The Eye Institute
Philadelphia, Pennsylvania, 19141, United States
Location status: Recruiting
NCT Number: NCT07282691
The specific aim of this project is to validate clinical tests to be used as outcome measures in studies of mTBI-related vision problems.
Interested in participating?
Request Info18 year–35 year
All sexes
Observational
Philadelphia, Pennsylvania, 19141, United States
Location status: Recruiting
Participants with (n=50) and without (n=100) a history of mTBI will be recruited. Investigators will study the use of a series of visual endurance tests (tests that require sustained visual responses over a period of time). In addition to developing expected values for these tests, investigators will also after qualitative data about discomfort levels during testing.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline and visit 2, which occurs 8 weeks after the baseline visit
The ability to converge the eyes. A near point rod will be used with a 20/30 column of letters. The target will be moved towards the participant slowly, and when diplopia occurs, this will be recorded as the NPC break. The target will then be moved away from the eyes until single vision is regained, and this will be recorded as the NPC recovery. The unit of measure is cm and the NPC will be measured 3 times, with 10 seconds in between each measure, and averaged for each participant.
Time frame: Baseline and visit 2, which occurs 8 weeks after the baseline visit
Compensatory ability to overcome exophoria. A handheld prism bar will be used along with a vertical column of 20/30 letters. The prism will be placed before one eye, and the participant will be asked to maintain clear, single vision. Participants will then report when the target becomes blurred (blur), then double (diplopia), and finally return to single vision (recovery). The unit of measure is prism diopters, and it will be measured three times, with 10 seconds in between each measurement, and averaged for each participant.
Time frame: Baseline and visit 2, which occurs 8 weeks after the baseline visit
This is a measure of vergence velocity. Using a 12-base-out and 3-base-in prism, participants will be instructed to regain clear single vision as quickly as possible. The investigator will count the number of times this can be accomplished in one minut.e
Time frame: Baseline and visit 2, which occurs 8 weeks after the baseline visit
A near point rod will be used along with a column of 20/30 letters. The test will be performed monocularly, first with the left eye covered, and then with the right eye covered. The target will slowly be moved towards the participant, and the participant will be instructed to report when the target becomes blurred. The amplitude of accommodation will be measured 3 times, with 10 seconds in between each measure
Time frame: Baseline and visit 2, which occurs 8 weeks after the baseline visit
This test assesses the speed and endurance of accommodation. A column of 20/30 letter will be used along with a timer, and +2.00D and -2.00D lens flippers. The test will be performed monocularly. The +2.00D lens will be placed before the participant's eye, and the participant will be asked to clear the target as quickly as possible. Once the participant clears the target, the -2.00D lens will be placed before the eye, and the participant will be asked to report when the target becomes clear again. This will be repeated as many times as possible within one minute. The investigator will report how many times this occurs in one minute.
Contact information is provided by the study sponsor or research team.
Katie Holmbeck, BS
CONTACT
Mitchell Scheiman, OD, PhD
CONTACT
Salus University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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