Connecting Contact Lenses and Digital Technology

Asthenopia Clinical Trial

Official title:

Connecting Contact Lenses and Digital Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02921087
• Other study ID #: 923606
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: November 20, 2017

Study information

• Verified date: August 2019
• Source: State University of New York College of Optometry
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 20, 2017
• Est. primary completion date: November 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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)

Related Conditions & MeSH terms

• Asthenopia
• Contact Lenses
• Convergence, Excess
• Ocular Accommodation

Intervention

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

Locations

Country	Name	City	State
United States	SUNY College of Optometry	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
State University of New York College of Optometry	Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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.

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

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. — View 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. — View 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. — View Citation

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

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. — View 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. — View 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.

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Lens Preference	Based on two alternative forced choice method	2 weeks
Secondary	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.	1 week
Secondary	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.	1 week
Secondary	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).	1 week
Secondary	Near Phoria at 40cm in Multifocal Contact Lens vs Single Vision Contact Lens	Measured via Modified Thorington	1 week