NCT05518344

Study of Viziatek ISL™ Refractive Phakic Intra Sulcus Lens for Refraction Adjustment in Blind Volunteers

Clinical Investigation of "Viziatek ISL™ Refractive Phakic Intra Sulcus Lens" for Refraction Adjustment in Blind Volunteers

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Hanita Lenses · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a clinical investigation. A total of up to 5 subjects, but not less than 3 at one investigational site will undergo insertion of the ISL in one eye and will be followed through 6 months postoperative. Subjects from the United States will not be enrolled in this study.

Detailed description

The Viziatek ISL is intended to improve myopic vision and decrease dependence on glasses in myopic adults who don't have an irregular astigmatic cornea (as evaluated by topography), who require correction of -3.50 D to -23 D, who have BCVA - Distance between 20/20 to 20/30 and with no more than 5 D of the refractive cylinder, and who have stable MRSE within 0.50 D over the past 12 months.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	Viziatek ISL™ (hereinafter referred to as the "ISL") implanted in blind eye.	Viziatek ISL™ (hereinafter referred to as the "ISL") implanted in blind eye.

Timeline

• Start date: 2020-06-04
• Primary completion: 2022-03-16
• Completion: 2022-03-16
• First posted: 2022-08-26
• Last updated: 2022-08-26

Locations

1 site across 1 country: Latvia