Clinical trial NCT04691427: Effectiveness of Virtual Reality Vision Therapy - VERVE
Official title: Effectiveness of Vision Therapy in a Virtual Reality Headset
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Convergence Insufficiency
Lead sponsor: OculoMotor Technologies
Sponsor class: INDUSTRY
Collaborators: name: New Jersey Institute of Technology
name: Salus University
First posted: 2020-12-31
Enrollment: 50
Sex: ALL
Minimum age (years): 9
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to see how well the treatment of a participant's eye coordination and/or focusing problems improves eye muscle responses and symptoms of eyestrain. We will use an entertainment device called a virtual reality headset to play a custom-designed video game to find out how well the treatment of binocular vision improves a participant's coordination and/or focusing problem. The virtual reality headset uses eye-trackers to monitor progress in a totally objective manner. Objective testing allows the doctor to determine the results without relying on a participant's ability to answer questions or respond verbally in any way. We will compare the results of a participant before and after playing the video game.


Eligibility criteria: Inclusion Criteria:

* Age 9 years and older
* CISS score ≥ 16
* Best-corrected distance visual acuity of 20/25 or better in each eye
* Random dot stereopsis appreciation of 500 seconds of arc or better
* Parent or subject understands the protocol and is willing to enroll in the study

Exclusion Criteria:

* Constant strabismus at distance or near
* Vertical heterophoria ≥ 2 ∆ at distance or near
* ≥ 2 line interocular difference in best-corrected visual acuity
* Near point of accommodation \> 20 cm in either eye as measured by push-up method
* Manifest or latent nystagmus
* Non-strabismic binocular vision and accommodative disorders associated with known disease of the brain
* Diseases known to affect accommodation, vergence, or ocular motility such as multiple sclerosis, Graves orbitopathy, myasthenia gravis, diabetes mellitus, Parkinson disease
* Any ocular or systemic medication known to affect accommodation or vergence such as anti-anxiety agents (e.g., Librium or Valium), anti-arrhythmic agents (e.g., Cifenline, Cibenzoline), anti-cholinergics, bladder spasmolytic drugs (e.g., Propiverine), hydroxychloroquine, chloroquine, phenothiazines (e.g., Compazine, Mellaril, Thorazine), tricyclic antidepressants (e.g., Elavil, Nortriptyline, Tofranil)
* Inability to comprehend and/or perform any study-related test or procedure

Primary outcomes:
measure: Positive Fusional Vergence
timeFrame: up to 4 weeks post-therapy
measure: Near Point of Convergence
timeFrame: up to 4 weeks post-therapy
Secondary outcomes:
measure: Convergence Insufficiency Symptom Survey (CISS)
timeFrame: up to 4 weeks post-therapy
measure: Vision Quality of Life with Time Survey (VisQuaL-T)
timeFrame: up to 4 weeks post-therapy
measure: Core Elements of Gaming Experience Questionnaire
timeFrame: up to 4 weeks post-therapy
Other outcomes:
Locations:
city: Newark
country: United States
facility: OculoMotor Technologies
state: New Jersey
city: Philadelphia
country: United States
facility: The Eye Institute at Salus University
state: Pennsylvania
Study officials:
affiliation: OculoMotor Technologies
name: Chang Yaramothu, PhD
role: STUDY_CHAIR
affiliation: OculoMotor Technologies
name: Tara L Alvarez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: OculoMotor Technologies
name: Mitchell M Scheiman, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References: