Extended Depth of Focus Contact Lenses for Presbyopia
Sponsor
Visioneering Technologies, Inc (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05495971
Collaborator
(none)
50
1
1
28
1.8
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Subjects will serve as their own control using objective baseline data.Subjects will serve as their own control using objective baseline data.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Extended Depth of Focus Contact Lenses for Presbyopia
Anticipated Study Start Date
:
Aug 1, 2022
Anticipated Primary Completion Date
:
Dec 1, 2024
Anticipated Study Completion Date
:
Dec 1, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Presbyopia Subject's baseline vision will be compared with vision wearing treatment product |
Device: NaturalVue Multifocal
EDOF
|
Outcome Measures
Primary Outcome Measures
- LogMAR Visual Acuity [4 hours]
Vision at different viewing conditions
Eligibility Criteria
Criteria
Ages Eligible for Study:
45 Years
to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VTI | Alpharetta | Georgia | United States | 30009 |
Sponsors and Collaborators
- Visioneering Technologies, Inc
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Visioneering Technologies, Inc
ClinicalTrials.gov Identifier:
NCT05495971
Other Study ID Numbers:
- VTI-2206
First Posted:
Aug 10, 2022
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Visioneering Technologies, Inc
Additional relevant MeSH terms: