Effectiveness of Lens Extraction Combined With Goniosynechialysis Versus Trabeculectomy in Treating Advanced Angle-closure Glaucoma: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 316
- 试验地点
- 1
- 主要终点
- Best corrected visual acuity at three years
研究概览
简要总结
To compare the effectiveness of lens extraction combined with goniosynechialysis and trabeculectomy in treating advanced angle-closure glaucoma.
详细描述
Advanced angle closure glaucoma (AACG) can result in severe visual function defect or even blindness with or without acute attacks. Different from open angle glaucoma (OAG), the main principle of treatment for AACG is not only to lower intraocular pressure (IOP) but also to protect the anterior chamber angle from closing. Previously, the most common and classical treatment for AACG was trabeculectomy. However, both doctors and patients are not satisfied with this surgery because of its limited success rate due to fibrosis of the filtration pathway. Besides, trabeculectomy has various complications, such as shallow anterior chamber, choroidal effusion, suprachoroidal hemorrhage, malignant glaucoma, and bleb leakage associated endophthalmitis. In addition, patients who underwent trabeculectomy will have decreased visual acuity in a couple of years due to accelerated development of cataract. Since a thickened and anterior-positioned lens could play a crucial role in the pathogenesis of AACG, cataract surgery has also been used. Accumulative evidence shows lens extraction alone is an efficient way in treating the early stage of ACG but has limited success rate in AACG. Lens extraction combined with goniosynechialysis (LEG) has been proved to be better than lens extraction alone in re-opening the anterior chamber angle for ACG patients with extensive peripheral anterior synechia and possibly have better effect than trabeculectomy as well from our preliminary data, which has not been proved yet. Thus, this investigation is designed to compare the effect of LEG and trabeculectomy in AACG patients prospectively in 3 years of follow-up. The investigators hypothesize that LEG could have better IOP control and better visual function than trabeculectomy in long term for AACG patients.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40 years old to 80 years old
- •more than 180-degree synechial closure of anterior chamber angle on gonioscopy
- •IOP higher than 21mmHg under the use of more than two anti-glaucoma eye drops
- •mean deviation of visual field worse than -12dB on Humphrey 24-2
- •phakic eyes
排除标准
- •Snellen visual acuity worse than 0.02
- •history of ocular trauma
- •previous ocular surgeries
- •significant conjunctival scar
- •visible neovascular on iris or anterior chamber angle
- •other severe eye diseases that would affect visual function significantly, such as age-related macular degeneration and pathogenic myopia.
结局指标
主要结局
Best corrected visual acuity at three years
时间窗: three years
Best corrected visual acuity of participants after surgery at three years
Intraocular pressure (IOP) change at one month
时间窗: one month
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at one month.
Best corrected visual acuity at six months
时间窗: six months
Best corrected visual acuity of participants after surgery at six months
Best corrected visual acuity at one month
时间窗: one month
Best corrected visual acuity of participants after surgery at one month
IOP change at three months
时间窗: three months
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at three months.
IOP change at six months
时间窗: six months
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at six months.
IOP change at two years
时间窗: two years
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at two years.
Best corrected visual acuity at three months
时间窗: three months
Best corrected visual acuity of participants after surgery at three months
IOP change at one year
时间窗: one year
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at one year.
IOP change at three years
时间窗: three years
Change from baseline IOP after phacoemulsification combined with goniosynechialysis or trabeculectomy at three years.
Best corrected visual acuity at one year
时间窗: one year
Best corrected visual acuity of participants after surgery at one year
Best corrected visual acuity at two years
时间窗: two years
Best corrected visual acuity of participants after surgery at two years
次要结局
- Number of eye drops(one month, three months, six months, one year, two years, three years)
- Mean deviation(one month, three months, six months, one year, two years, three years)
- The thickness of ganglion cell complex (GCC)(one month, three months, six months, one year, two years, three years)
- Adverse event(one month, three months, six months, one year, two years, three years)
- The thickness of retinal nerve fiber layer (RNFL)(one month, three months, six months, one year, two years, three years)
研究者
Yuhong Chen
Professor
Eye & ENT Hospital of Fudan University