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退伍军人事务部低视力干预试验(LOVIT)的结果。

Outcomes of the Veterans Affairs Low Vision Intervention Trial (LOVIT).

作者信息

Stelmack Joan A, Tang X Charlene, Reda Domenic J, Rinne Stephen, Mancil Rickilyn M, Massof Robert W

机构信息

Blind Rehabilitation Center, Edward E. Hines Jr Veterans Affairs Hospital, Hines, Illinois 60141, USA.

出版信息

Arch Ophthalmol. 2008 May;126(5):608-17. doi: 10.1001/archopht.126.5.608.

DOI:10.1001/archopht.126.5.608
PMID:18474769
Abstract

OBJECTIVE

To evaluate the effectiveness of a low-vision rehabilitation program.

METHODS

A multicenter randomized clinical trial was conducted from November 2004 to November 2006 with a 4-month follow-up. A total of 126 patients were included, 98% of whom were white and male. The patients were referred from eye or low-vision clinics and blind rehabilitation centers with a visual acuity in the better-seeing eye worse than 20/100 and better than 20/500 and were eligible for Veterans Affairs (VA) services. Telephone interviews of patients were conducted in their homes before and after participation in an outpatient low-vision program at a VA medical care facility or a (waiting list) control group. The interviewer administering questionnaires by telephone was masked to patients' assignments. Interventions included low-vision examination, counseling, and prescription and provision of low-vision devices and 6 weekly sessions provided by a low-vision therapist to teach use of assistive devices and adaptive strategies to perform daily living tasks independently.

MAIN OUTCOME MEASURE

Change in patients' visual reading ability estimated from participant responses to the Veterans Affairs Low-Vision Visual Functioning Questionnaire (LV VFQ-48) reading items completed at baseline compared with 4 months after enrollment for the treatment and control groups. The secondary outcomes were changes in other visual ability domains (mobility, visual information processing, visual motor skills) and overall visual ability from baseline to 4 months estimated from VA LV VFQ-48 difficulty ratings for subsets of items.

RESULTS

The treatment group demonstrated significant improvement in all aspects of visual function compared with the control group. The difference in mean changes was 2.43 logits (95% confidence interval [CI], 2.07-2.77; P < .001; effect size, 2.51) for visual reading ability; 0.84 logit (95% CI, 0.58-1.10; P < .001; effect size, 1.14) for mobility; 1.38 logits (95% CI, 1.15-1.62; P < .001; effect size, 2.03) for visual information processing; 1.51 logits (95% CI, 1.22-1.80; P < .001; effect size, 1.82) for visual motor skills; and 1.63 logits (95% CI, 1.40-1.86; P < .001; effect size, 2.51) for overall visual function.

CONCLUSION

The program effectively provided low-vision rehabilitation for patients with macular diseases. APPLICATIONS TO CLINICAL PRACTICE: At least 10 hours of low-vision therapy, including a home visit and assigned homework to encourage practice, is justified for patients with moderate and severe vision loss from macular diseases. Because the waiting-list control patients demonstrated a decline in functional ability, low-vision services should be offered as early as possible.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00223756.

摘要

目的

评估一项低视力康复计划的效果。

方法

于2004年11月至2006年11月进行了一项多中心随机临床试验,并进行了4个月的随访。共纳入126例患者,其中98%为白人男性。这些患者由眼科或低视力诊所及盲人康复中心转诊而来,其较好眼的视力低于20/100且高于20/500,并有资格享受退伍军人事务部(VA)的服务。在患者参与VA医疗设施的门诊低视力计划之前和之后,在其家中对患者进行电话访谈,同时设置了(等待名单)对照组。通过电话管理问卷的访谈者对患者的分组情况不知情。干预措施包括低视力检查、咨询、低视力设备的处方和提供,以及由低视力治疗师提供6次每周一次的课程,教授辅助设备的使用和执行日常生活任务的适应性策略,以实现独立生活。

主要结局指标

根据治疗组和对照组患者在基线时以及入组4个月后完成的退伍军人事务部低视力视觉功能问卷(LV VFQ - 48)阅读项目的回答,评估患者视觉阅读能力的变化。次要结局指标是根据VA LV VFQ - 48项目子集的难度评级,评估从基线到4个月其他视觉能力领域(移动性、视觉信息处理、视觉运动技能)的变化以及整体视觉能力的变化。

结果

与对照组相比,治疗组在视觉功能的各个方面均有显著改善。视觉阅读能力的平均变化差异为2.43对数单位(95%置信区间[CI],2.07 - 2.77;P <.001;效应大小,2.51);移动性方面为0.84对数单位(95% CI,0.58 - 1.10;P <.001;效应大小,1.14);视觉信息处理方面为1.38对数单位(95% CI,1.15 - 1.62;P <.001;效应大小,2.03);视觉运动技能方面为1.51对数单位(95% CI,1.22 - 1.80;P <.001;效应大小,1.82);整体视觉功能方面为1.63对数单位(95% CI,1.40 - 1.86;P <.001;效应大小,2.51)。

结论

该计划有效地为黄斑疾病患者提供了低视力康复服务。临床实践应用:对于因黄斑疾病导致中度和重度视力丧失的患者,至少10小时的低视力治疗是合理的,包括家访和布置家庭作业以鼓励练习。由于等待名单对照组患者的功能能力出现下降,应尽早提供低视力服务。

试验注册

clinicaltrials.gov标识符:NCT00223756。

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