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Efficacy and safety of dichoptic therapy in improving binocular vision dysfunction

Efficacy and safety of dichoptic therapy in improving binocular vision dysfunction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063361
Enrollment
Unknown
Registered
2022-09-05
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

amblyopia,strabismus

Interventions

Experimental group:Using visual function training treatment software (Model: SJ-HRS2020)
Control group:Refractive correction will be performed and cover up if needed

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 18 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for amblyopia patients 1. Age 6-12 years old (including 6 and 12 years old), both sexes; 2. According to the Chinese medical association branch of ophthalmology strabismus with the pediatric ophthalmology group children amblyopia prevention expert consensus of the People's Republic of China (2021) diagnosed with mild-to-moderate reduced vision, namely in the visual development, because the monocular strabismus, anisometropia not correct, the height of the uncorrected refractive errors, monocular or binocular best corrected visual acuity caused by sleep deprivation is lower than the corresponding age vision for amblyopia; Or the visual acuity difference of two or more lines, the lower visual acuity is amblyopia. According to the law of visual acuity development of children, the lower limit of normal visual acuity of children aged 3-5 years was 0.5, and the lower limit of normal visual acuity of children aged 6 years and above was 0.7. The best corrected visual acuity of both eyes was >= 0.2. 3. Patients with ametropic amblyopia and anisometropic amblyopia were required to wear corrective glasses for more than 3 months before enrollment. In form deprivation amblyopia, it is necessary to remove the factors of form deprivation (such as congenital cataract, ptosis, etc.). Patients with strabismic amblyopia were enrolled after strabismic surgery if surgery was required. 4. The guardian of the subject can understand the purpose of the trial and sign the informed consent. The subject can cooperate with the treatment and related ophthalmic examination Inclusion criteria for patients after strabismus surgery 1. Ages 6 to 18 (including 6 and 18), both sexes; 2. Postoperative concomitant strabismus; 3. One month after the operation, the proximal and distal eye position was = 0.8; 5. If you have refractive error, wear best corrected glasses for more than 1 week; 6. No visual function training in any other form.

Exclusion criteria

Exclusion criteria: Exclusion criteria for amblyopia 1. Subjects with tumor, heart disease, hypertension (blood pressure of children aged 4 to 6 years; 110/70 mm Hg, blood pressure in children 7 to 12 years old. 120/80 mm Hg), epilepsy; 2. The subject has an implanted electronic device, such as a pacemaker; 3. The subject has suffered from mental illness; 4. The subject has photophobia and tears caused by keratitis, conjunctivitis, internal trichiasis and other diseases at any time; 5. Subject suffers from vertigo, fear of heights or brain trauma; 6. The subject's eyes have congenital glaucoma, congenital ptosis, dacryocystitis, trauma and other organic lesions; 7. Subjects who had received cover therapy or therapeutic apparatus for amblyopia treatment within 4 weeks before enrollment; 8. Subjects participated in other clinical trials 4 weeks before enrollment; 9. Other conditions, such as severe heart, liver and kidney disease, under which the investigator considers that the patient should not participate in the trial for safety reasons or in the interest of the patient. Exclusion criteria for patients after strabismus surgery 1. Vertical strabismus > 5?; 2. Diplopia occurred at the reexamination one month after operation 3. Limited eye movement; 4. The subject has tumor, heart disease, hypertension and epilepsy; 5. The subject has an implanted electronic device, such as a pacemaker; 6. The subject has suffered from mental illness; 7. The subject has photophobia and tears caused by keratitis, conjunctivitis, internal trichiasis and other diseases at any time; 8. Subject suffers from vertigo, fear of heights or brain trauma; 9. The subject's eyes have organic lesions such as congenital glaucoma, congenital ptosis, dacryocystitis and trauma; 10. Other conditions, such as severe heart, liver and kidney disease, in which the investigator considers that the patient should not participate in the trial for safety reasons or in the interest of the patient.

Design outcomes

Primary

MeasureTime frame
The total effective rate is 6 months;Best corrected visual acuity;

Secondary

MeasureTime frame
Near stereopsis;Tertiary visual function;

Countries

China

Contacts

Public ContactLiu Longqian

West China Hospital of Sichuan University

liulq@scu.edu.cn+86 18980601759

Outcome results

None listed

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