Skip to content

A Clinical Trial to Assess the Effectiveness of Vision Planet Training System for Amblyopia Treatment in Children

A Clinical Trial to Assess the Effectiveness of Vision Planet Training System for Amblyopia Treatment in Children

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072066
Enrollment
Unknown
Registered
2023-06-01
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

Amblyopia

Interventions

Self-control group: Vision Planet binocular vision training

Sponsors

Eye and ENT Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1. The age is 4 years old (inclusive) to 7 years old (exclusive), male or female; 2. Amblyopia (previously treated or untreated) associated with strabismus, anisometropia, or both; 3. Refractive error correction is mandatory if any of the following are true (based on cycloplegic dilated refraction results completed within the past 6 months): (1) Hyperopia: hyperopia with spherical equivalent (SE) 2.50D or above (>= +2.50 D); (2) Astigmatism: 1.00D and above astigmatism (>= 1.00 D); (3) Anisometropia: Anisometropia with spherical equivalent power exceeding 0.50D (> 0.50 D); 4.Vision: (1) The visual acuity of the amblyopic eye is 20/32 to 20/200 (inclusive); (2) The best corrected visual acuity of the dominant eye/dominant eye meets the following criteria: 1) 4 years old: Lea symbol eye chart examination shows 20/40 or higher (according to the ATS inspection process); 2) 5 years old and above, eyesight should be 20/32 or higher: = 2 lines (according to the Lea symbol eye chart inspection process of ATS); 5. Forgo other treatments voluntarily during the study period, voluntarily comply with the treatment methods specified in this protocol, and cooperate with the physician with the physician's examination. 6. Parents and participants understand and are willing to follow the study procedures and Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Myopic patients; 2. Subjects with a history of intraocular surgery, refractive surgery, or a combination of organic eye disease related to vision loss, or, according to the investigator's judgment, any other potential reasons that may lead to a decrease in BCVA; 3. Treatment history of low compliance with amblyopia treatment informally assessed by the investigator; 4. History of light-induced epilepsy; Wear rigid breathable contact lenses; Any reported ocular anatomical abnormalities (for example, partial opacity of the lens, myelinated nerve fibers, etc.); 5. Subjects' participation in other clinical studies within 3 months; 6. The presence of other conditions such as subjects not wearing glasses and not being able to cooperate in completing the test, as assessed by the investigator; 7. Any situation that may prevent the subject from completing the daily continuous 20-60 minutes of training in front of the close-up monitor. For example, the subject is unable to pass the Vision Planet suitability test-own or with guidance from others; 8. Always see strabismus with near eye deviation >= 10? (measured by PACT). 9. Subjects had paracentric gaze.

Design outcomes

Primary

MeasureTime frame
Best Corrected Visual Acuity (distance);Best Corrected Visual Acuity (near);

Secondary

MeasureTime frame
Stereopsis;

Countries

China

Contacts

Public ContactRui Liu

Eye and ENT Hospital of Fudan University

LRATB1@ALIYUN.COM+86 137 6406 4088

Outcome results

None listed

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