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

Primary Purpose

Myopic Astigmatism

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Visian TICL
Sponsored by
Staar Surgical Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopic Astigmatism focused on measuring nearsightedness, phakic IOL, Toric ICL, TICL, TMICL, Visian, astigmatism

Eligibility Criteria

21 Years - 45 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Aloha Laser Vision, LLC
  • Price Vision Group,
  • Solomon Eye Physicians and Surgeons/Bowie Vision Institute
  • Vance Thompson Vision
  • Vance Thompson Vision
  • Cleveland Eye Clinic
  • Key-Whitman Eye Center
  • Hoopes Vision/Hoopes, Durrie, Rivera Research

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Visian TICL

Arm Description

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

Outcomes

Primary Outcome Measures

Change in axis orientation of the TICL
Rotation of the TICL of less than or equal to five degrees in 90% of treated eyes between 18 and 24 months postoperative

Secondary Outcome Measures

Absolute Rotation of the TICL in treated eyes
Absolute rotation of the TICL between visits Absolute rotation of the TICL <5 degrees, <10 degrees, <20 degrees, and <30 degrees from intended orientation Absolute rotation of the TICL at each visit
Manifest refraction spherical equivalence (MRSE) and cylinder
MRSE and cylinder in treated eyes
Ocular (adverse events) AEs
Incidence of AEs in treated eyes

Full Information

First Posted
August 10, 2020
Last Updated
March 1, 2023
Sponsor
Staar Surgical Company
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1. Study Identification

Unique Protocol Identification Number
NCT04516772
Brief Title
STAAR Visian Toric ICL Post-Approval Study
Acronym
TICL-PAS
Official Title
Post-Approval Study of the Visian Toric Implantable Collamer Lens
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 21, 2020 (Actual)
Primary Completion Date
January 27, 2025 (Anticipated)
Study Completion Date
January 27, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Staar Surgical Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopic Astigmatism
Keywords
nearsightedness, phakic IOL, Toric ICL, TICL, TMICL, Visian, astigmatism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All enrolled subjects will undergo phakic eye surgery to have the STAAR Visian Toric Implantable Collamer Lens (TICL) implanted in one or both eligible eyes.
Masking
None (Open Label)
Allocation
N/A
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Visian TICL
Arm Type
Other
Arm Description
STAAR Visian Toric implantable collamer lens (TICL) for the correction or reduction of myopia with astigmatism.
Intervention Type
Device
Intervention Name(s)
Visian TICL
Other Intervention Name(s)
Visian Toric ICL, TMICL
Intervention Description
The Visian TICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
Primary Outcome Measure Information:
Title
Change in axis orientation of the TICL
Description
Rotation of the TICL of less than or equal to five degrees in 90% of treated eyes between 18 and 24 months postoperative
Time Frame
18 to 24 months postoperative
Secondary Outcome Measure Information:
Title
Absolute Rotation of the TICL in treated eyes
Description
Absolute rotation of the TICL between visits Absolute rotation of the TICL <5 degrees, <10 degrees, <20 degrees, and <30 degrees from intended orientation Absolute rotation of the TICL at each visit
Time Frame
1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months after surgery
Title
Manifest refraction spherical equivalence (MRSE) and cylinder
Description
MRSE and cylinder in treated eyes
Time Frame
1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months after surgery
Title
Ocular (adverse events) AEs
Description
Incidence of AEs in treated eyes
Time Frame
Through study completion, an average of 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanne Egamino, PhD
Organizational Affiliation
VP, Clinical Affairs
Official's Role
Study Director
Facility Information:
Facility Name
Aloha Laser Vision, LLC
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Price Vision Group,
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Solomon Eye Physicians and Surgeons/Bowie Vision Institute
City
Bowie
State/Province
Maryland
ZIP/Postal Code
20716
Country
United States
Facility Name
Vance Thompson Vision
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68137
Country
United States
Facility Name
Vance Thompson Vision
City
W. Fargo
State/Province
North Dakota
ZIP/Postal Code
58078
Country
United States
Facility Name
Cleveland Eye Clinic
City
Brecksville
State/Province
Ohio
ZIP/Postal Code
44141
Country
United States
Facility Name
Key-Whitman Eye Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
Hoopes Vision/Hoopes, Durrie, Rivera Research
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

STAAR Visian Toric ICL Post-Approval Study

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