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Clinical Trials/NCT04516772
NCT04516772CompletedNot Applicable

Post-Approval Study of the Visian Toric Implantable Collamer Lens

Staar Surgical Company8 sites in 1 country125 target enrollmentStarted: July 21, 2020Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
125
Locations
8
Primary Endpoint
Change in Axis Orientation of the TICL
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
21 Years to 45 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Visian TICL

Other

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

Intervention: Visian TICL (Device)

Outcomes

Primary Outcomes

Change in Axis Orientation of the TICL

Time Frame: 18 to 24 months postoperative

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

Secondary Outcomes

  • Manifest Refraction Cylinder at Month 18(Month 18)
  • Absolute Rotation of the TICL Between Visits (Change From Operative Visit to Day 1)(Day 1 (1-2 days postoperatively))
  • Absolute Rotation of the TICL Between Visits (Change From Day 1 to Week 1)(Week 1 (5-9 days postoperatively))
  • Absolute Rotation of the TICL Between Visits (Change From Week 1 to Month 1)(Month 1 (3-5 weeks postoperatively))
  • Absolute Rotation of the TICL Between Visits (Change From Month 1 to Month 3)(Month 3 (10-14 weeks postoperatively))
  • Absolute Rotation of the TICL Between Visits (Change From Month 3 to Month 6)(Month 6 (21 - 26 weeks postoperatively))
  • Absolute Rotation of the TICL Between Visits (Change From Month 6 to Month 12)(Month 12 (11 - 14 months postoperatively))
  • Absolute Rotation of the TICL Between Visits (Change From Month 12 to Month 18)(Month 18 (17 - 21 months postoperatively))
  • Absolute Rotation of the TICL Between Visits (Change From Month 18 to Month 24)(Month 24 (23 - 27 months postoperatively))
  • Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Operative Visit)(Operative Visit)
  • Absolute Rotation of the TICL <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Day 1)(Day 1 Visit)
  • Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Week 1 Visit)(Week 1 Visit)
  • Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 1 Visit)(Month 1 Visit)
  • Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 3 Visit)(Month 3 Visit)
  • Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 6 Visit)(Month 6 Visit)
  • Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 12 Visit)(Month 12 Visit)
  • Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 18 Visit)(Month 18 Visit)
  • Absolute Rotation <5 Degrees, <10 Degrees, <20 Degrees, and <30 Degrees From the Intended Orientation at Each Visit (Month 24 Visit)(Month 24 Visit)
  • Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Operative Visit)(Operative Visit)
  • Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Day 1 Visit)(Day 1 Visit)
  • Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Week 1 Visit)(Week 1 Visit)
  • Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 1 Visit)(Month 1 Visit)
  • Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 3 Visit)(Month 3 Visit)
  • Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 6 Visit)(Month 6 Visit)
  • Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month12 Visit)(Month 12 Visit)
  • Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 18 Visit)(Month 18 Visit)
  • Absolute Rotation of the TICL From the Intended Orientation at Each Visit (Month 24 Visit)(Month 24 Visit)
  • Manifest Refraction Spherical Equivalent (MRSE) at Month 1(Month 1)
  • Manifest Refraction Spherical Equivalent (MRSE) at Month 3(Month 3)
  • Manifest Refraction Spherical Equivalent (MRSE) at Month 6(Month 6)
  • Manifest Refraction Spherical Equivalent (MRSE) at Month 12(Month 12)
  • Manifest Refraction Spherical Equivalent (MRSE) at Month 18(Month 18)
  • Manifest Refraction Spherical Equivalent (MRSE) at Month 24(Month 24)
  • Manifest Refraction Cylinder at Month 1(Month 1)
  • Manifest Refraction Cylinder at Month 3(Month 3)
  • Manifest Refraction Cylinder at Month 6(Month 6)
  • Manifest Refraction Cylinder at Month 12(Month 12)
  • Manifest Refraction Cylinder at Month 24(Month 24)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (8)

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