Connecting Contact Lenses and Digital Technology
Primary Purpose
Asthenopia, Contact Lenses, Ocular Accommodation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Test Daily Disposable Soft Contact Lenses
Control Daily Disposable Soft Contact Lenses
Sponsored by
About this trial
This is an interventional treatment trial for Asthenopia
Eligibility Criteria
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)
Sites / Locations
- SUNY College of Optometry
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Test followed by control
Control followed by test
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Subjective Symptom Improvement
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
Lens Preference
Based on two alternative forced choice method
Lag of Accommodation in Study Lenses
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)
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)
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
Measured via Modified Thorington
Full Information
NCT ID
NCT02921087
First Posted
September 29, 2016
Last Updated
August 19, 2019
Sponsor
State University of New York College of Optometry
Collaborators
Johnson & Johnson Vision Care, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02921087
Brief Title
Connecting Contact Lenses and Digital Technology
Official Title
Connecting Contact Lenses and Digital Technology
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
November 20, 2017 (Actual)
Study Completion Date
November 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York College of Optometry
Collaborators
Johnson & Johnson Vision Care, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthenopia, Contact Lenses, Ocular Accommodation, Convergence, Excess
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test followed by control
Arm Type
Other
Arm Description
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.
Arm Title
Control followed by test
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Test Daily Disposable Soft Contact Lenses
Intervention Description
Worn daily for 7 +/- 2 days
Intervention Type
Device
Intervention Name(s)
Control Daily Disposable Soft Contact Lenses
Intervention Description
Worn daily for 7 +/- 2 days
Primary Outcome Measure Information:
Title
Subjective Symptom Improvement
Description
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).
Time Frame
Baseline and after 1 week of wearing each lens.
Secondary Outcome Measure Information:
Title
Lens Preference
Description
Based on two alternative forced choice method
Time Frame
2 weeks
Title
Lag of Accommodation in Study Lenses
Description
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.
Time Frame
1 week
Title
Convergence Insufficiency Symptom Survey (CISS)
Description
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.
Time Frame
1 week
Title
Contact Lens Dry Eye Questionnaire- 8 Survey (CLDEQ-8)
Description
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).
Time Frame
1 week
Title
Near Phoria at 40cm in Multifocal Contact Lens vs Single Vision Contact Lens
Description
Measured via Modified Thorington
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle Iacono, OD
Organizational Affiliation
SUNY Optometry
Official's Role
Principal Investigator
Facility Information:
Facility Name
SUNY College of Optometry
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Ember, Sydney. Brands Woo Millennials With a Wink, an Emoji or Whatever It Takes. New York Times 28 September 2015: B1.
Results Reference
background
Citation
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.
Results Reference
background
Citation
Cooper, Jeffrey S., et al. Care of the patient with accommodative and vergence dysfunction. American Optometric Association. USA (1998): 5-10.
Results Reference
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PubMed Identifier
15315652
Citation
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.
Results Reference
background
PubMed Identifier
22960615
Citation
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.
Results Reference
background
PubMed Identifier
11913842
Citation
Jaschinski W. The proximity-fixation-disparity curve and the preferred viewing distance at a visual display as an indicator of near vision fatigue. Optom Vis Sci. 2002 Mar;79(3):158-69. doi: 10.1097/00006324-200203000-00010.
Results Reference
background
PubMed Identifier
16699438
Citation
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.
Results Reference
background
PubMed Identifier
26228543
Citation
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.
Results Reference
background
Citation
Efron, Nathan. Clinical application of grading scales for contact lens complications. Optician 213.5604 (1997): 26-34.
Results Reference
background
Citation
Morgan MW. The clinical aspects of accommodation and convergence. Am J Optom 1944; 21:301-13.
Results Reference
background
PubMed Identifier
17700327
Citation
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.
Results Reference
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Connecting Contact Lenses and Digital Technology
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