Clinical trial NCT02921087: Connecting Contact Lenses and Digital Technology
Official title: Connecting Contact Lenses and Digital Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthenopia
Contact Lenses
Ocular Accommodation
Convergence, Excess
Lead sponsor: State University of New York College of Optometry
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson Vision Care, Inc.
First posted: 2016-09-30
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Subjective Symptom Improvement
timeFrame: Baseline and after 1 week of wearing each lens.
Secondary outcomes:
measure: Lens Preference
timeFrame: 2 weeks
measure: Lag of Accommodation in Study Lenses
timeFrame: 1 week
measure: Convergence Insufficiency Symptom Survey (CISS)
timeFrame: 1 week
measure: Contact Lens Dry Eye Questionnaire- 8 Survey (CLDEQ-8)
timeFrame: 1 week
measure: Near Phoria at 40cm in Multifocal Contact Lens vs Single Vision Contact Lens
timeFrame: 1 week
Other outcomes:
Locations:
city: New York
country: United States
facility: SUNY College of Optometry
state: New York
Study officials:
affiliation: SUNY Optometry
name: Danielle Iacono, OD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ember, Sydney. Brands Woo Millennials With a Wink, an Emoji or Whatever It Takes. New York Times 28 September 2015: B1.
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.
citation: Cooper, Jeffrey S., et al. Care of the patient with accommodative and vergence dysfunction. American Optometric Association. USA (1998): 5-10.
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.
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.
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.
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.
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.
citation: Efron, Nathan. Clinical application of grading scales for contact lens complications. Optician 213.5604 (1997): 26-34.
citation: Morgan MW. The clinical aspects of accommodation and convergence. Am J Optom 1944; 21:301-13.
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.