Myopic Astigmatism Clinical Trial
— TICL-PASOfficial title:
Post-Approval Study of the Visian Toric Implantable Collamer Lens
Verified date | February 2024 |
Source | Staar Surgical Company |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 124 |
Est. completion date | January 27, 2025 |
Est. primary completion date | January 27, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 45 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Solomon Eye Physicians and Surgeons/Bowie Vision Institute | Bowie | Maryland |
United States | Cleveland Eye Clinic | Brecksville | Ohio |
United States | Key-Whitman Eye Center | Dallas | Texas |
United States | Hoopes Vision/Hoopes, Durrie, Rivera Research | Draper | Utah |
United States | Aloha Laser Vision, LLC | Honolulu | Hawaii |
United States | Price Vision Group, | Indianapolis | Indiana |
United States | Vance Thompson Vision | Omaha | Nebraska |
United States | Vance Thompson Vision | W. Fargo | North Dakota |
Lead Sponsor | Collaborator |
---|---|
Staar Surgical Company |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 18 to 24 months postoperative | |
Secondary | 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 |
1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months after surgery | |
Secondary | Manifest refraction spherical equivalence (MRSE) and cylinder | MRSE and cylinder in treated eyes | 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months after surgery | |
Secondary | Ocular (adverse events) AEs | Incidence of AEs in treated eyes | Through study completion, an average of 24 months |
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---|---|---|---|
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