Intravitreal drug injection is a treatment for common chronic fundus diseases such as age-related macular degeneration and diabetic retinopathy. The “14th Five-Year” National Eye Health Plan (2021-2025) recommends focusing on fundus diseases and improve the management mode of patients with chronic eye diseases. Therefore, it is imperative to explore how to further optimize the service process of intravitreal injection under the premise of guaranteeing patients' medical safety, to promote medical service efficiency and standardized management level and improve the medical experience of patients. Based on the quality control standard of vitreous cavity injection for retinopathy in China, Chinese fundus disease and related field experts developed the present expert consensus on the establishment of a one-stop intravitreal injection model and the management of its organization after a serious, comprehensive, and complete discussion, focusing on a standardized operation process, quality control, and safety management, providing more references for establishing a suitable intravitreal injection management model for ophthalmology and promoting the development of diagnostic and treatment models for fundus disease in China.
Clinical trials are the most reliable means for scientifically rigorous evaluation of the efficacy and safety of drugs, and are the most crucial part receiving the most investment in development and innovation in the pharmaceutical industry. In recent years, the nation has formulated a set of policies and guiding principles to encourage pharmaceutical innovation, promote the independent innovation of China’s pharmaceutical industry and enhance clinical trial capacity. To further improve Chinese researchers’ ability to perform clinical trials, the National Clinical Research Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and the National Center for Cardiovascular Diseases invited a multi-disciplinary team of experts from various areas including clinical trial methodology and supervision to work on this consensus. In view of the common concern and puzzles regarding the issues in clinical trials, such as recruitment and retention of participants, outcome selection, quality control, information technology application, and ethics in data security, the expert consensus is based on domestic and international guidelines, the latest advancement of clinical research, and the advice and opinions from national experts. It aims to provide reference information and guidance for clinical trial researchers, and serves as a reference for relevant authorities to formulate clinical trial management policies.
Glycogen storage disease type Ib (GSD Ib) is a rare disorder of glycogen metabolism, often complicated by neutropenia/neutrophil dysfunction, leading to recurrent infections and the development of inflammatory bowel disease (IBD), which severely impacts patients’ quality of life. Empagliflozin, an SGLT2 inhibitor, has demonstrated the ability to restore neutrophil counts and function, thereby improving the immunodeficiency state in GSD Ib patients. This consensus aims to provide clinical practice recommendations for the use of empagliflozin in GSD Ib based on current evidence and expert experience. The purpose of this document is to outline these key points and offer guidance for the clinical application of empagliflozin in GSD Ib.
In the context of the rapid development of contemporary medical industry and the unbalanced development of various subspecialties, expert consensus plays an extremely important role in guiding clinical practice and improving the quality of medical care. However, there are some deficiencies and limitations in the formation process and final report of the expert consensus. Therefore, this paper summarizes and reviews the definition, applications, and functions of expert consensus and the new progress of expert consensus formation methods by fully reviewing the literature, and puts forward the prospect. The purpose is to provide a reference for the production and application of expert consensus related to medical care, improve the outcomes of medical care, and upgrade the quality and level of medical services.
Diabetic retinopathy is one of the microvascular complications of diabetes and a major cause of blindness in adults. Early screening is an effective way to reduce blindness caused by diabetic retinopathy. The diabetic retinopathy is one of the chronic retinal diseases highlighted in the “14th Five-Year” National Eye Health Plan (2021-2025). The establishment of effective and practical community screening model is a powerful guarantee to complete early screening. It is of great significance to standardize screening methods, screening personnel duties, equipment allocation, referral conditions and screening sustainability. Chinese fundus disease and related field experts developed the consensus through a serious, comprehensive, and complete discussion, to provide more reference for establishing a suitable community screening model of diabetic retinopathy and increasing the screening rate of diabetic retinopathy.
In recent years, anti-vascular endothelial growth factor (VEGF) therapy has become first line treatment for a variety of clinical conditions, including wet age related macular degeneration, macular edema secondary to retinal vein occlusion, diabetic macular edema and proliferative diabetic retinopathy. With the successive launch of new formulations such as high-dose anti-VEGF drugs and gene therapy in China, sterile intraocular inflammation (SIOI) after intraocular drug delivery has gradually come into public view and warranted attention. On the other hand, a variety of drugs that have been used in ophthalmic clinics for years, including prophylactic anti-infective drugs (such as vancomycin) and glucocorticoids (such as dexamethasone implants), have also been reported of SIOI occurrence. To avoid and alleviate the negative impact of SIOI on the visual function of the affected eyes, a systematic and standardized SIOI management system is urgently needed. For this reason, the Fundus Disease Group of Ophthalmological Society of Chinese Medical Association, Fundus Disease Committee of Ophthalmologist Branch of Chinese Medical Doctor Association, and Expert Group of Expert consensus for the diagnosis and treatment of sterile intraocular inflammation after intraocular drug delivery (2025) put forward recommended opinions on seven key clinical issues. Based on the latest evidence based medical evidence, combined with international guidelines/consensuses and the current situation of social and economic development in China, they made recommendations on aspects of SIOI, including the incidence and timing, clinical manifestations, related factors and population identification, perioperative monitoring measures, and intervention strategies and prognosis after the occurrence of SIOI, thus forming the Expert consensus for the diagnosis and treatment of sterile intraocular inflammation after intraocular drug delivery (2025). The formulation of this consensus aims to enhance the awareness and understanding of SIOI among ophthalmologists specializing in retinal diseases, provide evidence-based guidance and decision-making references for the early identification and standardized management of SIOI in clinical practice, and further improve the quality control system of intraocular injection therapy in China, thereby ensuring patient safety.
