Objective:To develop an evaluation index system for the quality management process of investigator-initiated trials(IITs) in ophthalmology, providing a scientific tool and reference for improving clinical research quality and standardized management.Methods:Key quality management elements of ophthalmology IITs were identified through a literature review and experts interviews. A three-round Delphi consultation was conducted with experts from 16 provinces and municipalities in China who specialize in ophthalmic clinical research management. The importance of each index was scored, and weighting calculations were performed. Based on ranking and feasibility, a validated quality index system for ophthalmology IITs was established.Results:A three-tier index system was developed, comprising three first-level indicators (structure, process, and outcome), 15 secondary indicators, and 44 tertiary indicators. The expert authority coefficient was 0.87, and the response rates for the three Delphi rounds were 100%, 92.58%, and 100%, respectively. Among the first-level indicators, the highest weight was assigned to ″Structure″ (0.443 2). The top three secondary indicators were ″Data analysis report″ (0.098 3), ″Study protocol execution and data archiving″ (0.096 0), and ″Research team″ (0.094 1). At the tertiary level, the highest-ranked indicators were ″Data cleaning, verification, and database locking″ (0.049 2), ″Archiving and preservation of research data″ (0.048 8), and ″Execution of statistical analysis as planned″ (0.048 4).Conclusions:The ophthalmology IIT process quality evaluation index system developed in this study is scientifically grounded and will provides a valuable reference for standardizing quality management and further empirical research in ophthalmology IITs.

Objective:To investigate the clinical effect of indocyanine green angiography (ICGA)-assisted design and harvest of expanded flaps for scar reconstruction.Methods:This study was a retrospective observational study. From April 2019 to August 2023, 19 patients with scars (8 males, 11 females; aged 3-38 years) treated at the Plastic Surgery Hospital of Peking Union Medical College and Chinese Academy of Medical Sciences met the inclusion criteria. The scars were distributed on the head, face, trunk, and extremities. In stage Ⅰ surgery, skin soft tissue expanders were implanted in suitable areas around the scars for skin soft tissue expansion. In stage Ⅱ surgery, the scar tissue was excised, resulting in wound areas ranging from 100 to 210 cm 2, and expanded flaps were designed. ICGA was used to identify target perforators and their accompanying veins, and the flap design was adjusted to ensure the inclusion of complete arterial and venous axes. The expanded flap with an area of 120 to 240 cm2 was harvested using unilateral back-cut technique and transferred to the recipient site, and the donor site wound was sutured directly. The durations of the arterial and venous phases of ICGA during flap design were recorded. The length-to-width ratios of the back-cut flaps were calculated for different regions. After stage Ⅱ surgery, the blood perfusion and survival of the flap, the wound healing at the donor site, and the occurrence of complications were observed. During follow-up, the appearance, color, and texture of the patient's flap were observed. Results:The arterial phase of ICGA lasted 10-27 (18±5) s, and the venous phase lasted 78-116 (100±10) s. The length-to-width ratios of the back-cut flaps were 1.22±0.32, 1.63±0.12, and 1.15±0.21 for the head and neck, trunk, and limb regions, respectively. After stage Ⅱ surgery, one patient had a large area of insufficient blood perfusion in the flap. By comparing ICGA images before and after flap transfer, the sutures at the oral commissure were loosened, the blood flow of the flap was restored. The blood perfusion of the flaps in other patients was good. All flaps survived completely, with well-healed donor site wounds and no complications. During 0.5-14.0 months of follow-up, all flaps of patients demonstrated excellent appearance, with color and texture matching the surrounding skin.Conclusions:As a means of superficial blood flow visualization, ICGA can not only clearly show the microvascular distribution of the expanded flap before operation, assist in optimizing the design of the flap, but also evaluate the blood perfusion of the flap after operation, reduce the occurrence of complications, and provide a full-process navigation for the harvesting of expanded flaps, thereby improving the safety of flap transfer for scar reconstruction.

