Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
Location status: Recruiting
NCT Number: NCT07472231
This project addresses the challenge of visual function intervention in children with monocular anisometropic amblyopia. It employs two innovatively designed digital games combined with occlusion therapy to conduct visual function training through parent-child interaction in home or multi-scenario environments. The study will compare this combined approach against traditional occlusion therapy alone, evaluating improvements in visual function, intrinsic motivation, and emotion regulation before and after the intervention. The research aims to promote the implementation and dissemination of personalized and engaging healthcare services. Ultimately, it seeks to establish a comprehensive visual function training product and service system suitable for daily use in home settings, with the goals of reducing medical anxiety in children and holistically enhancing treatment efficacy, training compliance, and overall clinical experience.
Interested in participating?
Request Info4 year–7 year
All sexes
Interventional
Not applicable
Shanghai, Shanghai Municipality, 200092, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The game designed for amblyopia training feature innovative designs.
The game designed for amblyopia training feature innovative designs.
Wear an eye patch on the sound eye side daily for 4 hours.
Time frame: 3 months after the first visit
Contrast sensitivity measured using the standard contrast sensitivity test;Stereopsis measured using the Titmus Fly Test;Simultaneous perception assessed using the Worth 4-dot test;Fusion ability assessed using the synoptophore with line fusion targets.
Time frame: 3 months after the first visit
Time frame: 3 months after the first visit
Functional vision assessed by Cardiff Visual Ability Questionnaire for Children (CVAQC). Total score ranges from 0 to 48. Higher scores indicate better outcome.
Time frame: 3 months after the first visit
Total score ranges from 0 to 50. Higher scores indicate greater levels of fear/anxiety.
Time frame: 3 months after the first visit
Total score ranges from 0 to 5. Higher scores indicate greater levels of anxiety.
Time frame: 3 months after the first visit
User experience assessed by Intrinsic Motivation Inventory (IMI). Total score ranges from 0 to 100. Higher scores indicate greater motivation.
Time frame: 3 months after the first visit
User experience assessed by Game Experience Questionnaire (GEQ). Total score ranges from 0 to 50. Higher scores indicate better game experience.
Contact information is provided by the study sponsor or research team.
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Other
An Exploratory Study on the Short-Term Additive Efficacy and User Experience of Innovative Gamified Intervention as an Adjunctive Therapy for Children With Monocular Anisometropic Amblyopia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07226141
Amblyopia, Amblyopia Strabismic
Boston, Massachusetts, United States
View Trial DetailsNCT07547670
Amblyopia, Amblyopia Strabismic
Murcia, Spain
View Trial DetailsNCT03655912
Amblyopia, Brain Diseases
Monterrey, Nuevo León, Mexico
View Trial DetailsNCT05439200
Amblyopia, Brain Diseases
Dallas, Texas, United States
View Trial Details