Choroideremia (CHM) is a rare X-linked recessive genetic inherited degeneration. Affected males present with progressively worsening night blindness, visual field loss, and decreased central vision, which can cause blindness in middle age. Although female carriers typically exhibit mild symptoms, it is essential to understand their clinical features for early diagnosis of patients as well as genetic counseling of family members. The pathogenesis of CHM remains incompletely understood, and currently there is no approved effective treatment. To enhance clinicians’ comprehension of CHM and establish standardized clinical approaches to its diagnosis and management, the Chinese Hereditary Ocular Disease Diagnosis and Treatment Group and the Chinese Hereditary Ocular Disease Alliance assembled authoritative experts, through in-depth discussions, formed China's standardized recommedations for the on clinical diagnosis and treatment of CHM. The purpose of this advice is to provide a standardized diagnostic framework, monitoring indicators, and an integrated management strategy for clinicians to use in practice, thereby optimizing the care and genetic guidance for patients with CHM.
Anti-tumor necrosis factor-α monoclonal antibody agents have been widely applied in the management of autoimmune diseases. Among them, Adalimumab and Infliximab have been used for years in clinical practice in treating non-infectious uveitis and achieved satisfactory effects and safety. However, no guideline or expert consensus for their usage is available in China currently. It hopefully promotes standardized clinical application of anti-tumor necrosis factor -α monoclonal antibody in treating non-infectious uveitis, together with other senior experts in uveitis, the Ocular Immunology Group of Immunology and Rheumatology Academy in Cross-Straits Medicine Exchange Association form this evidence-based recommendations for clinicians’ reference.
With the advancement of research on rare ocular diseases such as inherited retinal dystrophy (IRD) has advanced in recent years, especially breakthroughs in therapeutic approaches represented by cell and gene therapy, potential intervention strategies have emerged for these conditions. Establishing standardized endpoints and evaluation methods for visual function in patients with IRD has become crucial for assessing disease progression, safety, and therapeutic efficacy of innovative treatments. Best corrected visual acuity (BCVA) is widely recognized as one of the primary endpoints for assessing visual function. However, for IRD patients with severe rod photoreceptor dysfunction, who often present with profound low vision or even legal blindness, the applicability of BCVA as a traditional visual function indicator is limited. The multi-luminance mobility test (MLMT) has emerged as a functional visual assessment tool that evaluates the ability to navigate obstacle courses under varying illumination levels. By establishing graded evaluation standards, MLMT objectively quantifies the impact of lighting conditions on patients’ nobility and spatial orientation, providing a novel quantitative tool for assessing visual function in IRD clinical trials. Currently, there is a lack of unified and standardized guidelines for the use of MLMT in China, posing challenges to its implementation in practical clinical research. To address this, Ocular Fundus Disease Society of Chinese Medical Association and Chinese Medical Doctor Association convened a multidisciplinary team comprising clinical experts in genetic retinal diseases, statisticians, and optical specialists to investigate the current applications and technical characteristics of MLMT, ultimately formulating consensus recommendations for its use as a clinical trial endpoint for IRD gene therapies. This consensus aims to provide a set of MLMT operating norms applicable to China's national conditions, guide clinical practice and research in ophthalmology and related disciplines, and promote the standardization process of IRD clinical trials in China, so as to better serve the IRD patient population and promote the development of related fields.
Maculopathy caused by various fundus diseases in the late stage is a common cause of low vision. Medical technology is difficult to reverse the loss of macular function currently, so interventions that help improve the visual system, utilize residual visual function, and improve quality of life deserve attention. Damage to the fovea of the macula does not mean that the entire retinal function is impaired. There may be one or more retinal regions adjacent to the fovea that can serve as a fixation center. It is possible to form stable paracentral fixation, complete functional remodeling of the visual system, and effectively utilize residual visual function by taking appropriate training on these potential paracentral fixation points for most patients. In 2021, a clinical guideline has been published for low vision rehabilitation in China. In order to strengthen the precise management of diseases and develop a standard operating procedure for visual training specifically for patients with low vision due to macular disease, the National Clinical Research Center for Eye Diseases initiated and organized relevant domestic experts, utilizing the latest research experience at home and abroad, and through repeated discussions, this consensus (International Practice Guideline Registration Number: PREPARE-2023CN199) was formed as a reference for ophthalmologists, optometrists and rehabilitation physicians in their clinical research and practice.