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Implantable Collamer Lens

Implantable Contact Lens for Nearsighted Astigmatism (TICL-PAS Trial)

N/A
Waitlist Available
Research Sponsored by Staar Surgical Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able and willing to return for scheduled follow-up examinations after surgery.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months after surgery
Awards & highlights

TICL-PAS Trial Summary

This trial looks at the long-term success of a type of contact lens that is surgically implanted.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks of implantable lenses can include inflammation, increased eye pressure, blurry vision or visual disturbances like glare and halos around lights.

TICL-PAS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can and will come back for check-ups after my surgery.

TICL-PAS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in axis orientation of the TICL
Secondary outcome measures
Absolute Rotation of the TICL in treated eyes
Manifest refraction spherical equivalence (MRSE) and cylinder
Ocular (adverse events) AEs

TICL-PAS Trial Design

1Treatment groups
Experimental Treatment
Group I: Visian TICLExperimental Treatment1 Intervention
STAAR Visian Toric implantable collamer lens (TICL) for the correction or reduction of myopia with astigmatism.

Find a Location

Who is running the clinical trial?

Staar Surgical CompanyLead Sponsor
5 Previous Clinical Trials
803 Total Patients Enrolled
Jon Hayashida, OD., FAAOStudy DirectorVice President, Clinical and Medical Affairs
Joanne Egamino, PhDStudy DirectorVP, Clinical Affairs
4 Previous Clinical Trials
700 Total Patients Enrolled

Media Library

Visian TICL (Implantable Collamer Lens) Clinical Trial Eligibility Overview. Trial Name: NCT04516772 — N/A
Nearsighted Astigmatism Research Study Groups: Visian TICL
Nearsighted Astigmatism Clinical Trial 2023: Visian TICL Highlights & Side Effects. Trial Name: NCT04516772 — N/A
Visian TICL (Implantable Collamer Lens) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04516772 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there currently a possibility to join this clinical investigation?

"Prospective participants for this medical trial must have astigmatism and be between the ages of 21 and 45. The study is currently looking to recruit 124 individuals."

Answered by AI

Is this experiment currently enrolling participants?

"The clinicaltrials.gov page reveals that this trial, first posted on July 21st 2020 and last edited October 24th 2022, is not presently looking for participants. However, 43 other studies are actively seeking volunteers at the moment."

Answered by AI

Is this research effort recruiting participants aged 45 or above?

"This clinical trial is targeting applicants aged 21-45 years. In addition, there are two other trials available to patients outside of this age range - one for those below 18 and another for individuals older than 65 years old."

Answered by AI

How widely dispersed is this medical trial in the given municipality?

"Nine medical sites are currently enrolling patients for this clinical trial. Omaha, Dallas and West Fargo serve as some of the main locales; yet there are 6 other locations participants can consider to minimize their travel needs if they choose to join in."

Answered by AI

Who else is applying?

What state do they live in?
Texas
South Dakota
What site did they apply to?
Key-Whitman Eye Center
Vance Thompson Vision - NE
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Email
Most responsive sites:
  1. Key-Whitman Eye Center: < 48 hours
~21 spots leftby Jan 2025