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OpenTrials
Completed

NCT Number: NCT02921087

Connecting Contact Lenses and Digital Technology

This study seeks to address whether or not different types of daily disposable soft contact lenses may be a beneficial option for patients complaining of eye strain and visual discomfort while using digital devices.

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Key information

Conditions

Asthenopia Central Nervous System Diseases Contact Lenses Convergence, Excess Cranial Nerve Diseases Eye Diseases Nervous System Diseases Ocular Accommodation Ocular Motility Disorders

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SUNY College of Optometry

New York, 10036, United States

About this study

This was a prospective, single site, randomized, double-masked, crossover pilot study. Subjects were randomized to begin with either multifocal or single vision distance contact lenses. The lenses used in this study were the 1-Day Acuvue (AV) Moist spherical single-vision soft contact lenses (SSCL) in the 8.5 base curve and the 1-Day AV Moist Multifocal (MFSCL) in the low ADD (etafilcon A, 58% water content). The preferred viewing distance on digital devices for a similar age group to our study was 63 cm which would require a near ADD of +1.59D. A low addition (ADD) yielding up to +1.25D was selected to provide an intermediate near addition without compromising distance vision as much as would be expected with higher add powers. The multifocal lens utilizes an aspheric center-near design. Subjects wore the lenses on a daily wear, daily disposable schedule. Following one week (± 2 days) of lens wear, subjects were evaluated and the alternate lenses dispensed. Adverse events were collected and assessed at each study visit.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 to 35 years of age
  • Spectacle prescription of -0.75 to -6.00 D sphere with no more than 0.75 diopters of refractive cylinder
  • Current single-vision soft contact lens wearer
  • Monocular acuity of 20/25 or better in each eye (Snellen)
  • Self-reported minimum of 6 hours a day on digital devices
  • Self-reported complaint of eyestrain on digital devices
  • No ocular pathology and/or history of eye surgery
  • No history of strabismus or strabismus surgery
  • No gas permeable lens wear for at least 3 months
  • Subjects may not be optometrists, opticians or optometry students

Exclusion criteria

  • Corneal staining, blepharitis and/or Meibomian Gland Dysfunction (MGD) worse than Grade 2 using the Efron Grading Scale
  • Negative Relative Accommodation (NRA) less than +1.50 D
  • Exophoria at near > 6 prism diopters10
  • Vertical phoria > 1 prism diopter
  • Presence of tropia
  • Response of 3 or higher on question 2b of the Contact Lens Dry Eye Questionnaire- 8 (CLDEQ-8)
  • Unacceptable contact lens fit (i.e. substantially decentered, excessive movement)

Treatment and study plan

Test Daily Disposable Soft Contact Lenses

Device

Worn daily for 7 +/- 2 days

Control Daily Disposable Soft Contact Lenses

Device

Worn daily for 7 +/- 2 days

Primary outcomes

  1. Subjective Symptom Improvement

    Time frame: Baseline and after 1 week of wearing each lens.

    The primary outcome measure was change in average score on a ten question Visual Comfort Survey using a Visual Analogue Scale (VAS) from baseline to day 7 in multifocal contact lenses and single vision contact lenses. The Visual Analogue Scale ranges from 0-100 (100 being the worst symptoms) for each of the ten questions. The maximum total score is 1000, the minimum total score is 0 (no symptoms).

Secondary outcomes

  1. Lens Preference

    Time frame: 2 weeks

    Based on two alternative forced choice method

  2. Lag of Accommodation in Study Lenses

    Time frame: 1 week

    Accommodative response was measured by having subjects switch the right lens to a spherical lens in the appropriate power. This was done for all subjects regardless of which lens they were randomized to, to maintain masking. Subjects wore an infrared filter over the right eye for occlusion and to ensure that they were fixating with the left eye (which was still wearing the lens they were randomized to). This filter allowed for measurements to be taken with the WAM-5500 open field autorefractor in front of the right eye. This method assumes a symmetrical accommodative response between eyes. Since accommodative response was measured monocularly, this eliminated any convergent accommodation, but this was consistent between lenses and test distances. Five measurements were taken at each test distance (distance, 40cm and 25cm). The 5 readings obtained were used to calculate mean spherical equivalent value at each test distance and compared to expected accommodative value to determine lag.

  3. Convergence Insufficiency Symptom Survey (CISS)

    Time frame: 1 week

    Difference in CISS score after one week of multifocal contact lens use vs single vision contact lens use. Minimum score (least symptoms)= 0. Maximum score (worst symptoms) = 60.

  4. Contact Lens Dry Eye Questionnaire- 8 Survey (CLDEQ-8)

    Time frame: 1 week

    CLDEQ-8 score after one week of multifocal contact lenses vs single vision contact lenses. Minimum value (least symptoms) = 0. Maximum Score= 37 (worst symptoms).

  5. Near Phoria at 40cm in Multifocal Contact Lens vs Single Vision Contact Lens

    Time frame: 1 week

    Measured via Modified Thorington

Sponsors and collaborators

Lead sponsor

State University of New York College of Optometry

Other

Collaborators

  • Johnson & Johnson Vision Care, Inc.

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 30, 2016
Registry last updated
Sep 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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