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.

Angle class Ⅱ malocclusion is often characterized by mandibular retraction and lip incompetence,which affects the patient's lateral appearance and may even lead to upper airway stenosis.It can be classified into dental and skeletal types.For skeletal class Ⅱ malocclusion patients with mandibular retraction during the peak growth period,mandibular anterior guidance with a functional orthodontic appliance is generally considered as the optimal clinical treatment approach.At present,there remains a paucity of clinical reports on the clinical application of bracket-free clear aligners in mandibular anterior guidance,both domestically and internationally.This article presented a case of an adolescent patient with skeletal class Ⅱ malocclusion accompanied with deep overbite treated with bracket-free clear aligner for mandibular anterior guidance in combination with intermaxillary class Ⅱ traction.During the treatment,vertical correction involved anterior intrusion of the anterior teeth to improve the deep overbite,while horizontal correction included maxillary and mandibular expansion to coordinate the width of the dental arches,and asymmetric anterior guidance was used to correct the midline deviation.After 35 months of treatment,the patient's convex facial profile and mandibular retrusion were significantly improved.The subspinale-nasion-supramentale angle(ANB)was decreased from 6.8° to 3.9°,the overbite and overjet were normalized,and the bilateral canine and molar reached a neutral relationship.The mentolabial sulcus depth(Si-LiPg′)and the soft tissue thickness of pogonion to pogonion(Pm-Pm′)were decreased,resulting in a shallower mentolabial sulcus and a more harmonized lateral facial soft tissue profile.The mandibular incisor to mandibular plane angle(IMPA)was decreased from 116.6° to 110.7°,indicating retraction of the lower incisors during mandibular anterior guidance.In conclusion,the orthodontic strategy of mandibular advancement with clear aligners in skeletal class Ⅱ malocclusion patients can avoid excessive overcompensation of the upper and lower anterior teeth and shorten the orthodontic treatment cycle.

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 evaluate the efficacy and safety of epalrestat, an aldose reductase inhibitor, and epalrestat plus methylcobalamine on diabetic peripheral neuropathy, as compared with methylcobalamine. Methods A total of 444 subjects with diabetic neuropathy were enrolled in the study, and divided into methylcobalamine group ( n= 145 ) , epalrestat group ( n = 143 ) , and methylcobalamine combined with epalrestat group ( n = 156 ) . Therapeutic efficacay was assessed in terms of clinical symptoms and physical examinations by using Michigan Neuropathy Screening Instrument ( MNSI ) , and electrophysiological assessments. Results After 4 to 12-weeks′treatment, symptoms and signs of neuropathy ( using MNSI ) are significantly improved in the three groups ( P<0. 01). The mean changes of MNSI ( questionnaire) score from baseline were higher in epalrestat group and methylcobalamine combined with epalrestat group as compared with that of methylcobalamine group(P<0. 05), but no difference was detected in the change of MNSI ( physical examination ) score from baseline among three groups. After treatment for 12 weeks, motor nerve conduction velocity ( MNCV ) was significantly improved in epalrestat group and methylcobalamine combined with epalrestat group(P<0. 05), but no difference was detected in MNCV at 12 week among three groups(P>0. 05). Conclusion Epalrestat is effective and safe in the treatment of diabetic neuropathy. Furthermore, epalrestat is more efficacious in ameliorating symptoms and MNCV of neuropathy than methylcobalamine. However, while no improved efficacy is shown with the combined treatment.