Extended Depth of Focus Contact Lenses for Presbyopia
December 12, 2024 updated by: Visioneering Technologies, Inc
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Georgia
-
Alpharetta, Georgia, United States, 30009
- VTI
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Presbyopia
Subject's baseline vision will be compared with vision wearing treatment product
|
EDOF
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
LogMAR Visual Acuity
Time Frame: 4 hours
|
High contrast/high illumination distant (6M) logMAR vision
|
4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Douglas P. Benoit, OD, Visioneering Technologies, Inc
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 6, 2022
Primary Completion (Actual)
May 12, 2023
Study Completion (Actual)
May 12, 2023
Study Registration Dates
First Submitted
August 8, 2022
First Submitted That Met QC Criteria
August 8, 2022
First Posted (Actual)
August 10, 2022
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 12, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VTI-2206
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.