Implantable Contact Lens for Nearsighted Astigmatism

(TICL-PAS Trial)

No longer recruiting at 9 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: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new implantable contact lens designed to help individuals with nearsighted astigmatism, a condition where vision blurs due to the eye's shape. The goal is to evaluate the effectiveness of these lenses over two years. Suitable participants have moderate to high nearsightedness with astigmatism and have maintained stable vision for at least a year. The trial involves implanting these special lenses and attending follow-up exams.

As an unphased trial, this study provides a unique opportunity to contribute to innovative vision correction research.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Visian TICL is safe for correcting nearsighted astigmatism?

Research has shown that the Visian Toric Implantable Collamer Lens (TICL) is generally safe for treating nearsightedness with astigmatism. One study found the lens both safe and effective for this eye condition. Other research indicates that it can improve vision for up to two years after implantation.

However, patients with very high levels of nearsightedness and astigmatism experienced less effective results. Despite this, the FDA has approved the lens for correcting nearsightedness with astigmatism, indicating a strong safety record. Overall, most patients tolerate the Visian TICL well, with safety data supporting its use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Visian TICL is unique because it offers a new way to correct nearsighted astigmatism by using an implantable collamer lens. Unlike standard treatments like glasses, contact lenses, or laser surgery, this lens is implanted inside the eye, providing a more permanent solution. Researchers are excited about this treatment because it targets both myopia and astigmatism in one procedure, potentially improving vision without the need for ongoing adjustments or replacements.

What evidence suggests that the Visian TICL is effective for nearsighted astigmatism?

Research has shown that the Visian Toric Implantable Collamer Lens (TICL), which participants in this trial will receive, is safe and effective for treating myopic astigmatism, a condition characterized by nearsightedness with an irregularly shaped cornea. Early results suggest that this lens can significantly improve vision for individuals with this condition. However, those with very high levels of nearsightedness might not experience as much improvement. Overall, the Visian TICL appears promising in reducing vision problems caused by myopic astigmatism. ^{1 2 3 4 6}

Who Is on the Research Team?

Joanne Egamino, PhD

Principal Investigator

VP, Clinical Affairs

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Visian Toric Implantable Collamer Lens (ICL) for the correction or reduction of myopia with astigmatism

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of TICL rotation and ocular adverse events

24 months

Multiple visits at 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8274236/

Toric Implantable Collamer Lens for the Treatment of Myopic ... This initial single-site experience finds Toric ICL implantation for myopic astigmatism to be safe and effective.

2. staar.com staar.com/file/FINAL-TMICL-PIB-Rev-3.pdf

Visian® Toric ICL ™ (Implantable Collamer® Lens) Patients with higher amounts of nearsightedness with astigmatism had worse results. The Visian Toric ICL was less effective in correcting nearsightedness and.

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf3/P030016S001c.pdf

Visian® Toric ICL ™ (Implantable Collamer® Lens) 1. Patients with higher amounts of nearsightedness with astigmatism had worse results. The Visian Toric ICL was less effective in correcting nearsightedness and.

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf3/P030016S035B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) The current supplement was submitted to expand the indication for theVisian Implantable. Collamer Lens for the treatment of myopia with and ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34262249/

Toric Implantable Collamer Lens for the Treatment of ... This initial single-site experience finds Toric ICL implantation for myopic astigmatism to be safe and effective.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4383407/

Safety and Visual Outcome of Visian Toric ICL Implantation ... Visian toric ICL implantation following CXL is an effective option for improving visual acuity in patients with keratoconus up to 2 years.