Presbyopia
Conditions
Keywords
soft contact lens
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.
Interventions
DEVICENaturalVue Multifocal
EDOF
Sponsors
Visioneering Technologies, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Subjects will serve as their own control using objective baseline data.
Eligibility
Sex/Gender
ALL
Age
45 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LogMAR Visual Acuity | 4 hours | High contrast/high illumination distant (6M) logMAR vision |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Presbyopia Subject's baseline vision will be compared with vision wearing treatment product
NaturalVue Multifocal: EDOF | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Presbyopia | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 1 Participants | — |
| Age, Categorical Between 18 and 65 years | 23 Participants | — |
| Age, Continuous | 59.2 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 24 participants | — |
| Sex: Female, Male Female | 19 Participants | — |
| Sex: Female, Male Male | 5 Participants | — |
| Visual acuity | -0.07 logMAR STANDARD_DEVIATION 0.07 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
LogMAR Visual Acuity
High contrast/high illumination distant (6M) logMAR vision
Time frame: 4 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Presbyopia | LogMAR Visual Acuity | -0.07 logMAR | Standard Deviation 0.07 |