Edward Hines, Jr. Veterans Affairs Hospital, Hines, IL, USA.
Ophthalmic Physiol Opt. 2012 Nov;32(6):461-71. doi: 10.1111/j.1475-1313.2012.00933.x. Epub 2012 Sep 7.
To compare the effectiveness of low vision rehabilitation (LVR) and basic low vision (LV) in a single masked multicentre randomised controlled trial (RCT).
Three hundred and thirty patients eligible for US. Veterans Affairs (VA) healthcare services with primary eye diagnosis (better-seeing eye) of macular disease and best-corrected distance visual acuity of 0.40-1.00 logMAR (6/15 to 6/60 or 20/50 to 20/200 Snellen) are being enrolled at seven VA facilities. All participants receive an optometric LV examination; and they are eligible to receive the same LV devices that are provided without charge. In LVR, a LV therapist dispenses devices and provides 2 or 3 (1½ to 2½ h) therapy sessions with assigned homework to teach effective use of remaining vision and LV devices. Contact time with the therapist depends upon the devices prescribed and the patient's progress in learning the skills that are taught. In basic LV, devices are dispensed by the optometrist without LV therapy. Contact time for dispensing is one hour or less depending on LV devices prescribed. The primary outcome measure is a comparison of the changes in visual reading ability (estimated from patients' difficulty ratings of reading items on the VA LV VFQ-48 questionnaire) between the treatment and control arms from pre-intervention baseline to 4 months (2 months after completion of treatment). Secondary outcome measures are changes in overall visual ability, visual ability domain scores calculated from subsets of items (mobility, visual information processing and visual motor skills), Short Form-36, and Minnesota Low Vision Reading Test scores. Cost-effectiveness analysis will be conducted using VA LV VFQ-48 scores and QALYS computed from EuroQol scores.
A total of 137 patients representing 41.5% of the study target of 330 patients were randomised from October 2010 to March 2012. Among those 137 patients, mean age was 80.2 (S.D. ± 9.9) years at enrollment; 97.1% of the patients were males; 94.2% were white. Mean best corrected VA was 0.65 (S.D. ± 0.3) logMAR (approximately Snellen 6/27 or 20/90) at baseline.
LOVIT II is the first multicentre RCT comparing the effectiveness and cost-effectiveness of LVR and basic LV for patients with macular diseases and near normal or moderate levels of visual impairment.
在一项单盲、多中心、随机对照试验（RCT）中比较低视力康复（LVR）和基本低视力（LV）的效果。
330 名符合美国退伍军人事务部（VA）医疗服务条件的患者，其主要眼部诊断（好眼）为黄斑疾病，最佳矫正远距视力为 0.40-1.00 logMAR（6/15 至 6/60 或 20/50 至 20/200 Snellen），在七个 VA 机构登记。所有参与者均接受眼科 LV 检查；并符合条件获得免费提供的相同 LV 设备。在 LVR 中，一名 LV 治疗师发放设备并提供 2 或 3 次（1.5 至 2.5 小时）治疗课程，安排家庭作业，教授有效利用剩余视力和 LV 设备的技能。与治疗师的联系时间取决于所开处方的设备和患者学习所教授技能的进度。在基本 LV 中，由视光师发放设备，无需 LV 治疗。根据所开 LV 设备，分配时间为 1 小时或更短。主要结局测量是治疗组和对照组从干预前基线到 4 个月（治疗完成后 2 个月）之间视觉阅读能力（根据 VA LV VFQ-48 问卷中患者阅读项目难度评分估计）变化的比较。次要结局测量是整体视觉能力、从项目子集（移动性、视觉信息处理和视觉运动技能）计算的视觉能力域评分、SF-36 和明尼苏达州低视力阅读测试的变化。使用 VA LV VFQ-48 评分和从 EuroQol 评分计算的 QALYS 进行成本效益分析。
2010 年 10 月至 2012 年 3 月，共有 137 名患者（占 330 名研究目标患者的 41.5%）随机分组。在这 137 名患者中，平均年龄为 80.2（S.D. ± 9.9）岁，97.1%的患者为男性，94.2%为白人。基线时平均最佳矫正视力为 0.65（S.D. ± 0.3）logMAR（大约为 Snellen 6/27 或 20/90）。
LOVIT II 是第一项比较黄斑疾病和接近正常或中度视力障碍患者的 LVR 和基本 LV 效果和成本效益的多中心 RCT。
