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Optimized patching therapy with reduced dose plus atropine for moderate to severe pediatric amblyopia

Optimized patching therapy with reduced dose plus atropine for moderate to severe pediatric amblyopia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097295
Enrollment
Unknown
Registered
2025-02-17
Start date
2025-03-01
Completion date
Unknown
Last updated
2025-02-24

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

Conditions

Amblyopia

Interventions

Experimental group:2 hours of patching combined with atropine daily
Control group:6 hours of patching daily

Sponsors

Eye & ENT Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 8 Years

Inclusion criteria

Inclusion criteria: 1. Age: 3-8 years old; 2. Wear glasses for at least 4 weeks before enrollment (refractive correction alone can obtain different degrees of visual acuity improvement, and too short wearing time may be mixed with refractive correction factors when evaluating the treatment effect, but the latest research found early.) Covering can obtain a better treatment effect, so the time of wearing glasses before enrollment is 4 weeks; 3. BCVA=2 rows; 4. Strabismus, anisometropia or mixed amblyopia: 5. Diagnostic criteria for strabismus: strabismus in distant or near vision with or without glasses, or history of previous strabismus surgery; 6. Diagnostic criteria for anisometropia: binocular spherical equivalence (SE) difference >=1.00D, or astigmatism difference >=1.50D; 7. Mixing: the above two situations exist at the same time; 8. Except for refractive correction and strabismus surgery, have not received other amblyopia treatment; 9. The subject's parents or legal guardians have signed the informed consent form and are willing to undergo randomization and regular follow-up.

Exclusion criteria

Exclusion criteria: 1. Myopia; 2. In addition to strabismus and anisometropia, there are other eye diseases that affect vision; 3. History of intraocular surgery; 4. Allergy to atropine or other cycloplegic agents; 5. Presence of contraindications to atropine; 6. Down syndrome or obvious developmental delay and inability to cooperate with the examination; 7. Birth < 34 weeks or birth weight < 1500 grams; 8. Participate in other clinical studies.

Design outcomes

Primary

MeasureTime frame
Best corrected visual acuity of the amblyopic eye;

Secondary

MeasureTime frame
Stereoacuity;

Countries

China

Contacts

Public ContactYao Jing, Zhao Chen

Eye & ENT Hospital, Fudan University

yaojingxiao@163.com+86 159 0079 1046

Outcome results

None listed

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