Search

Importance Randomized clinical trials are needed to compare effectiveness and cost-effectiveness of different low-vision (LV) programs. Objective To determine the value of adding LV rehabilitation with a therapist compared with LV services without intervention. Design, Setting, and Participants A randomized clinical trial was conducted from September 27, 2010, to July 31, 2014, of 323 veterans with macular diseases and best-corrected distance visual acuity (BCDVAbetter-eye) of 20/50 to 20/200. Masked interviewers administered questionnaires by telephone before and after LV treatment. Using an intention-to-treat design, participants were randomized to receive LV devices with no therapy or LV devices with a rehabilitation therapist providing instruction and homework on the use of LV devices, eccentric viewing, and environmental modification. Visual ability was measured in dimensionless log odds units (logits) (0.14-logit change in visual ability corresponds to ability change expected from a 1-line change in visual acuity). Interventions Low-vision devices without therapy and LV devices with therapy. Main Outcomes and Measures Comparison of changes (baseline to 4 months) in overall visual ability and in 4 functional domains (reading, visual information, visual motor, and mobility) estimated from responses to the Veterans Affairs Low Vision Visual Functioning Questionnaire (higher scores indicates more ability or less difficulty in performing activities), and comparison of MNREAD changes (baseline to end of treatment) in maximum reading speed, critical print size, and reading acuity (higher number indicates lower visual acuity). Results Of the 323 participants, 314 were male (97.2%); mean (SD) age, 80 (10.5) years. Basic LV was effective in improving visual ability. However, the LV rehabilitation group improved more in all visual function domains except mobility. Differences were 0.34-logit reading (95% CI, 0.0005 to 0.69; P = .05), 0.27-logit visual information (95% CI, 0.01 to 0.53; P = .04), 0.37-logit visual motor (95% CI, 0.08 to 0.66; P = .01), and 0.27-logit overall (95% CI, 0.06 to 0.49; P = .01). For MNREAD measures, there was more improvement in reading acuity (difference, −0.11 logMAR, 95% CI, −0.15 to −0.07; P P = .005), but not critical print size for the LV rehabilitation group (−0.06 logMAR; 95% CI, −0.12 to 0.002; P = .06). In stratified analyses, the LV rehabilitation group with BCDVAbetter-eye worse than 20/63 to 20/200 improved more in visual ability (reading, visual motor, and overall). Differences were 0.56-logit reading ability (95% CI, 0.08-1.04; P = .02), 0.40-logit visual motor (95% CI, 0.03-0.78; P = .04), 0.34-logit overall (95% CI, 0.06-0.62; P = .02). There was no significant difference between treatment groups for those with BCDVAbetter-eye of 20/50 to 20/63. Conclusions and Relevance Both basic LV alone and combined with LV rehabilitation were effective, but the added LV rehabilitation increased the effect only for patients with BCDVAbetter-eye worse than 20/63 to 20/200. Basic LV services may be sufficient for most LV patients with mild visual impairment. Trial Registration clinicaltrials.gov Identifier:NCT00958360

Importance To facilitate comparative clinical outcome research in low vision rehabilitation, we must use patient-centered measurements that reflect clinically meaningful changes in visual ability. Objective To quantify the effects of currently provided low vision rehabilitation (LVR) on patients who present for outpatient LVR services in the United States. Design, Setting, and Participants Prospective, observational study of new patients seeking outpatient LVR services. From April 2008 through May 2011, 779 patients from 28 clinical centers in the United States were enrolled in the Low Vision Rehabilitation Outcomes Study. The Activity Inventory, a visual function questionnaire, was administered to measure overall visual ability and visual ability in 4 functional domains (reading, mobility, visual motor function, and visual information processing) at baseline and 6 to 9 months after usual LVR care. The Geriatric Depression Scale, Telephone Interview for Cognitive Status, and Medical Outcomes Study 36-Item Short-Form Health Survey physical functioning questionnaires were also administered to measure patients’ psychological, cognitive, and physical health states, respectively, and clinical findings of patients were provided by study centers. Main Outcomes and Measures Mean changes in the study population and minimum clinically important differences in the individual in overall visual ability and in visual ability in 4 functional domains as measured by the Activity Inventory. Results Baseline and post-rehabilitation measures were obtained for 468 patients. Minimum clinically important differences (95% CIs) were observed in nearly half (47% [95% CI, 44%-50%]) of patients in overall visual ability. The prevalence rates of patients with minimum clinically important differences in visual ability in functional domains were reading (44% [95% CI, 42%-48%]), visual motor function (38% [95% CI, 36%-42%]), visual information processing (33% [95% CI, 31%-37%]), and mobility (27% [95% CI, 25%-31%]). The largest average effect size (Cohen d = 0.87) for the population was observed in overall visual ability. Age ( P = .006) was an independent predictor of changes in overall visual ability, and logMAR visual acuity ( P = .002) was predictive of changes in visual information processing. Conclusions and Relevance Forty-four to fifty percent of patients presenting for outpatient LVR show clinically meaningful differences in overall visual ability after LVR, and the average effect sizes in overall visual ability are large, close to 1 SD.

IMPORTANCE: Most patients with low vision are elderly and have functional limitations from other health problems that could add to the functional limitations caused by their visual impairments. OBJECTIVE: To identify factors that contribute to visual ability measures in patients who present for outpatient low vision rehabilitation (LVR) services. DESIGN, SETTING, AND PARTICIPANTS: As part of a prospective, observational study of new patients seeking outpatient LVR, 779 patients from 28 clinical centers in the United States were enrolled in the Low Vision Rehabilitation Outcomes Study (LVROS) from April 25, 2008, through May 2, 2011. The Activity Inventory (AI), an adaptive visual function questionnaire, was administered to measure overall visual ability and visual ability in 4 functional domains (reading, mobility, visual motor function, and visual information processing) at baseline before LVR. The Geriatric Depression Scale, Telephone Interview for Cognitive Status, and Medical Outcomes Study 36-Item Short-Form Health Survey physical functioning questionnaires were also administered to measure patients’ psychological, cognitive, and physical health states, respectively. MAIN OUTCOMES AND MEASURES: Predictors of visual ability and functional domains as measured by the AI. RESULTS: Among the 779 patients in the LVROS sample, the mean age was 76.4 years, 33% were male, and the median logMAR visual acuity score was 0.60 (0.40–0.90 interquartile range). Correlations were observed between logMAR visual acuity and baseline visual ability overall (r = −0.42) and for all functional domains. Visual acuity was the strongest predictor of visual ability (P < .001) and reading ability (P < .001) and had a significant independent effect on the other functional domains. Physical ability was independently associated with (P < .001) overall visual ability as well as mobility and visual motor function. Depression had a consistent independent effect (P < .001) on overall visual ability and on all functional domains, whereas cognition had an effect on only reading and mobility (P < .001). CONCLUSIONS AND RELEVANCE: Visual ability is a multidimensional construct, with visual acuity, depression, physical ability, and cognition explaining more than one-third of the variance in visual ability as measured by the AI. The significant contributions of the nonvisual factors to visual ability measures and the rehabilitation potential (ie, ceiling) effects they may impose on LVR are important considerations when measuring baseline visual ability and ultimately LVR outcomes in ongoing clinical research.

To evaluate the effectiveness of low-vision rehabilitation in 2 cohorts derived from the Veterans Affairs Low-Vision Intervention Trial.In a prospective study, we observed 44 participants randomly assigned to outpatient low-vision rehabilitation who did not receive additional treatment after the trial ended at 4-month follow-up and 56 participants randomly assigned to the waiting-list control group and thereafter to standard therapy. The outcome measures included visual ability domains (reading, mobility, visual information processing, and visual motor skills) and overall visual ability estimated from difficulty ratings using the 48-item Veterans Affairs Low-Vision Visual Functioning Questionnaire. Mean visual ability scores for the treatment and control groups were compared at baseline, 4 months, and 1 year. A mixed-effects model was used to test treatment effects between groups over time. Differences in visual ability mean scores from baseline to 1 year were compared between the 2 groups. Within-group changes in visual ability were compared from baseline to 1 year, from baseline to 4 months, and from 4 months to 1 year.At baseline, there were no significant differences in mean visual ability scores between groups. From baseline to 4 months, the treatment effects for all visual ability domains and overall visual ability increased to a maximum in the treatment group (P.001), whereas the mean scores (except visual motor skills) decreased in the control group (P.01). From 4 months to 1 year, the differences became smaller. There was a loss of visual ability in reading and visual information processing (but not in visual motor skills, mobility, or overall visual ability) in the treatment group and a gain in all visual ability measures in the control group. Interactions of treatment and follow-up time in the mixed models showed the trend of treatment effects significantly changed over time from baseline to 1 year (P.001) for all visual ability domains and overall visual ability. Both groups demonstrated improvement in visual ability from baseline to 1 year (P.001) (except for mobility in the control group). Overall visual ability (but not other visual ability domains) improved more in the treatment group than in the control group (P= .01).Visual ability improved significantly in both groups from baseline to 1 year. The Low-Vision Intervention Trial treatment effect is robust and well maintained for patients with macular diseases.