Objective:To explore the short-term clinical effects of deep cervical lymph node-venous anastomosis in the treatment of Alzheimer’s disease (AD).Methods:A prospective exploratory study was conducted on the treatment of AD patients using the cervical deep lymph node-venous anastomosis technique in Scar and Wound Treatment Department, Plastic Surgery Hospital, Chinese Academy of Medical Sciences, from September to October 2024. The patients underwent high-frequency ultrasound to locate deep cervical lymph nodes and the external jugular vein. Under general anesthesia, bilateral deep cervical lymph node-venous anastomoses were performed. Indocyanine green (ICG) lymphography was conducted via subcutaneous injection behind the ear to visualize lymph nodes in levels Ⅱ and Ⅲ. After making a skin incision along the posterior margin of the sternocleidomastoid muscle, the external jugular vein, internal jugular veins, and associated lymph nodes were exposed. Adjacent veins were selected for anastomosis of lymph node. Using microsurgical techniques, end-to-side or end-to-end anastomosis was completed for lymph nodes in levels Ⅱ and Ⅲ. Preoperative assessments included the mini-mental state examination (MMSE, a higher score indicates better cognitive function), Alzheimer’s disease assessment scale-cognitive subscale (ADAS-Cog, a higher score indicates greater impairment of cognitive function), Alzheimer’s disease cooperative study scale for activities of daily living (ADCS-ADL, a higher score indicates better ability to perform daily activity), and neuropsychiatric inventory (NPI, a higher score indicates more severe behavioral and emotional symptom). Postoperative follow-up included the same scales to observe changes in cognitive function, activities of daily living, and emotional communication.Results:Four patients (1 male, 3 females, aged 58-79 years) with AD were included. All were diagnosed based on cerebrospinal fluid biomarkers. All patients successfully underwent bilateral deep cervical lymph node-venous anastomoses. On average, 4.3 (2-7 per person) anastomoses were performed per patient. Surgical procedures lasted an average of 6.5 h (5.5-8.5 h) with minimal blood loss (less than 50 ml). Patients resumed normal activity within 6 hours postoperatively and were discharged after an average of 4.1 d (3.5-5.0 d). Postoperative complications included one case each of aspiration pneumonia, lower limb venous thrombosis, and transient delirium, all of whom resolved without long-term effects. Clinical symptoms, including memory decline, mood swings, and anxiety, showed varying degrees of improvement. Patients reported enhanced quality of life, emotional stability, and social engagement, confirming the procedure’s safety and potential cognitive benefits. At one month postoperatively, the MMSE scores of the four patients increased by an average of 0.8 points compared to preoperative levels. Additionally, the two patients who completed the ADAS-Cog assessments showed a decrease in their scores (reduced by 1.0 points and 11.3 points, respectively, compared to preoperative scores), indicating a certain degree of improvement in cognitive function during this period. The ADCS-ADL and NPI scores of four patients varied significantly, without showing any clear pattern.Conclusion:Lymphovenous anastomosis of the deep cervical lymph node-venous anastomosis may provide a new surgical intervention approach for AD, but further large-scale studies and long-term follow-up are needed to validate its safety and effectiveness.

