Clinical trials

Primary objective: • To evaluate the change in aqueous humor vascular endothelial growth factor A (VEGF-A) levels after 2 months of initial treatment with 8 mg Aflibercept in treatment-naïve nAMD patients. Secondary objectives: • To assess the efficacy, safety, and biomarker changes of 8 mg Aflibercept using a modified fixed-interval dosing regimen over 12 months in treatment-naïve nAMD patients.

Different myopia control interventions have certain effects on ocular asthenopia in children and adolescents. As children and adolescents are in a critical period of visual development, the presence of asthenopia may lead to an earlier onset and increased prevalence of a range of chronic eye diseases and retinal disorders, thereby affecting their physical and mental health as well as future development. However, existing studies have mostly focused on single interventions, lacking a systematic comparison of the effects of multiple myopia control approaches on asthenopia. Therefore, the present study aims to investigate, through a cross-sectional survey, the impact of various myopia control interventions-including conventional spectacles, defocus-inducing spectacles, orthokeratology, low-concentration atropine, red-light therapy, and combined multi-intervention strategies-on asthenopia, to assess the prevalence and severity of asthenopia among users of different interventions, and to compare the differences in their effects on asthenopia. This will provide evidence-based support for the selection of individualised correction strategies in clinical practice and contribute to advancing clinical research on asthenopia in children and adolescents.

Myopia has emerged as a significant concern impacting the visual health of children and adolescents on a global scale. According to research conducted by Holden BA et al., it is projected that by the year 2050, the worldwide prevalence of myopia and high myopia will experience a substantial increase, affecting approximately 5 billion and 1 billion individuals, respectively, with particularly high prevalence rates observed in East Asia\[1\]. The persistent rise in myopia incidence, coupled with the escalation of complications associated with high myopia, is anticipated to exert complex socio-economic repercussions \[2\]. Consequently, the prevention of myopia onset and the management of axial length elongation have become critically important \[3\]. Orthokeratology (Ortho-K) is a procedure that involves the overnight application of specially designed reverse geometry rigid gas permeable contact lenses to achieve temporary corneal reshaping and reduce myopia during the day\[4,5\]. In children with mild to moderate myopia, Ortho-K has demonstrated visual correction efficacy ranging from 80% to 92%\[6,7\]. Nonetheless, its efficacy in controlling myopia progression may not match its corrective efficacy. The therapeutic effect of Ortho-K in decelerating axial elongation is reported to range from 43% to 63%. Despite the use of Ortho-K, approximately 15% of children continue to exhibit rapid axial elongation exceeding 0.36 mm per year.\[8,9\]. In recent years, adjunctive interventions such as low-concentration atropine eye drops, modification of the back optical zone diameter (BOZD) of orthokeratology (Ortho-K) lenses, and low-level red-light therapy (RLRL) have been proposed to augment the myopia control efficacy of Ortho-K. Zhao et al. \[10\] reported that after one year of treatment with either atropine orthokeratology (AOK) or Ortho-K lenses in children aged 5-14 years, the axial length (AL) increased by 0.14 mm and 0.29 mm, respectively. Another study involving children aged 8-12 years \[11\] demonstrated that after one year of treatment, the AOK group exhibited a 17% reduction in AL growth (0.20 mm vs. 0.24 mm). Research conducted by Xiong et al. \[12\] indicated that for children whose eyes elongated by at least 0.50 mm within one year of Ortho-K wear, the combination of RLRL therapy with Ortho-K significantly reduced axial elongation compared to Ortho-K alone. Additional studies have suggested that decreasing the BOZD can enhance the extent and degree of mid-peripheral corneal steepening, thereby decelerating axial elongation \[13-15\]. Most existing studies primarily compare a single intervention against a control group, thereby lacking direct "head-to-head" comparisons. Traditional meta-analyses are limited to comparing two interventions at a time and often fail to assess multiple treatments concurrently. Consequently, most meta-analyses offer only statistical insights into the efficacy of individual interventions. Clinically, it is common to combine two or more interventions to treat myopia, particularly in cases of rapidly progressive myopia. Previous research has indicated that combined interventions may have additive effects in the prevention and control of myopia; however, these findings require further empirical validation. This study employs a retrospective approach to evaluate the efficacy of various treatment strategies in managing axial elongation in children aged 8-12 years who experience rapid axial progression following Ortho-K lens wear. The objective is to provide a scientific foundation for the development of personalized myopia control plans.

A prospective multicenter study design was adopted. Children aged 6-9 years with premyopia who met the criteria were screened and administered after completion of baseline assessment. Phase I: 0-24 weeks (0-6M). 0.01% atropine eye drops, once daily, at point in both eyes. Phase II: 24-48 weeks (6-12M). According to the rate of myopia progression at 0-24 weeks (6M), the atropine concentration was increased in steps; once daily, at point in both eyes. Group A: ( SE ≤ 0.25D), continued to maintain 0.01% atropine. Group B: (0.25D \< SE ≤ 0.375D), converted to 0.02% atropine. Group C: ( SE \> 0.375D), converted to 0.04% atropine. Followed up 5 times (0, 3, 6, 9, 12 months), collected refractive, ocular axis, intraocular pressure and other data, and recorded adverse events and cost information synchronously. Statistical analysis was carried out by covariance analysis and multivariate model, and pharmacoeconomic evaluation and drug proportion analysis were carried out.

Diabetic macular edema (DME) is the main cause of vision loss in patients with diabetes. At present, anti-vascular endothelial growth factor (VEGF) intravitreal injection is the first-line therapy for DME, nevertheless, some patients do not respond well to anti-VEGF agents and often require multiple injections, which increases the psychological and economic burden of patients. Microinvasive pars plana vitrectomy (PPV) has been proven to be safe and effective for refractory DME. However, there are few studies on treatment-naïve DME. The purpose of this study is to explore whether early PPV combined with internal limiting membrane (ILM) peeling can reduce the treatment burden of DME patients, prevent vision loss, and maintain long-term stabilization of diabetic retinopathy.