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Trials ; 25(1): 287, 2024 Apr 29.
Artigo em Inglês | MEDLINE | ID: mdl-38679725

RESUMO

BACKGROUND: Neovascular glaucoma (NVG) is an irreversible blinding eye disease worldwide and is classified as one of the refractory glaucoma conditions, severely impacting visual function and vision. Unfortunately, effective surgical interventions to improve the prognosis of NVG patients are currently lacking. The study aims to evaluate the efficacy and safety of anterior chamber proliferative membrane interception (AC-PMI)-enhanced trabeculectomy compared to the traditional trabeculectomy. METHODS: AC-PMI enhanced trabeculectomy versus trabeculectomy for the treatment of NVG is a single-center, prospective, double-arms, and randomized controlled trial of superior efficacy, which will involve 100 NVG inpatients. Patients will be randomly assigned into two groups using the random number table method. One group will undergo trabeculectomy using anti-vascular endothelial growth factor (Anti-VEGF) preoperatively and mitomycin C intraoperatively, while the other group will undergo AC-PMI enhanced trabeculectomy with the same medications (Anti-VEGF and mitomycin C). The patients will be followed up at the baseline and 1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, and 24 months postoperatively. Meanwhile, we will collect the demographics, characteristics, and examination results and monitor any occurrences of adverse events at each follow-up time. DISCUSSION: This is an efficacy study of a novel surgical approach for treating neovascular glaucoma. Building upon conventional filtering surgeries, this approach introduces an additional step involving the interception of the proliferative membrane to effectively halt the growth of fibrovascular tissue. This study aims to explore a promising new surgical approach for managing NVG and contribute to the advancement of glaucoma treatment strategies. TRIAL REGISTRATION: ChiCTR ChiCTR2200055138. Registered on 01 January 2022. https://www.chictr.org.cn/showproj.html?proj=145255.


Assuntos
Glaucoma Neovascular , Ensaios Clínicos Controlados Aleatórios como Assunto , Trabeculectomia , Fator A de Crescimento do Endotélio Vascular , Humanos , Trabeculectomia/métodos , Trabeculectomia/efeitos adversos , Glaucoma Neovascular/cirurgia , Glaucoma Neovascular/fisiopatologia , Estudos Prospectivos , Resultado do Tratamento , Pessoa de Meia-Idade , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores , Idoso , Feminino , Masculino , Adulto , Câmara Anterior/cirurgia , Pressão Intraocular , Mitomicina/uso terapêutico , Mitomicina/administração & dosagem , Inibidores da Angiogênese/uso terapêutico , Inibidores da Angiogênese/administração & dosagem , Adulto Jovem
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