Purpose To explore the clinical manifestations,imaging features,and histopathological characteristics of intravascular large B-cell lymphoma(IVL-BCL)involving the central nervous system(CNS).Methods Clinical and imaging data from 5 cases of IVL-BCL were collected.Immunohistochemical staining and FISH were performed to analyze their clinicopathological characteristics,with a comprehensive review of relevant literatures.Results All 5 pa-tients were elderly,with a male-to-female ratio of 4∶1,and an age of onset ranging from 53 to 67 years.The disease course varied from 4 months to 2 years.All patients had varying degrees of neurological damage symptoms.In this study,4 patients experienced varying degrees of weakness in the lower limbs.MRI findings were nonspecific,but all 5 patients showed evidence of cerebrovascular lesions.Histologically,the lesions were characterized by aggregates of lymphoid tumor cells within the lumens of small cerebral vessels,which could obstruct the lumens and cause ischemic and hypoxic changes.Tumor cells did not involve the extravascular brain parenchyma.Immunohistochemically,tumor cells widely expressed mature B-cell markers(CD19,CD20,CD79a,PAX5)with a high Ki67 proliferation index.All 5 patients received systemic chemotherapy after diagnosis,1 patient died,2 patients achieved clinical and physical symptom relief and were still under follow-up.2 patients were undergoing systemic examination before chemotherapy.Conclusion Intravascular large B-cell lymphoma involving the central nervous system is rare,and both clinical mani-festations and imaging examinations lack specific indicators.Preoperative diagnosis is very difficult and can only rely on diagnostic brain biopsy or pathological diagnosis after craniotomy.

Liver diseases, particularly cirrhosis and cancer, significantly threat human health for a long time, and their diagnosis and treatment are important topics in medical research. Tradi-tional diagnostic and therapeutic approaches have focused on biochemical properties of liver diseases, yet often neglecting the mechanical microenvironment of liver at molecular, cellular, and tissue levels. This oversight makes it difficult to meet clinical needs. Recent advancements in biomechanics and mechanobiology have underscored the importance of mechanical properties of liver in understanding disease mechanisms, presenting profound implications for both basic research and clinical practice. However, there is still a lack of in-depth exploration of the mechanical properties of liver in both basic research and clinical treatment, making it unclear of the specific mechanisms and application scenarios. The authors propose and introduce the emerging field of liver mechanomedicine, examine the biomechanical properties of liver and their alterations during disease progression, elucidate mechanobiological mechanisms of cellular mechanical responses and signal transduction, explore the application of mechanical characteristics in the diagnosis and treatment of liver diseases, aiming to provide a new perspective for basic research and clinical practice.

Purpose To explore the clinical manifestations,imaging features,and histopathological characteristics of intravascular large B-cell lymphoma(IVL-BCL)involving the central nervous system(CNS).Methods Clinical and imaging data from 5 cases of IVL-BCL were collected.Immunohistochemical staining and FISH were performed to analyze their clinicopathological characteristics,with a comprehensive review of relevant literatures.Results All 5 pa-tients were elderly,with a male-to-female ratio of 4∶1,and an age of onset ranging from 53 to 67 years.The disease course varied from 4 months to 2 years.All patients had varying degrees of neurological damage symptoms.In this study,4 patients experienced varying degrees of weakness in the lower limbs.MRI findings were nonspecific,but all 5 patients showed evidence of cerebrovascular lesions.Histologically,the lesions were characterized by aggregates of lymphoid tumor cells within the lumens of small cerebral vessels,which could obstruct the lumens and cause ischemic and hypoxic changes.Tumor cells did not involve the extravascular brain parenchyma.Immunohistochemically,tumor cells widely expressed mature B-cell markers(CD19,CD20,CD79a,PAX5)with a high Ki67 proliferation index.All 5 patients received systemic chemotherapy after diagnosis,1 patient died,2 patients achieved clinical and physical symptom relief and were still under follow-up.2 patients were undergoing systemic examination before chemotherapy.Conclusion Intravascular large B-cell lymphoma involving the central nervous system is rare,and both clinical mani-festations and imaging examinations lack specific indicators.Preoperative diagnosis is very difficult and can only rely on diagnostic brain biopsy or pathological diagnosis after craniotomy.

