Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT03529799
NCT03529799TerminatedNot Applicable

Examining Disparity Driven Vergence as a Potential Diagnostic Test for Mild Traumatic Brain Injury (mTBI)

University of Miami1 site in 1 country40 target enrollmentStarted: April 20, 2018Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
40
Locations
1
Primary Endpoint
Pseudorandom Ternary Sequence of Frequency
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study aims to determine the validity and safety of disparity driven vergence using a portable goggle system (I-PAS) using a pseudorandom ternary sequence of frequencies for testing.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Age 18 to 65
  • •Both females and males

Exclusion Criteria

  • •Central processing disorder
  • •Impaired vision without corrective lenses (max 20/60 uncorrected)
  • •Moderate to severe hearing loss (>55 decibels (dB) pure tone audiometry (PTA), <50% word identification)
  • •Vestibular disorder except for patients recruited for subjects recruited with a history of mild traumatic brain injury to compare to normal participants
  • •History of ear surgery other than myringotomy with or without tube placement
  • •Pregnant women
  • •Prisoners
  • •Adults unable to consent

Arms & Interventions

Injured Participants

Experimental

Participants with mild traumatic brain injury (mTBI) tested using the I-PAS goggles

Intervention: I-PAS Goggles (Device)

Uninjured Participants

Active Comparator

Participants with no mild traumatic brain injury (mTBI) tested using the I-PAS goggles

Intervention: I-PAS Goggles (Device)

Outcomes

Primary Outcomes

Pseudorandom Ternary Sequence of Frequency

Time Frame: 15 minutes

Pseudorandom Ternary Sequence of Frequency (reported in Hertz) will be measured via mergence testing using the IPAS goggles.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Michael E. Hoffer

Professor

University of Miami

Study Sites (1)

Loading locations...

Similar Trials

Unknown
Not Applicable
Objective Assessment of Disparity Vergence After Treatment of Symptomatic CI in ChildrenConvergence Insufficiency
NCT03248336Salus University60
Unknown
Not Applicable
Characteristics of the Vergence Responses of Binocularly Normal Subjects After a Vision Therapy ProtocolVision DisordersEye; Movement Disorder (Binocular)Vision TherapyBinocular Vision Disorder
NCT05208658Universitat Politècnica de Catalunya34
Completed
Not Applicable
Diagnosis of Gestational Diabetes in Eldoret, KenyaDiabetes, Gestational
NCT02978807Indiana University935
Completed
Not Applicable
Differing Completion Rates of DIABETES Education on Patient Reported OutcomesDiabetes Mellitus, Type 2Patient Education as Topic
NCT06419907University of Liverpool120
Completed
Phase 1
A Multi-Centre Clinical Trial to Evaluate a Left-Right Design in Adults With Mild to Moderate Atopic DermatitisAtopic Dermatitis
NCT02103725LEO Pharma30