N/A
N=16
Evaluating Contact Lens Optics
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT05028790 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Visual Performance — 0.23; 0.38 logMAR
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Single vision contact lens (Device); Multifocal contact lens (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- David A Berntsen, OD PhD
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Performance |
0.23; 0.38 | — |
| SECONDARY Spherical Equivalent Refractive Error On-axis |
0.61; 0.17 | — |
| SECONDARY Spherical Equivalent Refractive Error at 30 Degrees Temporal Retina |
0.68; -1.20 | — |
| SECONDARY Spherical Equivalent Refractive Error at 20 Degrees Temporal Retina |
0.52; -1.30 | — |
| SECONDARY Spherical Equivalent Refractive Error at 20 Degrees Nasal Retina |
0.67; -0.17 | — |
| SECONDARY Spherical Equivalent Refractive Error at 30 Degrees Nasal Retina |
0.77; -0.75 | — |
Summary
This study will evaluate changes in refractive error and visual performance between a single vision soft contact lens and multifocal soft contact lens
Eligibility Criteria
Inclusion Criteria
- Able to read and understand the informed consent document
- 18 to 39 years of age (inclusive)
- Best corrected visual acuity of 20/25 or better in the right eye
- Refractive error from -1.00D to -6.00D with astigmatism less than or equal to -1.00D in the right eye (corneal plane)
Exclusion Criteria
- Any ocular or systemic conditions affecting vision, refraction, or the ability to wear a soft contact lens
- History of ocular trauma or surgery causing abnormal or distorted vision
- Current Rigid Gas Permeable (RGP) contact lens wearers
- Unwilling to have contact lens fit photographed
- Pregnant and/or lactating females, by self-report
Data sourced from ClinicalTrials.gov (NCT05028790). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.