An interventional study of Contact lens with Multifocal Optics and Contact lens with Single Vision Optics in Asthenopia and Myopia, sponsored by Pete Kollbaum, OD, PhD. Completed at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-07.
Sponsored by Pete Kollbaum, OD, PhD · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
First Intervention (1 week) Second Intervention (1 week)
Device: Contact lens with Multifocal Optics · Device: Contact lens with Single Vision Optics
First Intervention (1 week) Second Intervention (1 week)
Device: Contact lens with Multifocal Optics · Device: Contact lens with Single Vision Optics
This contact lens has optics to aid the accommodative and convergence systems
This contact lens has standard single vision optics
Subject Reported Eye Fatigue
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.
Time frame: 1 week
| Milestone | Multifocal Optics First, Then Single Vision Optics | Single Vision Optics First, Then Multifocal Optics |
|---|---|---|
| Started | 23 | 22 |
| Completed | 23 | 22 |
| Not completed | 0 | 0 |
| Milestone | Multifocal Optics First, Then Single Vision Optics | Single Vision Optics First, Then Multifocal Optics |
|---|---|---|
| Started | 23 | 22 |
| Completed | 23 | 22 |
| Not completed | 0 | 0 |
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.
| units on a scale | Multifocal Optics First, Then Single Vision Optics | Single Vision Optics First, Then Multifocal Optics | Total |
|---|---|---|---|
| Single Vision | 18 (6.5 to 39) | 21 (15.25 to 48) | 21 (11 to 45) |
| Multifocal | 17 (6.5 to 33.5) | 21.5 (16.75 to 38.75) | 20 (8 to 38) |
Collected over through study completion, an average of 1 month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Multifocal Optics First, Then Single Vision Optics | 0/23 (0%) | 0/23 (0%) | 0/23 (0%) |
| Single Vision Optics First, Then Multifocal Optics | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Age, Categorical(Participants) | Multifocal Optics First, Then Single Vision Optics | Single Vision Optics First, Then Multifocal Optics | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 23 | 22 | 45 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Multifocal Optics First, Then Single Vision Optics | Single Vision Optics First, Then Multifocal Optics | Total |
|---|---|---|---|
| Mean | 21.87 ± 3.37 | 22.5 ± 3.01 | 22.17 ± 3.25 |
| Sex: Female, Male(Participants) | Multifocal Optics First, Then Single Vision Optics | Single Vision Optics First, Then Multifocal Optics | Total |
|---|---|---|---|
| Female | 19 | 16 | 35 |
| Male | 4 | 6 | 10 |
| Ethnicity (NIH/OMB)(Participants) | Multifocal Optics First, Then Single Vision Optics | Single Vision Optics First, Then Multifocal Optics | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 4 | 5 |
| Not Hispanic or Latino | 22 | 18 | 40 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Multifocal Optics First, Then Single Vision Optics | Single Vision Optics First, Then Multifocal Optics | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 3 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 21 | 16 | 37 |
| More than one race | 0 | 2 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Multifocal Optics First, Then Single Vision Optics | Single Vision Optics First, Then Multifocal Optics | Total |
|---|---|---|---|
| United States | 23 | 22 | 45 |
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Pete Kollbaum, OD, PhD