Comparison of Efficacy and Safety of Mitomycin and Aflibercept Used to Support Primary Trabeculectomy - a Prospective, Randomized Trial in Patients With Open-angle Glaucoma Undergoing Surgery.
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Effectiveness of aflibercept and mitomycin on the morphology of the bleb;
研究概览
简要总结
Comparison of efficacy and safety of Mitomycin and Aflibercept used to support primary trabeculectomy - a prospective, randomized trial in patients with open-angle glaucoma undergoing surgery.
详细描述
Glaucoma is a neurodegenerative disease characterized by progressive dying of retinal ganglion cells, axonal loss and damage to the optic nerve. This leads to a gradual loss of the visual field, and in the final stage to blindness. High intraocular pressure is considered to be the main risk factor for glaucomatous neuropathy. In the treatment we use pharmacological therapies and surgical treatment. The trabeculectomy has been the golden standard for the treatment of glaucoma for many years. This procedure consisting in the creation of a filtering bleb, which allows drainage of aqueous humor from within the eye to underneath the conjunctiva where it is absorbed. in addition to the surgery, anti-proliferative substances play a significant role in suppressing the physiological healing process. Bleb insufficiency observed in the postoperative period results to a large extent from progressive scarring of the follicle, which is responsible for excessive fibroblast proliferation and subconjunctival fibrosis.
Mitomycin is an antineoplastic antibiotic produced by Streptomyces caespitosus. It is one of the bi- or tri-functional alkylating agents causing cross-linking of DNA and inhibition of DNA synthesis. Its properties cause that mitomycin is now a popular medicine used to support trabeculectomy, with proven effectiveness of inhibiting the unwanted healing process of the fistula, and thus extend its period of its proper functioning.
Aflibercept is an inhibitor of vascular endothelial growth factor (VEGF). Its properties cause inhibition of the pathological process of formation of new vessels and their excessive permeability, as well as reduction of leukocyte infiltration and inflammation.
The aim of the research:
Comparison of the effectiveness of primary trabeculectomy in patients with open angle glaucoma supported with Eylea (Aflibercept) compared to the group of patients treated with mitomycin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary open-angle glaucoma or capsular glaucoma.
- •Patient's age: over 40 years, no sex preference;
- •Local treatment ineffective due to:
- •Intraocular pressure above 21mmHg at maximum pharmacological therapy (using β-blocker + carbonic anhydrase inhibitor + prostaglandins) or
- •Intolerance to topical treatment or
- •Progression in visual field examination
- •Lack of previous ophthalmological surgical interventions.
- •Lack of previously performed laser gonioplasty.
- •No laser trabeculoplasty or laser trabeculoplasty performed for more than a year.
排除标准
- •Patient with primary closed-angle glaucoma or secondary glaucoma (except for glaucoma in the course of pseudoexfoliation syndrome).
- •One-eye patient.
- •Patient with aphakia.
- •Patient after previous ophthalmic procedures (cataract removal by phacoemulsification with an implant of an intraocular lens, vitrectomy by pars plana, keratoplasty).
- •A patient diagnosed or suspected of having uveitis or intraocular inflammation.
- •Any corneal abnormalities or other conditions that prevent reliable testing with an applanation device in the treated eye, including earlier refractive surgery of the eye.
研究组 & 干预措施
Aflibercept
Aflibercept applied intraoperatively as a subconjunctival injection at a dose of 0.05 ml (40 mg / ml) and one week after the operation at the same dose, also subconjunctival.
干预措施: Aflibercept (Drug)
Mitomycin
Mitomycin applied during a surgery at a concentration of 0.3mg / ml for 3 min. on a soaked sponge.
干预措施: Mitomycin (Drug)
结局指标
主要结局
Effectiveness of aflibercept and mitomycin on the morphology of the bleb;
时间窗: 1 year
Rating the bleb in The Indiana Bleb Appearance Grading Scale, describing bleb height, extent, vascularity, and leakage with the Seidel test.
Effectiveness of aflibercept and mitomycin on the function of the bleb;
时间窗: 1 year
Measurement of intraocular pressure (Goldmann applanation tonometer) and taking a photo of a bleb.
次要结局
- The influence of aflibercept and mitomycin on corneal endothelial cell density after surgery(1 year)
- Impact of used substances on visual field parameters(1 year)
- Impact of tested substances on visual acuity after surgery(1 year)
- Frequencies and type of possible complications.(1 year)
研究者
Justyna Kaproń-Świś
Medical Doctor
Medical University of Lublin