Clinical Study of Laser Peripheral Iridoplasty With Different Laser Wavelengths
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Change of anterior chamber angle(AA)
研究概览
简要总结
Glaucoma is the second cause of blindness worldwide. Laser peripheral iridoplasty (LPI) is a simple and effective treatment for angle closure glaucoma. LPI can widen or reopen an existing angle close or angle adhesion in order to reduce the risk of attack of the angle closure glaucoma. However, there are very little research on the laser site, laser wavelengths, laser energy and laser spot intervals. The purpose of this study is to determine the optimum laser wavelengths of LPI.
详细描述
Glaucoma is the second cause of blindness worldwide. Laser peripheral iridoplasty (LPI) is a simple and effective treatment for angle closure glaucoma. LPI can widen or reopen an existing angle close or angle adhesion in order to reduce the risk of attack of the angle closure glaucoma. However, there are very little research on the laser site, laser wavelengths, laser energy and laser spot intervals.Conventional LPI uses wavelength 532nm laser. However, our preclinical studies have found that the laser penetration of the laser wavelength 561nm is stronger than that of the laser wavelength 532nm. It can produce a stronger contraction effect.
The purpose of this study is to determine the optimum laser wavelengths of LPI. Baseline and 7days, 1 month, 3 months after LPI, the structure of anterior chamber, including angle anterior chamber depth(ACD), angle of anterior chamber (AA), anterior chamber angle opening distance 750(AOD750) are measured with ultrasound biomicroscopy. Baseline and 7days, 1 month, 3 months after LPI, the outflow resistance of aqueous humor are evaluated with C value. Baseline and 1hour, 1days, 3day, 7days, 1 month, 3 months after LPI, intraocular pressure are measured with Goldmann tonometry. Baseline and 3 months after LPI, retinal nerve layer thickness and the optic disc cup disc ratio are measure with optical coherence tomography.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with primary angle closure suspect (PACS), primary angle closure (PAC) or primary angle closure glaucoma (PACG).
- •PACS is diagnosed in eyes with an occludable angle but no other abnormality.
- •PAC is diagnosed in eyes with an occludable angle, normal optic discs and visual fields and any of the following: raised IOP (>19 mm Hg), PAS, pigment smearing in the superior angle, or sequelae of acute angle closure (iris whirling or glaucomatous fleck).
- •PACG is diagnosed in eyes with an occludable angle and glaucomatous optic neuropathy. Evidence of glaucomatous optic neuropathy is defined as a cup: disc ratio (CDR) of >0.7 or >0.2 CDR asymmetry.
- •An occludable angle is defined as one in which three quarters of the posterior pigmented trabecular meshwork is not visible on viewing with a Goldmann two mirror lens in the primary position of gaze without indentation.
排除标准
- •Patients with previous ocular surgery, and those with secondary angle closure, such as lens intumescence or subluxation, iris neovascularisation and a history of uveitis.
- •Patients who have systemic contraindications to medical therapy (including renal impairment, sulfur allergy, asthma and heart failure), pre-existing corneal opacities obstructing laser access to more than one quadrant of the peripheral iris and single-eyed patients are also excluded.
结局指标
主要结局
Change of anterior chamber angle(AA)
时间窗: Baseline and 3 months after LPI.
Anterior chamber angle (AA) is measured with ultrasound biomicroscopy.
次要结局
- Change of anterior chamber angle opening distance 750(AOD750)(Baseline and 3 months after LPI.)
- Change of anterior chamber depth(ACD)(Baseline and 3 months after LPI.)
- Change of C value(Baseline and 7days, 1 month, 3 months after LPI.)
- Change of retinal nerve layer thickness(Baseline and 3 months after LPI.)
- Change of optic disc cup disc ratio(Baseline and 3 months after LPI.)
- Change of mean sensitivity(Baseline and 3 months after LPI.)
- Change of scotoma(Baseline and 3 months after LPI.)
- Change of intraocular pressure (IOP)(Baseline and 1hour, 1days, 3day, 7days, 1 month, 3 months after LPI.)
- Change of mean defect(Baseline and 3 months after LPI.)
研究者
Maosong Xie
Principal Investigator
First Affiliated Hospital of Fujian Medical University