Detection and measurement of clinically meaningful visual field progression in clinical trials for glaucoma

Glaucomatous visual field progression has both personal and societal costs and therefore has a serious impact on quality of life. At the present time, intraocular pressure (IOP) is considered to be the most important modifiable risk factor for glaucoma onset and progression. Reduction of IOP has been repeatedly demonstrated to be an effective intervention across the spectrum of glaucoma, regardless of subtype or disease stage. In the setting of approval of IOP-lowering therapies, it is expected that effects on IOP will translate into benefits in long-term patient-reported outcomes. Nonetheless, the effect of these medications on IOP and their associated risks can be consistently and objectively measured. This helps to explain why regulatory approval of new therapies in glaucoma has historically used IOP as the outcome variable. Although all approved treatments for glaucoma involve IOP reduction, patients frequently continue to progress despite treatment. It would therefore be beneficial to develop treatments that preserve visual function through mechanisms other than lowering IOP. The United States Food and Drug Administration (FDA) has stated that they will accept a clinically meaningful definition of visual field progression using Glaucoma Change Probability criteria. Nonetheless, these criteria do not take into account the time (and hence, the speed) needed to reach significant change. In this paper we provide an analysis based on the existing literature to support the hypothesis that decreasing the rate of visual field progression by 30% in a trial lasting 12–18 months is clinically meaningful. We demonstrate that a 30% decrease in rate of visual field progression can be reliably projected to have a significant effect on health-related quality of life, as defined by validated instruments designed to measure that endpoint.     

倍频视野计对开角型青光眼正常半侧视野的检测结果

目的　了解倍频视野计 (frequency doublingperimetry ,FDP)检测早期青光眼视野异常的能力。方法　对Humphery视野计检测结果仅为半侧视野异常的 4 9例 (49只眼 )开角型青光眼患者 ,进行FDP(C 2 0阈值程序检测 )及海德堡视网膜断层扫描仪 (Heidelbergretinaltomography ,HRT)检测。根据检测结果 ,将患者分成FDP正常组及异常组 ;再将两组的HRT检测参数进行比较分析。结果FDP检测的平均光敏感度与HRT视野检测结果的平均偏差有显著相关性 (r =0 5 83,P <0 0 0 0 )。Humphery检测的异常半侧视野 ,FDP检测显示正常的仅占 2 0 % (1/ 4 9)。而Humphery检测的正常半侧视野 ,FDP检测显示异常的为 4 0 8% (2 0 / 4 9) ,与其相对应视乳头的HRT检测参数相比 ,FDP异常组的视杯面积和杯 /盘面积比值较FDP正常组的检测值大 (t=2 36 0和 2 4 39,P <0 0 5 ) ,而盘缘面积和盘缘容积则较FDP正常组小 (t=2 32 9和 2 5 79,P <0 0 5 )。结论　FDP不仅能检测出HRT发现的视野缺损 ,而且能显示HRT尚未能检测出的早期青光眼视野异常 ;FDP检测结果与HRT检测参数显示的青光眼性视乳头变化相一致。     

蓝黄视野检查与RTA后极部视网膜厚度的相关研究

目的探讨视网膜厚度分析仪获得的后极部视网膜厚度丢失程度与蓝黄视野缺损的相关性。方法对25例37眼可疑青光眼;17例26眼早期青光眼;10例16眼中晚期原发性开角型青光眼患者分别进行标准视野检查、蓝黄视野检查、并用RTA获得后极部视网膜地形图。对获得的W/W、B/Y、RTA后极部视网膜厚度损伤程度分别进行等级评分,用Spearman等级相关来评价三种检测方法的相关性,并用直线回归分析评价RTA预测青光眼损伤程度的能力。结果(1)RTA测得的后极部视网膜厚度丢失程度与W/W视野检查损伤程度的相关性相对较小(r=0.601),但回归系数具有显著的统计意义(P<0.001)。(2)RTA测得的后极部视网膜厚度丢失程度与B/Y视野检查损伤程度有较高的相关性(r=0.864)。相应的回归系数具有显著的统计意义(P<0.001)。结论RTA后极部视网膜厚度测量是一种新的评估青光眼视神经损伤的途径,与蓝黄视野检查缺损程度具有较好的相关性,两种方法结合对青光眼的早期诊断具有重要的意义。     

