Accommodation, Computer Vision Syndrome
Conditions
Keywords
computer vision syndrome, contact lens
Brief summary
The proposed study will address this gap by comparing the efficacy of two novel stenfilcon A contact lens designs in alleviating accommodative burden associated with digital device usage. The primary outcomes are measured with the following: * Computer vision syndrome questionnaire * Binocular logMar (H/Lo contrast) visual acuity at 6M and 40cm. * Binocular range of clear vision * Subjective assessment of accommodation * Objective assessment of accommodation Subjects will be randomly assigned to wear one contact lens design for 5 days. Then crossed over tot he opposing design after a three day washout period, and again asked to wear the lens for 5 days.
Detailed description
Digital device use is associated with symptoms known as Computer Vision Syndrome (CVS), which may include eye strain, dryness, blurred vision, and headaches. Contact lens wearers may experience increased symptoms during prolonged near-focus activities. New contact lens designs have been developed to help reduce accommodative stress during digital device use; however, clinical evidence comparing their performance remains limited. This randomized, double-masked, crossover study will compare two daily disposable stenfilcon A contact lenses. Each participant will wear both lens designs for five days each, separated by a three-day washout. Primary outcomes include subjective symptoms, visual acuity, range of clear vision, subjective accommodative performance, and objective accommodative response. The study is designed to provide evidence regarding the relative performance of the two lens designs in reducing visual discomfort and accommodative burden during digital device use.
Interventions
DEVICEStenfilcon A contact lens designs with and without Digital Boost technology that incorporate a 0.3D add power into the lens
The MyDay stenfilcon A contact lens is a spherical lens. The MyDay Energys stenfilcon A contact lens has Digital Boost technology that incorporate 0.3D ADD power into the lens.
Sponsors
Southern College of Optometry
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Score of \>6 on CVS-Q * Male or female * Age \>18 years to 35 years of age * Experienced, well-adapted contact lens wearers * Spherical equivalent refractive error between ±6.00DS with astigmatism \< -0.75D * Normal stereopsis and binocular status
Exclusion criteria
* Monovision * History of refractive surgery * Binocular vision abnormalities * Current ocular or systemic disease that may affect the eye * Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Computer vision syndrome questionnaire (CVS-Q) | Collected at baseline, visit 2 (1-2 weeks), and visit 3 (3-4 weeks) | Computer vision syndrome questionnaire (CVS-Q) is a reliable and valid tool for measuring visual symptoms related to computer use in the workplace. It asks subjects to rate the frequency (never, occasionally, often) and intensity (moderate, intense) of 16 visual symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binocular logMar (H/Lo contrast) visual acuity at 6M and 40cm | Collected at baseline, visit 2 (1-2 weeks), and visit 3 (3-4 weeks) | Binocular logMar (H/Lo contrast) visual acuity at 6M and 40cm. The M\&S Technologies Smart System II (M\&S Technologies, Niles, IL) has been shown to be comparable to ETDRS and Pelli Robson charts. Computer tests have been shown to a reliable, capable way of assessing vision. |
| Subjective assessment of accommodation | Collected at baseline, visit 2 (1-2 weeks), and visit 3 (3-4 weeks) | Subjective assessment of accommodation is assessed by plotting a binocular defocus curve over-refraction at 6M (-3.00 to +3.00D in 0.50D steps) in phoropter while wearing contact lenses. Room luminance will be controlled and subjects will view optotypes through a standardized 4 mm aperture to reduce confounding effects on retinal defocus. Lenses will be presented in a randomized order. |
| Objective assessment of accommodation | Collected at baseline, visit 2 (1-2 weeks), and visit 3 (3-4 weeks) | Objective assessment of accommodation Multiple studies support quantitative and qualitative changes in accommodation may be associated with asthenopia. The Grand Seiko WR 5500 (AIT, Bensenville, IL) has been shown to be capable of reliably measuring objective accommodation. A near target is viewed through increasing powered negative trial lenses (0 diopter to -4.00 diopter in 1.00D steps) and the response measured with the WR-5500K. |
Countries
United States
Outcome results
None listed