Extended Depth of Focus Contact Lenses for Presbyopia

Not Applicable

Completed

• Conditions: Presbyopia

• Registration Number: NCT05495971
• Lead Sponsor: Visioneering Technologies, Inc

Brief Summary

VTI has an FDA cleared soft contact lens product. Its optical design creates an enhanced depth of focus (EDOF), which provides clear distance, intermediate, and near vision. This study is to quantify the enhanced depth of focus and visual impact.

Detailed Description

This study will develop defocus curves for Baseline best corrected spectacle refraction and then for the EDOF lens used in this study. A comparison of thge depth of focus for each condition will be made.

Study Timeline

• Study First Submitted: 2022-08-08
• Study First Submitted QC: 2022-08-08
• Study First Posted: 2022-08-10
• Study Start: 2022-09-06
• Primary Completion: 2023-05-12
• Study Completion: 2023-05-12
• Results First Submitted: 2024-06-13
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Results First Posted: 2024-12-16
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Suitable and able to wear contact lenses
• Normal best corrected vision (20/25 or better)
• Need reading add +2.00 or stronger

Exclusion Criteria

• Pre-existing ocular condition that would contraindicating lens wear

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
LogMAR Visual Acuity	4 hours	High contrast/high illumination distant (6M) logMAR vision

Trial Locations

Locations (1)

VTI; 🇺🇸 Alpharetta, Georgia, United States