晚期青光眼患者视野检查的可靠性分析

目的本文探讨晚期青光眼与早中期青光眼患者视野检测的可靠性是否存在显著性差异。方法以2002年4月至2003年12月随诊于我科的临床确诊为青光眼的患者作为研究对象,应用OCTOPUS101型视野计中G2/TOP程序对双眼进行视野检测。以每位患者有一次以上视野检查经历及裸眼视力≥0.5,瞳孔直径大于2.5mm作为入选标准。共157只眼(90位患者)入选;年龄25岁到79岁,男性29人、女性61人。结果以平均缺损指数(MD,meandefect)分组:MD≥15dB为晚期青光眼组;MD<15dB为早中期青光眼组。MD≥15dB组RF值35.73±3.69,显著高于MD<15dB组5.14±0.73(P<0.01);根据RF值进行分组:RF>15%为RF异常组;RF≤15%为RF正常组,RF异常组的MD值8.64±1.08显著高于RF正常组4.38±0.38(P<0.01)。晚期青光眼组患者假阴性率远高于早中期青光眼组。结论晚期青光眼患者视野检查的可靠性因子(RF)与早中期患者相比有显著差异,在视野损伤严重的患者,高RF值并不一定代表患者视野检查的可靠性差,相反,当青光眼损伤到一定程度,RF值随之增大,可能与损伤程度有关。高RF值来源于高的假阴性率,青光眼的加重导致假阴性率的增高。     

后发性白内障切开孔径大小对视野的影响

目的　探讨治疗后发性白内障 2mm和 4mm不同切开孔径对视野的影响 ,并分析其相关因素。方法　将 4 0例白内障摘除人工晶状体植入术后晶状体后囊膜Ⅱ级混浊患者随机均分为 2mm切开孔径组和 4mm切开孔径组 ,行掺钕钇铝石榴石激光晶状体后囊膜切开术后 1 5个月检查中心 30°和周边 6 0°视野。以 2 1例白内障摘除人工晶状体植入术后晶状体后囊膜透明患者 (透明组 )为对照 ,对各组视野检查指标结果进行分析。结果　 2mm切开孔径组视野检查的平均偏差为 - 8 6 5± 3 96 ,样本标准差为 5 71± 2 6 0 ,中心 10°总光敏感度值为 2 89 30± 4 3 6 3,周边 6 0°总光敏感度值为 5 5 8 2 0±197 2 7,与透明组比较 ,差异均有非常显著意义 (P <0 0 0 1)。 4mm切开孔径组视野检查的平均偏差为- 4 0 8± 2 73,样本标准差为 3 0 5± 2 13,中心 10°总光敏感度值为 336 5 4± 34 32 ,周边 6 0°总光敏感度值为 94 5 95± 2 4 4 74 ,与透明组比较 ,差异均无显著意义 (P >0 0 5 )。结论　治疗后发性白内障 2mm切开孔径虽可获得较佳视力 ,但对视野影响较大 ,表现为弥漫性光敏感度下降和视岛不规则局限性压陷 ;而 4mm切开孔径对视野的影响较小 ,为较佳的晶状体后囊膜切开直径。     

Detection of chromatic deviations from white across the human visual field

We studied how much blue, green, or red light had to be added to or subtracted from white to obtain veridical hue perception (blue, green, red, or their complementary colours) at various locations in the temporal visual field. The CIE 1931 (x, y) chromaticity coordinates corresponding to a veridical hue perception were subtracted from the chromaticity coordinates of the white (0.35, 0.35) in order to obtain the threshold differences (dx, dy) in chromaticity coordinates. When stimulus size was constant at all visual field locations, dx and dy changed with eccentricity. However, when the stimulus was M-scaled by magnifying its size with increasing eccentricity in inverse proportion to the lowest local sampling density across the human retina (cones and ganglion cells at eccentricities 0-10 and above 10 deg, respectively), dx and dy remained constant at all eccentricities.     

趋势导向视野检查法与常规阈值视野检查法的对比研究

目的 评价趋势导向视野检查法(tendency-oriented perimetry, TOP)在青光眼视功能检测中的应用价值。 方法 利用Octopus 101全自动视野计分别对20名正常人的20只正常眼、32例原发性开角型青光眼(primary open angle glaucoma, POAG)患者的32只患眼和14例可疑POAG患者的14只眼分别进行常规阈值视野检查(Normal/Normal程序)和TOP视野检查(TOP/Normal程序)。所有受检眼在2周内再次分别进行常规阈值视野检查和TOP视野检查。将两种视野检查的结果、视野检查指数、点对点阈值变异及视野缺损点数进行比较和分析。 结果 TOP视野检查正常人的阴性检出率为90%，POAG的阳性检出率为75%，其中检测中晚期POAG的阳性检出率达100％。2种视野检查的视野指数呈明显正相关，平均敏感度(mean sensitivity, MS)的相关系数为0.9335，平均缺损(mean defect, MD)的相关系数为0.9189，偏离缺失(loss variance, LV)的相关系数为0.9621。点对点阈值变异和视野缺损点数TOP视野检查结果略高于常规阈值视野检查结果，但二者间差异均无显著性的意义(P＝0.2019，P＝0.4448)。 结论 TOP视野检查指数与常规阈值视野检查指数呈明显正相关，其检测中晚期POAG的敏感性及可重复性高。 (中华眼底病杂志, 2002, 18: 169-272)     

Octopus 101自动视野计GKP模块在眼科的应用

目的 评价Octopus101视野计动态视野GKP (Goldmann Kinetic Perimetry)模块在眼科的应用.方法 对已确诊明确有视野缺损患者67例(107只眼)行动态视野GKP模块检查;其中青光眼24例(38只眼)、前部缺血性视神经病变18例(21只眼)、偏盲25例(48只眼),并对同一患者动、静态视野配对图进行一致性分析;同时检测GKP模块的重复性.结果 67例患者中男性27例,女性40例;平均年龄(50.7±12.7)岁(18～82岁);视力范围在0.3～1.2之间;青光眼组、前部缺血性视神经病变组、偏肓组平均动态视野GKP检查时间分别为(8.43±2.21) min、(8.52±1.49) min、(6.89±2.06)min;各组Ⅲ4e和Ⅰ4e两种视标参数等视线面积相比差异具有统计学意义(均P＜0.01);同一患者动、静态视野图形匹配在青光眼组76.32％ (29/38);前部缺血性视神经病变组83.33％ (15/18);偏盲组100％ (48/48);Ⅲ4e和Ⅰ4e两种视标参数在两次重复检查(GKP1,GKP2)等视线面积差异均无统计学意义(分别P=0.68,P=0.59),两次重复检查结果相关性好(Spearman线性相关分析,均P＜0.001).结论 Octopus101 GKP模块可应用于青光眼、前部缺血性视神经病变、偏盲患者的诊断和定量随访,并重复性好.     

Short-wavelength sensitive visual field loss in patients with clinically significant diabetic macular oedema

Summary The aim of the study was to compare the sensitivity of short-wavelength and conventional automated static threshold perimetry for the psychophysical detection of abnormality in patients with clinically significant diabetic macular oedema. The sample comprised 24 patients with clinically significant diabetic macular oedema (mean age 59.75 years, range 45–75 years). One eye of each patient was selected. Exclusion criteria included the presence of lenticular opacity. The sensitivity of the macular visual field of each patient was determined with programme 10–2 of the Humphrey Field Analyser on two occasions, using both short-wavelength and conventional stimulus parameters; the results of the second session were analysed to minimise learning effects. A pointwise horizontal hemifield asymmetry analysis was derived for short-wavelength perimetry (thereby negating the influence of pre-receptoral absorption); the pointwise pattern deviation probability plot was analysed for conventional perimetry. Abnormality was defined as 3 or more contiguous stimulus locations with negative asymmetries (short-wavelength) or reduced sensitivity values (conventional) that resulted in a statistical probability level of p less than 0.05. The fields of 8 patients were abnormal as assessed by conventional perimetry while all were classified as abnormal using short-wavelength perimetry. In the 8 patients who exhibited both abnormal conventional and abnormal short-wavelength perimetry results, the extent of field loss was generally greater using short-wavelength perimetry. The position of the localised field loss (i. e. as distinct from field loss that was generalised across the visual field) assessed by short-wavelength perimetry corresponded with the clinical mapping of the area of diabetic macular oedema but the extent of this loss was generally greater than that suggested by clinical assessment. Short-wavelength automated perimetry offers improved sensitivity for the psychophysical detection of clinically significant diabetic macular oedema. [Diabetologia (1998) 41: 918–928] Received: 5 January 1998 and in revised form: 13 March 1998     

Octopus 123视野计诊断早中期青光眼的价值

作者用Octopus123全自动视野计的G1X程序及Goldmann视野计（GP），对60只青光眼进行了视野研究。GP采用湖崎分期。结果发现，平均缺损度（MD）和矫正缺损变异度（CLV）的异常增高，与GP的视野缺损严重度一致。根据Be-bie曲线所见，作者建议将曲线分为平坦型、陡峭型及混合型3种。极早期青光眼的G1X视野以弥散缺损为主，Bebie曲线表现为平坦型（占78％）。作者对其机理进行了讨论。