Pregnant or nursing women, or those who plan to become pregnant over the course of this clinical study.

I have diabetes that requires insulin or I have diabetic eye disease.

Treatment Details

Interventions

• Visian TICL

Trial Overview The study is testing the Visian Toric Implantable Collamer Lens (TICL), which is designed to correct nearsighted astigmatism. Over two years, researchers will monitor how well TICL works and its long-term effects on patients' vision.

Participant Groups

Group I: Visian TICL Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Staar Surgical Company

Lead Sponsor

Trials

6

Recruited

930+