Zhu, Yanling
Mai, Yongjian
Wang, Yongyi
Huang, Ting
Huang, Jingxia
Lin, Yiquan
Zhao, Dongsheng
Gan, Xiaoliang
Article History
Received: 26 December 2024
Accepted: 22 March 2026
First Online: 2 April 2026
Declarations
:
: The first protocol (version 5.0) has received ethical approval from the IRB of Zhongshan Ophthalmic Center, Sun Yat-sen University (2024KYPJ108) on Sep 30, 2024. In the second protocol (version 6.0), the primary outcome was revised from the incidence of minor PRAEs to the incidence of PRAEs (including both minor and major AEs), and also, the sample size was increased, which was approved by the local Ethics Committee (2024KYPJ108-2) on Dec 10, 2024. The trial has been registered at ClinicalTrials.gov (NCT06624696). Prior to participation, legal guardians of the participants will provide informed consent. Results will be disseminated via an international peer-reviewed publication.
: Not applicable.
: None declared.