Triple Procedure for Dense Cataractus Neovascular Glaucoma Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- BCDVA
研究概览
简要总结
Background: One of the most difficult refractory glaucomas in treatment is the neovascular type and its association with dense cataract add to this difficulty. This study aimed to provide results of triple surgical treatment of such conditions.
Methods: A total of 12 eyes of 12 patients with dense cataractus NVG patients were included in this study. The patients mean age was 57.25 ± 5.9 years. The mean pre-operative intraocular pressure (IOP) was 47.25 ± 4.04 mmHg with maximum antiglaucoma therapy. The mean best corrected distant visual acuities (BCDVA) in log MAR was 2.13 ± 0.38. All the patients received intra-vitreal injection of 1.25 mg (0.05 ml) bevacizumab followed by phacoemulsification, pars plana vitrectomy (PPV) including pan-retinal photocoagulation (PRP), and assisted trabeculectomy with Mitomycin c (MMC). Mean IOP and BCDVA changes were the main outcome results of this study.
详细描述
Introduction Ocular ischemia due to diabetic retinopathy (DR) and central retinal vein occlusion (CRVO) are the most common causes that contribute to the development of neovascular glaucoma (NVG). Ischemic retina derived factors like vascular endothelial growth factor (VEGF) that can affect the anterior segment and initiates neovascularization in the iris (NVI), neovascularization in the angle (NVA). Aqueous outflow is obstructed when neovascular fibrous tissues block the trabecular meshwork and leads to synechial angle closure, thus NVG develops. Intraocular pressure (IOP) rise due to NVG lowers the ocular perfusion leading to further retinal ischemia, and this in turn induces more neovascularization. The management of NVG is very difficult thus; the conventional treatments such as antiglaucoma drugs, trabeculectomy, cyclophotocoagulation and cyclocryotherapy have poor success rates. It is very important to reduce the ischemic drive promptly for the treatment of NVG. Pan-retinal photocoagulation (PRP) is a mandatory and effective in resolving the ischemic condition and decreasing the vasoproliferative factors production.[ This management is particularly difficult in eyes with dense cataract. However, it is possible to overcome this difficulty by doing phacoemulsification and pars plana vitrectomy (PPV) + PRP. Moreover, phacoemulsification combined with PPV enables us to apply PRP from the posterior pole to the ora serrata peripherally. It has been known that Mitomycin C (MMC) increase the success rate of trabeculectomy in patients with NVG. Therefore, in the current study, we performed Intravitreal bevacizumab (IVB) injection, phacoemulsification, PPV + PRP and trabeculectomy augmented with subconjunctival injection of MMC.
The aim of this study is to evaluate safety and efficacy of this combined surgical procedure to alleviate retinal ischemia, reduce IOP, and improve visual acuity in dense cataractus NVG patients.
Subjects and Methods
Twelve eyes of 12 patients with NVG associated with dense cataract enough to obscure fundus visualization (7 males, 5 females) were included in the study in the period from July 2016 to August 2019 at Ophthalmology Department, Faculty of Medicine, Minia University. The patient's age ranged from 47 to 66 years with a mean age of 57.25 ± 5.9 years. The underlying cause for NVG was diabetes mellitus (DM) in 8 eyes (75%) and CRVO in 4 eyes (33.33%). Vitreous hemorrhage was present in half (50%) of the patients. The study was approved by the Local Ethical Review Committee and adhered to the tents of Declaration of Helsinki as well as all patients singed a written consent after discussion of the potential benefits and risks of this triple surgical procedures.
Preoperative examinations: Routine ophthalmological examinations were done after history taking including, age, sex, laterality, etiology of NVG and number of used anti-glaucoma drugs. The ocular examination includes estimation of visual acuity, IOP measurement with Goldman applanation tonometer, slit lamp examination of anterior segment, gonioscopy examination of angle of anterior chamber, biometry and ultrasonography. The demographic data were registered as in (Table 1).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 47 Years 至 66 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study included patients with uncontrolled angle closure dense cataractus NVG with maximum tolerated anti-glaucoma medications.
排除标准
- •Excluded from this study eyes that had previous anti-glaucoma procedures, silicone oil filled eyes, previous buckle surgery or Conjunctival scaring from any cause, eyes with clear crystalline lens or faint cataract, eyes with corneal opacity, and eyes with visual acuity less than hand motion with good perception of light.
结局指标
主要结局
BCDVA
时间窗: 2 years
Best corrected distant visual acuity
IOP
时间窗: 2 years
Intra-ocular pressure
次要结局
- Post-operative complications(2 years)
研究者
Shaaban Elwan
Assistant professor of ophthalmology
Minia University
