The Impact of Soft Contact Lens Attributes on Symptoms Associated With Digital Eye Strain in Symptomatic Soft Contact Lens Wearers

Not Applicable

Completed

• Conditions: Asthenopia; Myopia
• Interventions: Device: Contact lens with Multifocal Optics; Device: Contact lens with Single Vision Optics

• Registration Number: NCT03585790
• Lead Sponsor: Pete Kollbaum, OD, PhD

Brief Summary

Despite its prevalence, the ocular causes of eye fatigue or unknown and may be related to the cornea/contact lens surface, the accommodative system, the convergence system, overall postural/muscle fatigue, or a combination of these or other causes. The current study aims to systematically investigate the incremental benefits in ameliorating eye fatigue.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-26
• Study First Submitted QC: 2018-07-02
• Study First Posted: 2018-07-13
• Study Start: 2018-09-13
• Primary Completion: 2018-11-02
• Study Completion: 2018-11-02
• Results First Submitted: 2019-09-24
• Status Verified: 2019-12
• Results First Submitted QC: 2019-12-19
• Last Update Submitted: 2019-12-19
• Results First Posted: 2020-01-07
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Self-reported "eye fatigue" at least once per week attributable to digital device use with baseline.
2. Uses a digital device (phone, tablet, computer, etc) at least 4 hours per day
3. Mobile digital device with active data and text plan, able to receive email and text messages
4. Habitual 2-week or monthly silicone single vision hydrogel soft contact lens use; habitually wearing lenses for 6 or more hours per day for 5 or more days per week for the past 30 days
5. Habitual soft contact lens prescription optimized over-refraction within ±0.25 D
6. 18-35 years of age
7. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
8. Vertex corrected refractive cylinder must be -0.75 or less.
9. Visual acuity best correctable to 20/25 or better for each eye
10. The subject must read and sign the Informed Consent form.

Exclusion Criteria

1. A habitual wearer of any of the test lenses
2. Any active conditions that may prevent soft contact lens wear.
3. Any doctor diagnosed, self-reported ocular surface disease or dry eye requiring regular, ongoing treatment
4. Any doctor diagnosed, self-reported accommodative or binocular vision issues
5. History of issues of eye alignment or binocularity by self-report

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Single Vision Optics first, then Multifocal Optics	Contact lens with Single Vision Optics	First Intervention (1 week) Second Intervention (1 week)
Multifocal Optics first, then Single Vision Optics	Contact lens with Multifocal Optics	First Intervention (1 week) Second Intervention (1 week)
Multifocal Optics first, then Single Vision Optics	Contact lens with Single Vision Optics	First Intervention (1 week) Second Intervention (1 week)
Single Vision Optics first, then Multifocal Optics	Contact lens with Multifocal Optics	First Intervention (1 week) Second Intervention (1 week)

Primary Outcome Measures

Name	Time	Method
Subject Reported Eye Fatigue	1 week	Subjective Rating of Eye Fatigue, response to question "How would you rate your overall eye fatigue/tiredness?" on a 0-100 slider visual analog scale, where 0 represents 'Not Noticeable' and 100 represents 'Very Noticeable', with the numerical representation of their visual analog selection displayed to the right of the slider scale. Score reported is rating as described above.

Trial Locations

Locations (1)

Indiana University Clinical Optics Research Lab; 🇺🇸 Bloomington, Indiana, United States