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

Myopia Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05518344
Study type Interventional
Source Hanita Lenses
Contact
Status Terminated
Phase N/A
Start date June 4, 2020
Completion date March 16, 2022
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