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Randomized, controlled, single-blind, single-center clinical trial of efficacy and safety of amblyopia treatment software based on eye dominance shift in the treatment of children with anisometric amblyopia

Randomized, controlled, single-blind, single-center clinical trial of efficacy and safety of amblyopia treatment software based on eye dominance shift in the treatment of children with anisometric amblyopia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100071
Enrollment
Unknown
Registered
2025-04-02
Start date
2025-04-21
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Amblyopia

Interventions

Experiment group:Visual training method of asynchronously receiving image stimulation in both eyes.
Control group:Visual training method of synchronously receiving image stimulation in both eyes.

Sponsors

Eye and ENT Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 8 Years

Inclusion criteria

Inclusion criteria: 1. Age 4-8 years old (including 4 and 8 years old), gender is not limited; 2. Patients diagnosed with non-myopic anisometropic amblyopia on an outpatient basis; 3. The difference in diopter power of the spherical lens is 1.50DS or the difference in the diopter power of the cylindrical lens is 1.00DC; 4. Poor binocular visual acuity>=0.2 (>=0.2 logMAR); 5. According to the visual acuity of amblyopia, it is classified as mild (0.5~0.8), moderate (0.2~0.5) or severe (<0.2) amblyopia; 6. Have had their visual acuity corrected by optical corrective glasses for at least three months; 7. No organic lesions of both eyes were found in clinical examination; 8. Subjects voluntarily participate in the trial and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Clinical examination found organic lesions in both eyes; 2. Participant has any acute or chronic disease or hereditary visual system disease; 3. Those who are known to be allergic to mydriatic drugs such as atropine; 4. Those with a known history of ocular surgery; 5. Known combinators with other types of amblyopia; 6. Other conditions that the investigator deems inappropriate to participate in clinical trials.

Design outcomes

Primary

MeasureTime frame
Corrected visual acuity;

Secondary

MeasureTime frame
Visual function;Spherical equivalent;Axial length;Intraocular pressure;

Countries

China

Contacts

Public ContactXiaomei Qu

Eye and ENT Hospital of Fudan University

quxiaomei2002@126.com+86 136 5180 3988

Outcome results

None listed

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