Validation of Clinical Outcome Measures Specific to mTBI-Related Oculomotor Disorders

NCT07282691 | Recruiting

• 1 other identifier: 2406010608
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The specific aim of this project is to validate clinical tests to be used as outcome measures in studies of mTBI-related vision problems.

Conditions

MTBI - Mild Traumatic Brain Injury

Keywords

mTBI; convergence insufficiency; concussion; concussion-related vision disorders; vision rehabilitation; vision therapy

Outcome Measures

Primary Outcomes (1)

• Number of participants with abnormal near point of convergence

  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.

  Baseline and visit 2, which occurs 8 weeks after the baseline visit

Secondary Outcomes (4)

• Number of participants with abnormal positive fusional vergence

  Baseline and visit 2, which occurs 8 weeks after the baseline visit

• Number of participants with abnormal vergence facility

  Baseline and visit 2, which occurs 8 weeks after the baseline visit

• Number of participants with abnormal accommodative amplitude

  Baseline and visit 2, which occurs 8 weeks after the baseline visit

• Number of participants with abnormal accommodative facility

  Baseline and visit 2, which occurs 8 weeks after the baseline visit

Study Arms (2)

control participants

no history of mTBI

mTBI group

history of mTBI

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

mTBI

You may qualify if:

• Diagnosis of mTBI within previous 1 to 6 months
• Distance visual acuity better than or equal to 20/25 in each eye
• Score \>21 on Convergence Insufficiency Symptom Survey

You may not qualify if:

• Diagnosis of moderate or severe TBI; \> 30-min loss of consciousness
• Not wearing required refractive error)
• Disease(s) known to affect oculomotor system (multiple sclerosis, Graves orbitopathy, myasthenia gravis, diabetes mellitus, or Parkinson disease)-Manifest strabismus or intraocular injury (evaluated at vision examination)
• Cognitive delays that may impact testing

Sponsors & Collaborators

• Salus University: lead

Study Sites (1)

The Eye Institute

Philadelphia, Pennsylvania, 19141, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion; Ocular Motility Disorders

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Cranial Nerve Diseases; Eye Diseases

Study Officials

• Mitchell Scheiman

  Pennsylvania College of Optometry at Drexel University

  STUDY CHAIR

Central Study Contacts

Katie Holmbeck, BS

CONTACT

2157801429; kh3482@drexel.edu

Mitchell Scheiman, OD, PhD

CONTACT

2157801427; ms5758@drexel.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2025
• First Posted: December 15, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): September 29, 2028
• Study Completion (Estimated): September 29, 2028
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)