Hyman Leslie G, Komaroff Eugene, Heijl Anders, Bengtsson Bo, Leske M Cristina
Department of Preventive Medicine, School of Medicine, Stony Brook University, Health Sciences Center, Stony Brook, New York 11794-8036, USA.
Ophthalmology. 2005 Sep;112(9):1505-13. doi: 10.1016/j.ophtha.2005.03.028.
To evaluate the effect of treatment, visual function, and other factors on vision-targeted health-related quality of life (HRQOL) of patients with early glaucoma.
Randomized clinical trial.
Two hundred fifty-five patients with newly detected open-angle glaucoma and repeatable early visual field (VF) defects, 50 to 80 years old (66% female).
Patients were randomized to receive either betaxolol plus laser trabeculoplasty in eligible eye(s) or no initial treatment and had ophthalmologic examinations every 3 months. A Swedish translation of the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) was self-administered at 2 follow-up visits (3 and 6 years after randomization).
Multiple linear regression analyses determined the effect of treatment and other factors on (1) VFQ-25 composite scores at the first administration and (2) change in scores between administrations.
Two hundred thirty-three patients had 1 NEI VFQ-25 administration and 167 patients had 2 administrations. Internal consistency reliability was high for the composite VFQ-25 score (Cronbach alpha = 0.88) and satisfactory (alpha> or =0.76) for most subscale scores. At the first administration, the composite score was high (88.8+/-11.7). Mean subscale scores were also generally high (98.0-58.3) and were similar for each study group when analyzed separately. Most lower subscale scores were modestly but significantly related to worse visual acuity (VA) or mean deviation (MD) (better eye, r = 0.15-0.35). Composite scores were similar for treated and untreated patients. Lower composite scores were associated with low VA in the better eye (worse than 0.70) and worse perimetric MD (<4.16 decibels) and nuclear lens opacities (Lens Opacities Classification System II grade > or = 2), but not with age, gender, VF progression, intraocular pressure, cardiovascular disease, or hypertension. Between VFQ-25 administrations, larger decreases in the composite score were associated with larger decreases in VA (P<0.05), female gender (P = 0.001), and older age at first administration (P = 0.006). Treatment (assigned at randomization or later in the study) was not associated with change in HRQOL.
Results suggest that absence or delay of treatment did not influence vision-targeted HRQOL in these newly diagnosed glaucoma patients. However, visual function affected vision-targeted quality of life up to 6 years after Early Manifest Glaucoma Trial enrollment.
评估治疗、视觉功能及其他因素对早期青光眼患者以视力为目标的健康相关生活质量（HRQOL）的影响。
随机临床试验。
255例新诊断为开角型青光眼且早期视野（VF）缺损可重复检测的患者，年龄50至80岁（女性占66%）。
患者被随机分为在患眼接受倍他洛尔联合激光小梁成形术或不进行初始治疗，每3个月进行眼科检查。在2次随访时（随机分组后3年和6年）由患者自行填写25项美国国立眼科研究所视觉功能问卷（NEI VFQ - 25）的瑞典语译本。
多元线性回归分析确定治疗及其他因素对（1）首次填写时的VFQ - 25综合评分以及（2）两次填写之间评分变化的影响。
233例患者进行了1次NEI VFQ - 25填写，167例患者进行了2次填写。VFQ - 25综合评分的内部一致性信度较高（Cronbach α = 0.88），大多数子量表评分也令人满意（α≥0.76）。首次填写时，综合评分较高（88.8±11.7）。各子量表平均评分通常也较高（98.0 - 58.3），单独分析时各研究组相似。大多数较低的子量表评分与较差的视力（VA）或平均缺损（MD）呈中度但显著相关（较好眼，r = 0.15 - 0.35）。治疗组和未治疗组患者的综合评分相似。较低的综合评分与较好眼的低视力（低于0.70）、较差的视野平均缺损（<4.16分贝）和核性晶状体混浊（晶状体混浊分级系统II级≥2）相关，但与年龄、性别、视野进展、眼压、心血管疾病或高血压无关。在两次VFQ - 25填写之间，综合评分下降幅度较大与视力下降幅度较大（P<0.05）、女性（P = 0.001）以及首次填写时年龄较大（P = 0.006）相关。治疗（随机分组时或研究后期分配）与HRQOL变化无关。
结果表明，在这些新诊断的青光眼患者中，治疗的缺失或延迟并未影响以视力为目标的HRQOL。然而，在早期显性青光眼试验入组后长达6年的时间里，视觉功能影响了以视力为目标的生活质量。
