Ny amblyopibehandling med Virtual Reality-spill
Ny amblyopibehandling med dikoptiske, ulikhetsguidede, hånd-øye-koordinering forbedret, seriøse virtuelle virkelighetsspill
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Ohio
-
Columbus, Ohio, Forente stater, 43210
- The Ohio State University College of Optometry
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Optical Correction alone
Optical correction alone (16 weeks) (Each participant will complete both study conditions.) |
Optical correction (if needed) |
|
Eksperimentell: Therapeutic (Dichoptic) Virtual Reality Games plus Continued Optical Correction
Therapeutic (Dichoptic) Virtual Reality Games plus continued optical correction (16 weeks) (Each participant will complete both study conditions.) |
Optical correction (if needed) Virtual Reality Game play for amblyopia treatment |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Difference in Mean Change in Amblyopic Eye Visual Acuity
Tidsramme: Baseline to 16 weeks versus 16 weeks to 32 weeks
|
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 |
Baseline to 16 weeks versus 16 weeks to 32 weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Difference in Change in Stereoacuity/Binocularity
Tidsramme: Baseline to 16 weeks versus 16 weeks to 32 weeks
|
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. |
Baseline to 16 weeks versus 16 weeks to 32 weeks
|
|
Difference in Mean Change in Amblyopic-Eye Contrast Sensitivity
Tidsramme: Baseline to 16 weeks versus 16 weeks to 32 weeks
|
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). |
Baseline to 16 weeks versus 16 weeks to 32 weeks
|
|
Difference in Mean Change in Attention
Tidsramme: Baseline to 16 weeks versus 16 weeks to 32 weeks
|
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. |
Baseline to 16 weeks versus 16 weeks to 32 weeks
|
|
Difference in Mean Change in reading eye movements
Tidsramme: Baseline to 16 weeks versus 16 weeks to 32 weeks
|
Optical correction worn for testing with Readalyzer eye tracker. |
Baseline to 16 weeks versus 16 weeks to 32 weeks
|
|
Difference in Mean Change in visual-motor integration
Tidsramme: Baseline to 16 weeks versus 16 weeks to 32 weeks
|
Optical correction worn for testing. Beery Visual-Motor Integration; standard scores with mean of 100, standard deviation of 15 |
Baseline to 16 weeks versus 16 weeks to 32 weeks
|
|
Difference in Mean Change in Pediatric Eye Questionnaire (PedEyeQ)
Tidsramme: Baseline to 16 weeks versus 16 weeks to 32 weeks
|
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) |
Baseline to 16 weeks versus 16 weeks to 32 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2023H0013
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