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Connecting Contact Lenses and Digital Technology

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ClinicalTrials.gov Identifier: NCT02921087
Recruitment Status : Completed
First Posted : September 30, 2016
Results First Posted : September 11, 2019
Last Update Posted : September 11, 2019
Sponsor:
Collaborator:
Johnson & Johnson Vision Care, Inc.
Information provided by (Responsible Party):
Danielle Iacono, State University of New York College of Optometry

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asthenopia Contact Lenses Ocular Accommodation Convergence, Excess Device: Test Daily Disposable Soft Contact Lenses Device: Control Daily Disposable Soft Contact Lenses Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Connecting Contact Lenses and Digital Technology
Study Start Date : January 2017
Actual Primary Completion Date : November 20, 2017
Actual Study Completion Date : November 20, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
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.
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

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.
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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02921087


Locations
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United States, New York
SUNY College of Optometry
New York, New York, United States, 10036
Sponsors and Collaborators
State University of New York College of Optometry
Johnson & Johnson Vision Care, Inc.
Investigators
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Principal Investigator: Danielle Iacono, OD SUNY Optometry
  Study Documents (Full-Text)

Documents provided by Danielle Iacono, State University of New York College of Optometry:
Study Protocol  [PDF] May 30, 2017
Statistical Analysis Plan  [PDF] April 27, 2018


Publications:
Ember, Sydney. Brands Woo Millennials With a Wink, an Emoji or Whatever It Takes. New York Times 28 September 2015: B1.
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.
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.

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Responsible Party: Danielle Iacono, Assistant Clinical Professor, State University of New York College of Optometry
ClinicalTrials.gov Identifier: NCT02921087     History of Changes
Other Study ID Numbers: 923606
First Posted: September 30, 2016    Key Record Dates
Results First Posted: September 11, 2019
Last Update Posted: September 11, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Asthenopia
Eye Diseases