Study on the Relationship Between Macular Pigment Optical Density and Primary Angle-closure Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Macular Pigment Optical Density（MPOD）Measurement
研究概览
简要总结
Glaucoma is the leading cause of irreversible blindness in the world, and primary angle-closure glaucoma (PACG) is the most important type of glaucoma in Asia. Primary angle closure disease (PACD) is a group of diseases related to PACG, and the pathogenesis is still unclear. Macular pigment has the functions of filtering short-wavelength waves and anti-oxidation, which are related to visual function. Previous studies have found that the macular pigment density (MPOD) is significantly reduced in primary open-angle glaucoma. This project uses the single-wavelength reflection method to measure MPOD, observes the characteristics of PACD and the normal control group's changes in retinal MPOD, and explains the relationship between PACD's MPOD changes and angle-closure glaucoma optic nerve damage
详细描述
Observation index： Visual acuity，Intraocular pressure，Ophthalmoscope，MPOD，Visual field and OCT.
Inspection parameters of OCT：
- Retinal nerve fiber layer thickness
- Ganglion cell complex thickness
- Mean thickness of the central retina
- Mean defect
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Experimental group：
- •(1) According to the diagnostic criteria of PACD
- •(2)History of peripheral iridectomy or trabeculectomy
- •(3)Over 40
- •(4)Phakic eyes
- •(5)Intraocular pressure is less than 21mmhg, more than one week
- •(6)Eyes with clear optical media.
- •Control group：
- •(1)No history of glaucoma and other eye diseases
- •(2)Phakic eyes
- •(3)Over 40
- •(4)Intraocular pressure10~21mmHg
排除标准
- •(1)History of corneal diseases
- •(2)History of eye tumor or other ophthalmic surgery
- •(3)Cataract
- •(4)Taking supplements containing lutein within 6 months
- •(5)Snellen's visual acuity was less than 6 / 20，the diopter is beyond ± 6 degrees
结局指标
主要结局
Macular Pigment Optical Density（MPOD）Measurement
时间窗: 3 months after surgery
A one-wavelength fundus reflectance method (Visucam 200; Carl Zeiss Meditec) was used for the detection of MPOD as previously described. The right or left eye was randomly selected for measurement. The parameters and profiles of MPOD in a 7-degree eccentricity that corresponded to a 4 mm diameter were evaluated and output. Parameters included max and mean optical density (OD), volume, and area. MaxOD and MeanOD with units "d.u." (initial of density units) were used for the analyses.
Retinal nerve fiber layer thickness
时间窗: 3 months after surgery
Detection by optical coherence tomography (OCT). Circumpapillary RNFL scans were obtained using the standard 3.4 mm 12-degree circumpapillary nerve fiber layer scan protocol.We recorded superior, inferior, nasal, temporal, and total RNFL thickness.
Visual Field Test
时间窗: 3 months after surgery
The visual field test uses the 30-2 Threshold Test on the Humphrey Visual Field Analyzer.According to the mean deviation (MD) values generated by the software, three groups of disease severity were classified: the mild group with MD \> -6 dB, the moderate group with MD between -6 and -12 dB, and the severe group with MD \< -12 dB
Mean central retina thickness
时间窗: 3 months after surgery
Detection by optical coherence tomography (OCT). CRT thickness was defined as distance between the internal limiting membrane and the inner edge of the retinal pigment epithelium.
Mean outer retinal thickness
时间窗: 3 months after surgery
Outer retinal (OR) thickness was calculated by subtracting GCC thickness from CRT.
Ganglion cell complex (GCC)thickness
时间窗: 3 months after surgery
Detection by optical coherence tomography (OCT). The distance from the internal limiting membrane and outer edge of the outer plexiform layer was defined as GCC thickness.
次要结局
- Visual acuity(3 months after surgery)
- Intraocular pressure(3 months after surgery)
- Cup/ Disk ( C/ D）(3 months after surgery)