Strabismus in children and adolescents
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Orthotopic subjects: 1. Age between 6-12 years old, male or female, eye position is positive; 2. Binocular uncorrected visual acuity of children aged 6 to 7 years old >=0.7; Or children over 8 years old >=0.8; 3. The spherical equivalent (SE) was > -0.50D and =0.7 for children aged 6-7 years; Or >=0.8 for children aged over 8 years; 4. The spherical equivalent (SE) of binocular refraction after mydriasis was > -0.50D, and < +0.50D; 5. There were no other organic diseases affecting visual acuity in both eyes, excluding form-deprivation factors (corneal leucoma, congenital cataract, complete ptosis); 6. Informed consent, and voluntarily sign the informed consent, in line with ethical norms; Informed consent was obtained in accordance with the GCP.
Exclusion criteria
Exclusion criteria: 1. Participants with previous strabismus surgery; 2. Organic eye diseases that can cause form deprivation, such as corneal leucoma, congenital cataract, and complete ptosis; 3. Loss to follow-up due to other lesions that could reduce or complicate enrollment according to the investigator's judgment; 4. Persons with mental or legal disabilities; 5. Participants taking part in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Oxyhemoglobin;Deoxyhemoglobin;Total Oxyhemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Degree of deviation;Degree of limitation of eye movement;Stereoscopic vision;Visual acuity;Ocular accommodation;Safety indicators (physical examination, vital signs, adverse events); | — |
Countries
China
Contacts
Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine