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.
67 studies on the registry are indexed under Asthenopia; 10 are open to participants now.
This study's enrollment of 45 is below the median of 56 across 56 interventional studies indexed under Asthenopia.
Browse Asthenopia studies →Pete Kollbaum, OD, PhD is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pete Kollbaum, OD, PhD