A randomized, double-blind, controlled clinical trial was conducted to evaluate the efficacy and safety of nebulized bedazol eye drops in the control of pseudmyopia in children and adolescents

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2026
INTERVENTION: Intervention Group:Daily wear of orthoptic frame glasses is required, along with eye ultrasonic nebulization therapy using 2 ml of dibazol eye drops diluted in saline to a total volume of 30 ml; the nebulization session lasts 15 minutes and is performed once a day, between 18:00 and 22:00. This treatment is continued without interruption for a total of si Xmonths.;Control group:Daily wear of orthoptic frame glasses is required; eye ultrasonic nebulization therapy is carried out using a solution prepared by diluting 2 ml of dibazol in sterile saline to a total volume of 30 ml. The nebulization session lasts 15 minutes and is performed once a day, between 18:00 and 22:00. This treatment is continued without interruption for a total of si Xmonths.; CONDITION: Pseudomyopia PRIMARY OUTCOME: Myopia progression (measured by refraction);Change of spherical equivalent before and after mydriasis.; SECONDARY OUTCOME: Adverse events: recorded at any time;Changes in axial length;;Changes in choroidal thickness;;Changes in choroidal blood flow;Change in amplitude of accommodation;Adjust lag changes;Adjust sensitivity changes;Pupil examination;;Intraocular pressure monitoring;;Fluorescein corneal staining;;Slit‐lamp examination;; INCLUSION CRITERIA: 1.Age of 8‐12 years old (including 8 years old and 12 years old); 2.The spherical equivalent after cycloplegia ranged from +1.50D to ‐4.00D; 3.Diopter change after mydriasis; 4.The annual increase of myopia was not less than ‐0.50D; 5.The best corrected visual acuity of both eyes was 4.9 or better; 6.Anisometropia less than 2.00D; 7.Accommodation lag > +0.5D; 8.Binocular accommodative sensitivity less than 8 cycles /min; 9.Those who have obtained informed consent from legal guardians and children and can carry out the experiment in accordance with the requirements of the protocol.
Epistemonikos ID: 9c54a279d8a27cbd5c8ea2f7e44145c733b7fd37
First added on: Oct 08, 2026