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Novel Amblyopia Treatment With Virtual Reality Games

Primary Purpose

Amblyopia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Optical Correction
Therapeutic Dichoptic Virtual Reality Games
Sponsored by
Marjean Kulp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amblyopia

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients ages 5 to 17 years of age Moderate to severe unilateral amblyopia (logMAR best corrected visual acuity 0.3 to 1.3) associated with anisometropia and/or strabismus of ≤5pd Age normal VA in the nonamblyopic eye Spectacle correction (if required) worn for at least 16 weeks, or until stability of VA is demonstrated (<0.1 logMAR change by the same testing method measured on 2 exams at least 8 weeks apart) Interocular difference of ≥ 3 lines No amblyopia treatment in the past 2 weeks An interpupillary distance of 52-72 mm (inclusive) Exclusion Criteria: Myopia greater than -6.00 diopters (D) spherical equivalent in either eye. Previous intraocular or refractive surgery. Previous dichoptic treatment > 2 weeks in duration Ocular co-morbidity that may reduce visual acuity determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above visual acuity criteria are met). Diplopia more than once per week over the last week prior to enrollment by parental report. Down syndrome or cerebral palsy. Light-induced seizures Known simulator sickness Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities are not excluded.

Sites / Locations

  • The Ohio State University College of OptometryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Optical Correction alone

Therapeutic (Dichoptic) Virtual Reality Games plus Continued Optical Correction

Arm Description

Optical correction alone (16 weeks) (Each participant will complete both study conditions.)

Therapeutic (Dichoptic) Virtual Reality Games plus continued optical correction (16 weeks) (Each participant will complete both study conditions.)

Outcomes

Primary Outcome Measures

Difference in Mean Change in Amblyopic Eye Visual Acuity
Optical correction worn for testing using Amblyopia Treatment Study (ATS) protocol; HOTV for ages 5-6 years; E-ETDRS for ages 7 years and older

Secondary Outcome Measures

Difference in Change in Stereoacuity/Binocularity
Optical correction worn for testing. Stereoacuity scores (seconds of arc) calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) tests. Lower scores indicate better stereoacuity. Nil (4000) defined as an incorrect response (or lack of an attempt) on the butterfly without a correct response on 800 seconds of arc level of Randot Preschool stereoacuity test. Stereoacuity scores will be ordered and assigned a rank score. Change in stereoacuity will be calculated as the difference in change in ranked score.
Difference in Mean Change in Amblyopic-Eye Contrast Sensitivity
Optical correction worn for testing. Spot Checks;Contrast sensitivity scores range from unable (<0.90), and then from 0.90 to 2.05 (by 0.05 log contrast sensitivity units).
Difference in Mean Change in Attention
Optical correction worn for testing. The Children's Color Trails Test (CCTT) is a neuropsychological standardized test that measures attention, divided attention, and speed of mental processing.
Difference in Mean Change in reading eye movements
Optical correction worn for testing with Readalyzer eye tracker.
Difference in Mean Change in visual-motor integration
Optical correction worn for testing. Beery Visual-Motor Integration; standard scores with mean of 100, standard deviation of 15
Difference in Mean Change in Pediatric Eye Questionnaire (PedEyeQ)
Pediatric Eye Questionnaire (PedEyeQ) domain score; scores for questionnaire items will be obtained from published look-up tables available at www.pedig.net; scaled to score from 0 to 100 (worst to best)

Full Information

First Posted
September 15, 2023
Last Updated
September 22, 2023
Sponsor
Marjean Kulp
Collaborators
Beta Sigma Kappa - College of Optometrists in Vision Development, VividVision
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1. Study Identification

Unique Protocol Identification Number
NCT06049459
Brief Title
Novel Amblyopia Treatment With Virtual Reality Games
Official Title
Novel Amblyopia Treatment With Dichoptic, Disparity-guided, Hand-Eye Coordination Enhanced, Serious, Virtual Reality Games
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marjean Kulp
Collaborators
Beta Sigma Kappa - College of Optometrists in Vision Development, VividVision

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this study is to compare the change in amblyopic eye acuity between treatment periods in children with amblyopia, aged 5-17 years. The main question it aims to answer is: Is a 16-week course of amblyopia treatment using Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for approx. 25 min/day, 6 days/week more effective for improvement in amblyopic-eye VA, binocularity (stereoacuity, suppression, alignment), contrast sensitivity, attention, oculomotor function, visual-motor integration, and quality of life than 16 weeks of continued glasses alone? Participants will each serve as their own control and complete: Treatment period 1: Continued optical correction (glasses) alone for 16 weeks; Treatment period 2: Vivid Vision Therapeutic (Dichoptic) Virtual Reality Games for 16 weeks (approx. 25min/day, 6 days/week) plus continued optical correction

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This is a within-subject study, and all participants complete both study conditions. Each participant completes 16 weeks of optical correction alone (if needed) followed by 16 weeks of Therapeutic (Dichoptic) Virtual Reality Games plus continued optical correction. Each subject serves as their own control.
Masking
Outcomes Assessor
Masking Description
Outcomes assessor will be masked to past performance and adherence.
Allocation
Non-Randomized
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Optical Correction alone
Arm Type
Active Comparator
Arm Description
Optical correction alone (16 weeks) (Each participant will complete both study conditions.)
Arm Title
Therapeutic (Dichoptic) Virtual Reality Games plus Continued Optical Correction
Arm Type
Experimental
Arm Description
Therapeutic (Dichoptic) Virtual Reality Games plus continued optical correction (16 weeks) (Each participant will complete both study conditions.)
Intervention Type
Device
Intervention Name(s)
Optical Correction
Intervention Description
Optical correction (if needed)
Intervention Type
Device
Intervention Name(s)
Therapeutic Dichoptic Virtual Reality Games
Intervention Description
Virtual Reality Game play for amblyopia treatment
Primary Outcome Measure Information:
Title
Difference in Mean Change in Amblyopic Eye Visual Acuity
Description
Optical correction worn for testing using Amblyopia Treatment Study (ATS) protocol; HOTV for ages 5-6 years; E-ETDRS for ages 7 years and older
Time Frame
Baseline to 16 weeks versus 16 weeks to 32 weeks
Secondary Outcome Measure Information:
Title
Difference in Change in Stereoacuity/Binocularity
Description
Optical correction worn for testing. Stereoacuity scores (seconds of arc) calculated based on the Randot Butterfly (scores: 2000, Nil) and Randot Preschool stereoacuity (scores: 800, 400, 200, 100, 60 and 40) tests. Lower scores indicate better stereoacuity. Nil (4000) defined as an incorrect response (or lack of an attempt) on the butterfly without a correct response on 800 seconds of arc level of Randot Preschool stereoacuity test. Stereoacuity scores will be ordered and assigned a rank score. Change in stereoacuity will be calculated as the difference in change in ranked score.
Time Frame
Baseline to 16 weeks versus 16 weeks to 32 weeks
Title
Difference in Mean Change in Amblyopic-Eye Contrast Sensitivity
Description
Optical correction worn for testing. Spot Checks;Contrast sensitivity scores range from unable (<0.90), and then from 0.90 to 2.05 (by 0.05 log contrast sensitivity units).
Time Frame
Baseline to 16 weeks versus 16 weeks to 32 weeks
Title
Difference in Mean Change in Attention
Description
Optical correction worn for testing. The Children's Color Trails Test (CCTT) is a neuropsychological standardized test that measures attention, divided attention, and speed of mental processing.
Time Frame
Baseline to 16 weeks versus 16 weeks to 32 weeks
Title
Difference in Mean Change in reading eye movements
Description
Optical correction worn for testing with Readalyzer eye tracker.
Time Frame
Baseline to 16 weeks versus 16 weeks to 32 weeks
Title
Difference in Mean Change in visual-motor integration
Description
Optical correction worn for testing. Beery Visual-Motor Integration; standard scores with mean of 100, standard deviation of 15
Time Frame
Baseline to 16 weeks versus 16 weeks to 32 weeks
Title
Difference in Mean Change in Pediatric Eye Questionnaire (PedEyeQ)
Description
Pediatric Eye Questionnaire (PedEyeQ) domain score; scores for questionnaire items will be obtained from published look-up tables available at www.pedig.net; scaled to score from 0 to 100 (worst to best)
Time Frame
Baseline to 16 weeks versus 16 weeks to 32 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients ages 5 to 17 years of age Moderate to severe unilateral amblyopia (logMAR best corrected visual acuity 0.3 to 1.3) associated with anisometropia and/or strabismus of ≤5pd Age normal VA in the nonamblyopic eye Spectacle correction (if required) worn for at least 16 weeks, or until stability of VA is demonstrated (<0.1 logMAR change by the same testing method measured on 2 exams at least 8 weeks apart) Interocular difference of ≥ 3 lines No amblyopia treatment in the past 2 weeks An interpupillary distance of 52-72 mm (inclusive) Exclusion Criteria: Myopia greater than -6.00 diopters (D) spherical equivalent in either eye. Previous intraocular or refractive surgery. Previous dichoptic treatment > 2 weeks in duration Ocular co-morbidity that may reduce visual acuity determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above visual acuity criteria are met). Diplopia more than once per week over the last week prior to enrollment by parental report. Down syndrome or cerebral palsy. Light-induced seizures Known simulator sickness Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities are not excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marjean T Kulp, OD, MS
Phone
614-688-3336
Email
kulp.6@osu.edu
Facility Information:
Facility Name
The Ohio State University College of Optometry
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marjean T Kulp, OD, MS
Phone
614-688-3336
Email
kulp.6@osu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Novel Amblyopia Treatment With Virtual Reality Games

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