Clinical trial NCT04516772: STAAR Visian Toric ICL Post-Approval Study
Official title: Post-Approval Study of the Visian Toric Implantable Collamer Lens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopic Astigmatism
Keywords: nearsightedness
phakic IOL
Toric ICL
TICL
TMICL
Visian
astigmatism
Lead sponsor: Staar Surgical Company
Sponsor class: INDUSTRY
First posted: 2020-08-18
Enrollment: 125
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in axis orientation of the TICL
timeFrame: 18 to 24 months postoperative
Secondary outcomes:
measure: Absolute Rotation of the TICL in treated eyes
timeFrame: 1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months after surgery
measure: Manifest refraction spherical equivalence (MRSE) and cylinder
timeFrame: 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months after surgery
measure: Ocular (adverse events) AEs
timeFrame: Through study completion, an average of 24 months
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Aloha Laser Vision, LLC
state: Hawaii
city: Indianapolis
country: United States
facility: Price Vision Group,
state: Indiana
city: Bowie
country: United States
facility: Solomon Eye Physicians and Surgeons/Bowie Vision Institute
state: Maryland
city: Omaha
country: United States
facility: Vance Thompson Vision
state: Nebraska
city: W. Fargo
country: United States
facility: Vance Thompson Vision
state: North Dakota
city: Brecksville
country: United States
facility: Cleveland Eye Clinic
state: Ohio
city: Dallas
country: United States
facility: Key-Whitman Eye Center
state: Texas
city: Draper
country: United States
facility: Hoopes Vision/Hoopes, Durrie, Rivera Research
state: Utah
Study officials:
affiliation: VP, Clinical Affairs
name: Joanne Egamino, PhD
role: STUDY_DIRECTOR
References: