Connecting Contact Lenses and Digital Technology
1 other identifier
interventional
23
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2016
CompletedFirst Posted
Study publicly available on registry
September 30, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 20, 2017
CompletedResults Posted
Study results publicly available
September 11, 2019
CompletedSeptember 11, 2019
August 1, 2019
11 months
September 29, 2016
July 15, 2019
August 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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).
Baseline and after 1 week of wearing each lens.
Secondary Outcomes (5)
Lens Preference
2 weeks
Lag of Accommodation in Study Lenses
1 week
Convergence Insufficiency Symptom Survey (CISS)
1 week
Contact Lens Dry Eye Questionnaire- 8 Survey (CLDEQ-8)
1 week
Near Phoria at 40cm in Multifocal Contact Lens vs Single Vision Contact Lens
1 week
Study Arms (2)
Test followed by control
OTHERSubjects 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.
Control followed by test
OTHERSubjects 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.
Interventions
Worn daily for 7 +/- 2 days
Worn daily for 7 +/- 2 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SUNY College of Optometry
New York, New York, 10036, United States
Related Publications (11)
Ember, Sydney. Brands Woo Millennials With a Wink, an Emoji or Whatever It Takes. New York Times 28 September 2015: B1.
BACKGROUNDRueff, Erin. Contact Lens Induced Dry Eye And Binocular Vision Disorders: A Study Of Similar Symptoms. (2014): Networked Digital Library of Theses & Dissertations. Oct. 2015.
BACKGROUNDCooper, Jeffrey S., et al. Care of the patient with accommodative and vergence dysfunction. American Optometric Association. USA (1998): 5-10.
BACKGROUNDRouse 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.
PMID: 15315652BACKGROUNDChalmers 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.
PMID: 22960615BACKGROUNDJaschinski 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.
PMID: 11913842BACKGROUNDRichdale 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.
PMID: 16699438BACKGROUNDFedtke 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.
PMID: 26228543BACKGROUNDEfron, Nathan. Clinical application of grading scales for contact lens complications. Optician 213.5604 (1997): 26-34.
BACKGROUNDMorgan MW. The clinical aspects of accommodation and convergence. Am J Optom 1944; 21:301-13.
BACKGROUNDHayes 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.
PMID: 17700327BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Danielle Iacono, OD
- Organization
- SUNY College of Optometry Clinical Vision Research Center
Study Officials
- PRINCIPAL INVESTIGATOR
Danielle Iacono, OD
SUNY Optometry
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Clinical Professor
Study Record Dates
First Submitted
September 29, 2016
First Posted
September 30, 2016
Study Start
January 1, 2017
Primary Completion
November 20, 2017
Study Completion
November 20, 2017
Last Updated
September 11, 2019
Results First Posted
September 11, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share