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A Clinical Trial of Virtual Reality Visual Function Training and Treatment Software for Children with Amblyopia

A Randomized, Multicenter, Clinical Control Study to Evaluate the Efficacy and Safety of DOBOSO Virtual Reality Facilitating Treatment Patients With Amblyopia in Children

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031517
Enrollment
Unknown
Registered
2020-04-03
Start date
2020-04-06
Completion date
Unknown
Last updated
2020-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amblyopia

Interventions

Control:Best optical correction with standard patch

Sponsors

The First Affiliated Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Patients from 4 to 12 years old (including 4 and 12 years old), regardless of gender; 2. According to the expert consensus on amblyopia diagnosis (2011) 1 of strabismus and pediatric ophthalmology group of Ophthalmology branch of Chinese Medical Association, the patients were diagnosed as amblyopia, that is, the best corrected vision of monocular or binocular caused by monocular strabismus, uncorrected anisometropia, high ametropia and form deprivation during visual development was lower than that of corresponding age, or the difference of binocular vision was 2 lines or more. The lower limit of normal visual acuity for children of different ages: the lower limit of normal visual acuity for children aged 4 to 5 years is 0.5, and the lower limit of normal visual acuity for children aged 6 and above is 0.7. 3. The guardian of the subject can understand the purpose of the test and is willing to sign the informed consent. 4. Subjects who can cooperate with treatment and related ophthalmic examination.

Exclusion criteria

Exclusion criteria: 1. Subjects with tumor, heart disease (blood pressure > 110 / 70 mmHg in 4-6 years old children, blood pressure > 120 / 80 mmHg in 7-12 years old children), hypertension and epilepsy; 2. Subjects with implanted electronic devices, such as pacemakers, etc.; 3. Subjects who had mental illness; 4. Any subject who suffers from photophobia and tears due to keratitis, conjunctivitis, and entropion; 5. Subjects with vertigo or acrophobia; 6. Subjects with congenital glaucoma, congenital ptosis, dacryocystitis, trauma and other organic diseases; 7. Subjects who have received the treatment of amblyopia by covering therapy or treatment instrument within 4 weeks before enrollment will not be included in the treatment of wearing corrective glasses and mydriasis; 8. Subjects who participated in other clinical trials 4 weeks before enrollment; 9. For safety reasons or the interests of patients, the clinician believes that other circumstances that should not participate in this trial, such as the subjects with serious heart, liver and kidney diseases.

Design outcomes

Primary

MeasureTime frame
Effectiveness of amblyopia treatment with VR;

Secondary

MeasureTime frame
Effectiveness of amblyopia treatment with VR;Effectiveness of amblyopia treatment with VR;Stereopsis: distance and near, respectively;Contrast sensitivity function (CSF);

Countries

China

Contacts

Public ContactLiu Hu

The First Affiliated Hospital of Nanjing Medical University

liuhu66@163.com+86 13952091066

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026