N/A
N=23
Connecting Contact Lenses and Digital Technology
Asthenopia · Contact Lenses · Ocular Accommodation · Convergence, Excess
Bottom Line
View on ClinicalTrials.gov: NCT02921087 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Subjective Symptom Improvement — 153.9; 100.7; 272.13 score on a scale — p=0.07
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Test Daily Disposable Soft Contact Lenses (Device); Control Daily Disposable Soft Contact Lenses (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- State University of New York College of Optometry
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Symptom Improvement |
153.9; 100.7; 272.13 | 0.07 |
| SECONDARY Lens Preference |
7; 15 | — |
| SECONDARY Lag of Accommodation in Study Lenses |
1.52; 1.23; 1.06; 0.75; 0.00; 0.22 | 0.01 sig |
| SECONDARY Convergence Insufficiency Symptom Survey (CISS) |
11.2; 10.8 | 0.77 |
| SECONDARY Contact Lens Dry Eye Questionnaire- 8 Survey (CLDEQ-8) |
11.7; 11.0 | 0.69 |
| SECONDARY Near Phoria at 40cm in Multifocal Contact Lens vs Single Vision Contact Lens |
2.3; 2.0 | 0.87 |
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.
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)
Data sourced from ClinicalTrials.gov (NCT02921087). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.