Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06372548
Other study ID # NEADS0004
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2023
Est. completion date August 1, 2024

Study information

Verified date April 2024
Source Shanghai Jiao Tong University School of Medicine
Contact Zhao Liu, prof
Phone +8618901626266
Email hotlz@sjtu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A gamification product was developed to guide children with amblyopia to develop rehabilitation training habits by combining cognitive evaluation theory and occlusion therapy. A randomized controlled trial was conducted to examine the ease of use, acceptability and treatment compliance of the game.


Description:

The experimental group was subjected to a 20-minute daily, 4-week intervention experiment, which included a story background on the start page, eye patches to be put on according to the guidelines, fine eye training, and visual stimulation training, with short breaks between the different modes. The control group was given an experimental intervention using a competing product, with the same duration and format as the experimental group. After completion of the intervention, the participating children completed the MMAS-8 adherence scale with the help of their parents.


Recruitment information / eligibility

Status Recruiting
Enrollment 34
Est. completion date August 1, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 7 Years to 10 Years
Eligibility Inclusion Criteria: - Diagnosis of amblyopia (including refractive amblyopia, strabismic amblyopia and mixed). - The child has no significant IQ deficits and has no difficulty communicating with others. - The children's teachers and parents gave their informed consent to participate in the experiment. The informed consent form was signed by the parents and is shown in the Appendix. Exclusion Criteria: - Severe amblyopia. - Suffering from other psychological or physical disorders. - Parents did not agree to sign the informed consent form or the child was not willing to participate in this experiment.

Study Design


Intervention

Device:
Find You! Cure My Animal Friends
Introduced cognitive evaluation theory combined with masking therapy to develop a gamified product that guides amblyopic children to develop habits for the purpose of rehabilitation training.
DuoBao Vision Training System
This is a visual training app where participants are required to complete several training tasks.

Locations

Country Name City State
China Shanghai Jiao Tong University Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Zhu Dian

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 8-Item Morisky Medication Adherence Scale (MMAS-8): A patient's adherence to therapy can be evaluated using the eight-question Morisky Medication Adherence Scale-8 (MMAS-8).The total score of the MMAS-8 scale is the sum of the scores of the above 8 questions, and the score range is 0~8. Higher scores indicate better medication adherence. 8 indicates good adherence; 6~7 indicates moderate adherence; <6 indicates poor adherence. baseline and study completion (after 8 weeks)
Secondary User Experience Questionnaire (UEQ) Enabling prompt and accurate user experience measurement is the primary goal of the UEQ.UEQ was administered post-experiment to swiftly and accurately measure user experience. Covering 26 items across six domains, UEQ evaluated the impact of the amblyopia rehabilitation training product on both children and their parents. Due to its language complexity, the questionnaire was completed with parental assistance.1 for disagree, 7 for strongly agree study completion (after 8 weeks)
See also
  Status Clinical Trial Phase
Recruiting NCT04238065 - A Clinical Trial of Caterna Virtual Reality Facilitating Treatment in Children With Amblyopia N/A
Completed NCT04432181 - Comparison of Deviation Types Among Astigmatic Children With Or Without Amblyopia
Terminated NCT02767856 - Regimens of Intermittent Occlusion Therapy for Amblyopia in Children N/A
Completed NCT02458846 - Efficacy of Visual Screening in Ontario N/A
Completed NCT01190813 - Levodopa for the Treatment of Residual Amblyopia Phase 3
Completed NCT01109459 - Multimodal Physician Intervention to Detect Amblyopia N/A
Completed NCT04313257 - Monocular Action Video Game Treatment of Amblyopia N/A
Completed NCT04315649 - Effect of 3D Movie Viewing on Stereopsis in Strabismus and / or Anisometropic Amblyops N/A
Completed NCT05223153 - OCT-A and Amblyopia
Recruiting NCT05522972 - Establishing New Treatment Approaches for Amblyopia: Perceptual Learning and Video Games N/A
Completed NCT01430247 - Vision Screening for the Detection of Amblyopia N/A
Completed NCT02200211 - Study of Binocular Computer Activities for Treatment of Amblyopia N/A
Recruiting NCT06429280 - Clinical Data Registry of Amblyopia Patients on Luminopia Treatment
Withdrawn NCT04959422 - Assuring Ophthalmologic Follow up N/A
Active, not recruiting NCT05612568 - 5 Years of Eye Screening for ARF in Children Aged <3 Years in Flanders
Recruiting NCT03655912 - Binocular Visual Therapy and Video Games for Amblyopia Treatment. N/A
Recruiting NCT06150391 - Evaluation of Amblyopia Protocols Using a Dichoptic Gabor Videogame Program N/A
Completed NCT03754153 - Binocularly Balanced Viewing Study N/A
Terminated NCT02246556 - Dichoptic Virtual Reality Therapy for Amblyopia in Adults Phase 1
Withdrawn NCT02594358 - Caffeine in Amblyopia Study Phase 1/Phase 2