Liver diseases, particularly cirrhosis and cancer, significantly threat human health for a long time, and their diagnosis and treatment are important topics in medical research. Tradi-tional diagnostic and therapeutic approaches have focused on biochemical properties of liver diseases, yet often neglecting the mechanical microenvironment of liver at molecular, cellular, and tissue levels. This oversight makes it difficult to meet clinical needs. Recent advancements in biomechanics and mechanobiology have underscored the importance of mechanical properties of liver in understanding disease mechanisms, presenting profound implications for both basic research and clinical practice. However, there is still a lack of in-depth exploration of the mechanical properties of liver in both basic research and clinical treatment, making it unclear of the specific mechanisms and application scenarios. The authors propose and introduce the emerging field of liver mechanomedicine, examine the biomechanical properties of liver and their alterations during disease progression, elucidate mechanobiological mechanisms of cellular mechanical responses and signal transduction, explore the application of mechanical characteristics in the diagnosis and treatment of liver diseases, aiming to provide a new perspective for basic research and clinical practice.

Objective:To develop an evaluation index system for the quality management process of investigator-initiated trials(IITs) in ophthalmology, providing a scientific tool and reference for improving clinical research quality and standardized management.Methods:Key quality management elements of ophthalmology IITs were identified through a literature review and experts interviews. A three-round Delphi consultation was conducted with experts from 16 provinces and municipalities in China who specialize in ophthalmic clinical research management. The importance of each index was scored, and weighting calculations were performed. Based on ranking and feasibility, a validated quality index system for ophthalmology IITs was established.Results:A three-tier index system was developed, comprising three first-level indicators (structure, process, and outcome), 15 secondary indicators, and 44 tertiary indicators. The expert authority coefficient was 0.87, and the response rates for the three Delphi rounds were 100%, 92.58%, and 100%, respectively. Among the first-level indicators, the highest weight was assigned to ″Structure″ (0.443 2). The top three secondary indicators were ″Data analysis report″ (0.098 3), ″Study protocol execution and data archiving″ (0.096 0), and ″Research team″ (0.094 1). At the tertiary level, the highest-ranked indicators were ″Data cleaning, verification, and database locking″ (0.049 2), ″Archiving and preservation of research data″ (0.048 8), and ″Execution of statistical analysis as planned″ (0.048 4).Conclusions:The ophthalmology IIT process quality evaluation index system developed in this study is scientifically grounded and will provides a valuable reference for standardizing quality management and further empirical research in ophthalmology IITs.

Objective:To investigate the clinical effect of indocyanine green angiography (ICGA)-assisted design and harvest of expanded flaps for scar reconstruction.Methods:This study was a retrospective observational study. From April 2019 to August 2023, 19 patients with scars (8 males, 11 females; aged 3-38 years) treated at the Plastic Surgery Hospital of Peking Union Medical College and Chinese Academy of Medical Sciences met the inclusion criteria. The scars were distributed on the head, face, trunk, and extremities. In stage Ⅰ surgery, skin soft tissue expanders were implanted in suitable areas around the scars for skin soft tissue expansion. In stage Ⅱ surgery, the scar tissue was excised, resulting in wound areas ranging from 100 to 210 cm 2, and expanded flaps were designed. ICGA was used to identify target perforators and their accompanying veins, and the flap design was adjusted to ensure the inclusion of complete arterial and venous axes. The expanded flap with an area of 120 to 240 cm2 was harvested using unilateral back-cut technique and transferred to the recipient site, and the donor site wound was sutured directly. The durations of the arterial and venous phases of ICGA during flap design were recorded. The length-to-width ratios of the back-cut flaps were calculated for different regions. After stage Ⅱ surgery, the blood perfusion and survival of the flap, the wound healing at the donor site, and the occurrence of complications were observed. During follow-up, the appearance, color, and texture of the patient's flap were observed. Results:The arterial phase of ICGA lasted 10-27 (18±5) s, and the venous phase lasted 78-116 (100±10) s. The length-to-width ratios of the back-cut flaps were 1.22±0.32, 1.63±0.12, and 1.15±0.21 for the head and neck, trunk, and limb regions, respectively. After stage Ⅱ surgery, one patient had a large area of insufficient blood perfusion in the flap. By comparing ICGA images before and after flap transfer, the sutures at the oral commissure were loosened, the blood flow of the flap was restored. The blood perfusion of the flaps in other patients was good. All flaps survived completely, with well-healed donor site wounds and no complications. During 0.5-14.0 months of follow-up, all flaps of patients demonstrated excellent appearance, with color and texture matching the surrounding skin.Conclusions:As a means of superficial blood flow visualization, ICGA can not only clearly show the microvascular distribution of the expanded flap before operation, assist in optimizing the design of the flap, but also evaluate the blood perfusion of the flap after operation, reduce the occurrence of complications, and provide a full-process navigation for the harvesting of expanded flaps, thereby improving the safety of flap transfer for scar reconstruction.

Objective:To explore the short-term clinical effects of deep cervical lymph node-venous anastomosis in the treatment of Alzheimer’s disease (AD).Methods:A prospective exploratory study was conducted on the treatment of AD patients using the cervical deep lymph node-venous anastomosis technique in Scar and Wound Treatment Department, Plastic Surgery Hospital, Chinese Academy of Medical Sciences, from September to October 2024. The patients underwent high-frequency ultrasound to locate deep cervical lymph nodes and the external jugular vein. Under general anesthesia, bilateral deep cervical lymph node-venous anastomoses were performed. Indocyanine green (ICG) lymphography was conducted via subcutaneous injection behind the ear to visualize lymph nodes in levels Ⅱ and Ⅲ. After making a skin incision along the posterior margin of the sternocleidomastoid muscle, the external jugular vein, internal jugular veins, and associated lymph nodes were exposed. Adjacent veins were selected for anastomosis of lymph node. Using microsurgical techniques, end-to-side or end-to-end anastomosis was completed for lymph nodes in levels Ⅱ and Ⅲ. Preoperative assessments included the mini-mental state examination (MMSE, a higher score indicates better cognitive function), Alzheimer’s disease assessment scale-cognitive subscale (ADAS-Cog, a higher score indicates greater impairment of cognitive function), Alzheimer’s disease cooperative study scale for activities of daily living (ADCS-ADL, a higher score indicates better ability to perform daily activity), and neuropsychiatric inventory (NPI, a higher score indicates more severe behavioral and emotional symptom). Postoperative follow-up included the same scales to observe changes in cognitive function, activities of daily living, and emotional communication.Results:Four patients (1 male, 3 females, aged 58-79 years) with AD were included. All were diagnosed based on cerebrospinal fluid biomarkers. All patients successfully underwent bilateral deep cervical lymph node-venous anastomoses. On average, 4.3 (2-7 per person) anastomoses were performed per patient. Surgical procedures lasted an average of 6.5 h (5.5-8.5 h) with minimal blood loss (less than 50 ml). Patients resumed normal activity within 6 hours postoperatively and were discharged after an average of 4.1 d (3.5-5.0 d). Postoperative complications included one case each of aspiration pneumonia, lower limb venous thrombosis, and transient delirium, all of whom resolved without long-term effects. Clinical symptoms, including memory decline, mood swings, and anxiety, showed varying degrees of improvement. Patients reported enhanced quality of life, emotional stability, and social engagement, confirming the procedure’s safety and potential cognitive benefits. At one month postoperatively, the MMSE scores of the four patients increased by an average of 0.8 points compared to preoperative levels. Additionally, the two patients who completed the ADAS-Cog assessments showed a decrease in their scores (reduced by 1.0 points and 11.3 points, respectively, compared to preoperative scores), indicating a certain degree of improvement in cognitive function during this period. The ADCS-ADL and NPI scores of four patients varied significantly, without showing any clear pattern.Conclusion:Lymphovenous anastomosis of the deep cervical lymph node-venous anastomosis may provide a new surgical intervention approach for AD, but further large-scale studies and long-term follow-up are needed to validate its safety and effectiveness.