RESUMO
BACKGROUND: Myopia is a public health problem worldwide and its incidence increases with age. The use of acupuncture to treat myopia is a common practice in China, however, the use of acupuncture to treat myopia is disputed in other parts of the world. This study aims to determine the safety of acupuncture to treat myopia and its efficacy over six months. METHODS/DESIGN: A randomized, parallel, single-center, assessor- and statistician-blinded, controlled clinical trial will be performed. A total of 100 teenagers, between seven and 12 years of age, with mild-to-moderate myopia and spherical lenses <-6.00 D and cylindrical lenses <-1.50 D will be selected from the Xinjiang Uygur Autonomous Region Institute of Traditional Chinese Medicine, a grade III level A teaching hospital in Urumqi, Xinjiang, China (Xinjiang Medical University Affiliated Hospital of Traditional Medicine). The subjects will be randomly assigned to two different groups (control and acupuncture groups), each group containing 50 subjects. The subjects in both groups wear single-vision corrective lenses. In the acupuncture group, acupuncture will be performed daily for nine consecutive days on five points (bilateral Cuanzhu, Tongziliao, Sibai, Muchuang, and Hegu), followed by no treatment for one day. Six cycles of treatment will be undertaken continuously for a total of 60 days. Following 60 days of treatment, a follow-up period of six months will be included. The primary outcome will be diopter determination. The secondary outcomes will include distance visual acuity, axial length, lens thickness, ciliary body thickness, and subjective symptoms of the eyes and entire body. The main time points for the evaluation of clinical efficacy will be the first, third, and sixth months after treatment. DISCUSSION: This study will provide clinical observations of various indices following the use of acupuncture to treat adolescents with mild-to-moderate myopia, as well as information on the safety of acupuncture. TRIAL REGISTRATION: Chinese Clinical Trial Registry (identifier: ChiCTR-TRC-13003448; registration date: 7 August 2013).
Assuntos
Terapia por Acupuntura , Miopia/terapia , Projetos de Pesquisa , Pontos de Acupuntura , Fatores Etários , Criança , Pré-Escolar , China , Protocolos Clínicos , Óculos , Feminino , Hospitais de Ensino , Humanos , Masculino , Miopia/diagnóstico , Miopia/fisiopatologia , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento , Acuidade VisualRESUMO
AIM: To compare the clinical effects of the modified and conventional secondary hydroxyapatite orbital implantations. METHODS: A total of 40 patients who had received eye enucleation were equally randomized into the modified and conventional groups. Twenty patients were treated by conventional method. The four rectus muscles were separated, and then an orbital implant wrapped with xenogenous sclera was implanted. Twenty patients were treated by modified method. An implant unwrapped with xenogenous sclera was directly implanted into the muscle pyramid. The operating time, costs, clinical effects, and complications of the two groups were compared. RESULTS: The average operating time of the modified group was 20.5±5.6min, whereas that of the conventional group was 56.8±14.6min (P<0.01). The average cost of the modified group was 7 800±340RMB (1 274±55.6USD), whereas that of the conventional group was 9 800±660RMB (1 601±107.8USD) (P<0.01). The two groups did not show significant difference in orbital implant mobility or postoperative complications. CONCLUSION: The modified secondary hydroxyapatite orbital implantation has advantages in operating time, surgery cost, and complication reducing. It is worthy for wide clinical application and further study.