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临床试验/NCT03686072
NCT03686072已完成不适用

Head of Glaucoma, Clinical Professor

Wenzhou Medical University0 个研究点目标入组 19 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
19
主要终点
number of intraocular pressure (IOP) lowering drugs

研究概览

简要总结

In this prospective study, consecutive patients with advanced PACG and cataract who underwent Phaco-IOL-EGSL were invited to participate.

Inclusion and exclusion criteria Inclusion criteria included: a diagnosis of PACG according to the International Society of Geographical & Epidemiological Ophthalmology (ISGEO) diagnostic criteria,14 visual field score ≥18 calculated (as per the method used in the Advanced Glaucoma Intervention Study [AGIS]),15 treatment with IOP-lowering drugs for more than 3 months, and mild to moderate cataract. Exclusion criteria included: secondary angle-closure glaucoma and previous history of surgery, except laser peripheral iridotomy.

Preoperative and postoperative examinations Preoperative examinations included: best corrected logMAR visual acuity (BCVA), number of intraocular pressure (IOP) lowering drugs, slit lamp and fundus examination, gonioscopy, Goldmann applanation tonometry and ultrasound biomicroscopy (UBM). Visual field tests were conducted with a Humphrey Visual Field Analyzer II.

All patients were reviewed at 1 week, 1 month, 3 months, 6 months and 12 months after surgery. The number of IOP-lowering drugs and IOP was observed and recorded at each follow-up. The extent of peripheral anterior synechiae , the BCVA and the visual field were recorded at 12 months following surgery.

Surgery procedure All patients used IOP-lowering drugs before surgery; IOP was controlled under 21mmHg where possible. If the preoperative IOP was over 40mmHg a preoperative anterior chamber paracentesis was performed. All surgeries were performed by the same experienced surgeon (WP). Intraoperative and postoperative complications were recorded.

In all patients, phacoemulsification was performed first. After implantation of the IOL, an ophthalmic endoscope (OE) probe was inserted into the anterior chamber to visualize the PAS through the main incision and side incision. A viscoelastic agent was injected towards the root of the iris where PAS existed. Then a blunt iris spatula was used to release the areas where PAS remained under direct view with the OE. Complete synechialysis was confirmed under the direct view with the OE at the end of the procedure.

Success criteria Based on the AGIS study, we defined surgical success as follows: (1) Standard A: IOP<14mmHg using none or one type of IOP-lowering drug; (2) Standard B: IOP <18mmHg using none or one type of IOP-lowering drug.

详细描述

Introduction The prevalence of primary angle-closure glaucoma (PACG) is approximately 0.1% of the general population over 40 years of age but up to 1.5% of the Chinese population over 50 years of age. Studies predict that the number of cases of PACG in Asia will increase by 2040.4 Because PACG appears to cause blindness more frequently than primary open-angle glaucoma (POAG), it is considered to be the main cause of binocular glaucoma blindness and reduced quality of life in China. Early diagnosis of PACG is difficult; advanced cases at presentation are not uncommon.

In recent years cataract surgery (phacoemulsification with intraocular lens implantation) combined with goniosynechialysis (Phaco-IOL-GSL) has become more widely used in the treatment of PACG.8-11 Compared with the classic glaucoma filtration surgery, Phaco-IOL-GSL does not involve the creation of a filtering bleb with the need for long-term close follow-up. This is important for patients with poor compliance or difficulty with travel. However, the efficacy and risk of Phaco-IOL-GSL in patients with advanced glaucoma has not been reported. We prospectively performed phacoemulsification combined with intraocular lens implantation combined with endoscopic goniosynechialysis (Phaco-IOL-EGSL) in patients with advanced angle-closure glaucoma, and explored the efficacy and risk of the surgery.

Materials and methods Subjects Our objective was to measure the extent of PAS, number of intraocular pressure(IOP) lowering drugs, IOP, BCVA and visual field before and after surgery in patients with advanced PACG, to investigate the efficacy and safety of Phaco-IOL-EGSL. We also evaluate the correlation between the two groups of data.

In this prospective study, consecutive patients with advanced PACG and cataract who underwent Phaco-IOL-EGSL were invited to participate. The study was approved by the Ethics Committee of the Affiliated Eye Hospital of Wenzhou Medical University and informed consent was obtained from all patients, adhered to the tenets of the Declaration of Helsinki. All patients were treated at the Affiliated Eye Hospital of Wenzhou Medical University between February 2014 and March 2016. A total of 17 subjects (19 eyes) were enrolled in the study. Patients were followed up for 12 months. One patient was lost during follow-up, and 16 subjects (18 eyes) were analyzed in this study. No patient refused to participate in the study.

Inclusion and exclusion criteria Inclusion criteria included: a diagnosis of PACG according to the International Society of Geographical & Epidemiological Ophthalmology (ISGEO) diagnostic criteria,14 visual field score ≥18 calculated (as per the method used in the Advanced Glaucoma Intervention Study [AGIS]), treatment with IOP-lowering drugs for more than 3 months, and mild to moderate cataract. Exclusion criteria included: secondary angle-closure glaucoma and previous history of surgery, except laser peripheral iridotomy.

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

性别
All
接受健康志愿者

入选标准

  • a diagnosis of PACG according to the International Society of Geographical & Epidemiological Ophthalmology (ISGEO) diagnostic criteria,[14] visual field score ≥18 calculated (as per the method used in the Advanced Glaucoma Intervention Study [AGIS]),[15] treatment with IOP-lowering drugs for more than 3 months, and mild to moderate cataract.

排除标准

  • secondary angle-closure glaucoma and previous history of surgery, except laser peripheral iridotomy.

结局指标

主要结局

number of intraocular pressure (IOP) lowering drugs

时间窗: Change from Baseline IOP lowering drugs at 12 months

observed the the number of IOP lowering drugs before and after surgery

visual field

时间窗: Change from Baseline MD of visual field at 12 months

Mean defect(MD)of visual field before and after surgery

The extent of peripheral anterior synechiae (PAS)

时间窗: Change from Baseline PAS at 12 months

observed the the extent of PAS before and after surgery

IOP

时间窗: Change from Baseline IOP at 12 months

IOP before and after surgery

best corrected visual acuity

时间窗: Change from Baseline best corrected visual acuity at 12 months

best corrected visual acuity before and after surgery

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

yin ying zhao

Department of Catract

Wenzhou Medical University

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