Connecting Contact Lenses and Digital Technology

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 20, 2017

Detailed Description

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.

Interventions

  • Device: Test Daily Disposable Soft Contact Lenses
    • Worn daily for 7 +/- 2 days
  • Device: Control Daily Disposable Soft Contact Lenses
    • Worn daily for 7 +/- 2 days

Arms, Groups and Cohorts

  • Other: Test followed by control
    • Subjects will be randomized in a 1:1 ratio based on a randomization schedule according to sequentially assigned subject numbers to the test daily disposable soft contact lenses at the first visit. Subjects will crossover to the control daily disposable soft contact lenses at the second visit.
  • Other: Control followed by test
    • Subjects will be randomized in a 1:1 ratio based on a randomization schedule according to sequentially assigned subject numbers to the control daily disposable soft contact lenses at the first visit. Subjects will crossover to the test daily disposable soft contact lenses at the second visit.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Lens Preference
    • Time Frame: 2 weeks
    • Based on two alternative forced choice method
  • 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.
  • 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.
  • 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).
  • Near Phoria at 40cm in Multifocal Contact Lens vs Single Vision Contact Lens
    • Time Frame: 1 week
    • Measured via Modified Thorington

Participating in This Clinical Trial

Inclusion Criteria

1. 18 to 35 years of age 2. Spectacle prescription of -0.75 to -6.00 D sphere with no more than 0.75 diopters of refractive cylinder 3. Current single-vision soft contact lens wearer 4. Monocular acuity of 20/25 or better in each eye (Snellen) 5. Self-reported minimum of 6 hours a day on digital devices 6. Self-reported complaint of eyestrain on digital devices 7. No ocular pathology and/or history of eye surgery 8. No history of strabismus or strabismus surgery 9. No gas permeable lens wear for at least 3 months 10. Subjects may not be optometrists, opticians or optometry students Exclusion Criteria:

1. Corneal staining, blepharitis and/or Meibomian Gland Dysfunction (MGD) worse than Grade 2 using the Efron Grading Scale 2. Negative Relative Accommodation (NRA) less than +1.50 D 3. Exophoria at near > 6 prism diopters10 4. Vertical phoria > 1 prism diopter 5. Presence of tropia 6. Response of 3 or higher on question 2b of the Contact Lens Dry Eye Questionnaire- 8 (CLDEQ-8) 7. Unacceptable contact lens fit (i.e. substantially decentered, excessive movement)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 35 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • State University of New York College of Optometry
  • Collaborator
    • Johnson & Johnson Vision Care, Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Danielle Iacono, Assistant Clinical Professor – State University of New York College of Optometry
  • Overall Official(s)
    • Danielle Iacono, OD, Principal Investigator, SUNY Optometry

References

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Rueff, Erin. Contact Lens Induced Dry Eye And Binocular Vision Disorders: A Study Of Similar Symptoms. (2014): Networked Digital Library of Theses & Dissertations. Oct. 2015.

Cooper, Jeffrey S., et al. Care of the patient with accommodative and vergence dysfunction. American Optometric Association. USA (1998): 5-10.

Rouse MW, Borsting EJ, Mitchell GL, Scheiman M, Cotter SA, Cooper J, Kulp MT, London R, Wensveen J; Convergence Insufficiency Treatment Trial Group. Validity and reliability of the revised convergence insufficiency symptom survey in adults. Ophthalmic Physiol Opt. 2004 Sep;24(5):384-90. doi: 10.1111/j.1475-1313.2004.00202.x.

Chalmers RL, Begley CG, Moody K, Hickson-Curran SB. Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) and opinion of contact lens performance. Optom Vis Sci. 2012 Oct;89(10):1435-42. doi: 10.1097/OPX.0b013e318269c90d.

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Richdale K, Mitchell GL, Zadnik K. Comparison of multifocal and monovision soft contact lens corrections in patients with low-astigmatic presbyopia. Optom Vis Sci. 2006 May;83(5):266-73. doi: 10.1097/01.opx.0000216098.62165.34.

Fedtke C, Bakaraju RC, Ehrmann K, Chung J, Thomas V, Holden BA. Visual performance of single vision and multifocal contact lenses in non-presbyopic myopic eyes. Cont Lens Anterior Eye. 2016 Feb;39(1):38-46. doi: 10.1016/j.clae.2015.07.005. Epub 2015 Jul 27.

Efron, Nathan. Clinical application of grading scales for contact lens complications. Optician 213.5604 (1997): 26-34.

Morgan MW. The clinical aspects of accommodation and convergence. Am J Optom 1944; 21:301-13.

Hayes JR, Sheedy JE, Stelmack JA, Heaney CA. Computer use, symptoms, and quality of life. Optom Vis Sci. 2007 Aug;84(8):738-44. doi: 10.1097/OPX.0b013e31812f7546.

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