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Clinical safety study of aberration-regulating amblyopia treatment device

Clinical safety study of aberration-regulating amblyopia treatment device

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114095
Enrollment
Unknown
Registered
2025-12-08
Start date
2023-07-17
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Amblyopia

Interventions

minimum training duration group:accumulated training for 6 hours
target training duration group:accumulated training for 10 hours
maximal tolerable dose group:accumulated training for 14 hours

Sponsors

Department of Ophthalmology, West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 30 Years

Inclusion criteria

Inclusion criteria: 1. 18-30 years of age, regardless of sex; 2. clear refractive media in the examined eye; 3. no nystagmus in the examined eye, with good fixation ability; 4. Refractive amblyopia in one eye; 5. no other amblyopia treatment (e.g., masking, atropine, Bangerter's suppression film, binocular vision training, etc.) in the two weeks prior to the start of the trial; 6. Require corrective spectacles for at least 16 weeks or stable corrected visual acuity. Stable visual acuity is defined as a change in visual acuity of = 2 lines; 8. Subjects are able to understand and perform the training, have the ability to accurately judge the pattern after familiarising themselves with the instrument, and voluntarily participate and follow up; 9. subjects are able to understand and perform the visual task in the MRI scanning environment, have the ability to accurately judge patterns after familiarisation with the task operation, and volunteer to participate.

Exclusion criteria

Exclusion criteria: 1. Corrective lenses with additional prisms at enrolment; 2. History of intraocular surgery or refractive surgery; 3. Receipt of any amblyopia treatment within the preceding 2 weeks, including occlusion therapy, atropine, Bangerter suppression film, or binocular vision training. Prior amblyopia treatment history (regardless of modality) is permissible provided a washout period of at least 2 weeks has been achieved prior to enrolment; 4. Any ocular complications diagnosed within the past 7 months that may impair visual acuity; 5. Down syndrome or cerebral palsy; 6. Severe developmental delays, such as language or reading disorders, judged by the investigator to potentially interfere with treatment or examinations; 7. History of head trauma complicated by other psychiatric or neurological disorders; 8. Metabolic disorders such as diabetes mellitus or hyperthyroidism; 9. Organ diseases affecting the cardiovascular, hepatic, renal, pulmonary systems, etc.; 10. History of alcohol or substance abuse; 11. Contraindications for magnetic resonance imaging (MRI), such as claustrophobia; 12. Any circumstances where the investigator deems the patient unsuitable for participation in this study for safety reasons or in the patient's best interests.

Design outcomes

Primary

MeasureTime frame
The incidence and severity of dose-limiting toxicity;The extraocular and anterior segment of the eye;fundus examination;

Secondary

MeasureTime frame
best corrected visual acuity;other visual function indicators;

Countries

China

Contacts

Public ContactLiu Longqian; Liao meng

Department of Ophthalmology, West China Hospital, Sichuan University

liaomeng_213@hotmail.com+86 135 1817 2174

Outcome results

None listed

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