OBJECTIVE: To characterize the traits of low vision patients who seek outpatient low vision rehabilitation (LVR) services in the United States. METHODS: In a prospective observational study, we enrolled 764 new low vision patients seeking outpatient LVR services from 28 clinical centers in the United States. Before their initial appointment, multiple questionnaires assessing daily living and vision, physical, psychological, and cognitive health states were administered by telephone. Baseline clinical visual impairment measures and disorder diagnoses were recorded. RESULTS: Patients had a median age of 77 years, were primarily female (66%), and had macular disease (55%), most of which was nonneovascular age-related macular degeneration. More than one-third of the patients (37%) had mild vision impairment with habitual visual acuity (VA) of 20/60 or greater. The VA correlated well with contrast sensitivity (r=−0.52) but poorly with self-reported vision quality. The intake survey revealed self-reported physical health limitations, including decreased endurance (68%) and mobility problems (52%). Many patients reported increased levels of frustration (42%) and depressed mood (22%); memory and cognitive impairment (11%) were less frequently endorsed. Patients relied on others for daily living support (87%), but many (31%) still drove. CONCLUSIONS: Most patients seeking LVR are geriatric and have macular disease with relatively preserved VA. The disparity between VA and subjective quality of vision suggests that LVR referrals are based on symptoms rather than on VA alone. Patients seen for LVR services have significant physical, psychological, and cognitive disorders that can amplify vision disabilities and decrease rehabilitation potential.

Objective: To investigate the effect of coping strategies, depression, physical health, and cognition on National Eye Institute Visual Function Questionnaire scores obtained at baseline in a sample of older patients with age-related macular degeneration (AMD) enrolled in the Improving Function in AMD Trial, a randomized controlled clinical trial that compares the efficacy of problemsolving therapy with that of supportive therapy to improve vision function in patients with AMD. Methods: Baseline evaluation of 241 older outpatients with advanced AMD who were enrolled in a clinical trial testing the efficacy of a behavioral intervention to improve vision function. Vision function was characterized as an interval-scaled, latent variable of visual ability based on the near-vision subscale of the National Eye Institute Vision Function Questionnaire-25 plus Supplement. Results: Visual ability was highly correlated with visual acuity. However, a multivariate model revealed that patient coping strategies and cognitive function contributed to their ability to perform near-vision activities independent of visual acuity. Conclusions: Patients with AMD vary in their coping strategies and cognitive function and in their visual acuity, and that variability determines patients’ self-report of vision function. Understanding patient coping mechanisms and cognition may help increase the precision of vision rating scales and suggest new interventions to improve vision function and quality of life in patients with AMD. Trial Registration: clinicaltrials.gov Identifier: NCT00572039

Vision loss that cannot be corrected medically, surgically, or by refractive means is considered low vision. Low vision often results in impairment of daily activities, loss of independence, increased risk of fractures, excess health care expense, and reduced physical functioning, quality of life, and life expectancy. Vision rehabilitation can enable more independent functioning for individuals with low vision. The Centers for Medicare and Medicaid Services recognizes the importance of rehabilitation for achieving medically necessary goals but has denied Medicare coverage for vision assistive equipment that is necessary to complete these goals, although they provide coverage for assistive equipment to provide compensation for other disabilities. We believe that this is discriminatory and does not comport with congressional intent. The Centers for Medicare and Medicaid Services should provide coverage for vision assistive equipment, allowing beneficiaries with vision loss to benefit fully from Medicare-covered rehabilitation to achieve the cost-effective results of these services.

To evaluate the effectiveness of a low-vision rehabilitation program.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.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.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.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.clinicaltrials.gov Identifier: NCT00223756.

Objective To determine the prevalence and causes of low vision in a large sampleof nursing home residents. Methods Twenty-eight nursing homes on the Eastern Shore of Maryland and Delawarewere enrolled in a clinical trial to assess the impact of vision restoration/rehabilitationon nursing home residents. Visual acuity was measured using both recognitioncharts and preferential looking techniques. An ophthalmologist examined allresidents with visual acuity worse than 20/40 in the better-seeing eye anddetermined the primary cause for decreased vision. Results are reported forthe better-seeing eye. Results Of 2544 eligible residents, 1591 (63%) participated, but 286 residentswere unable to respond to visual acuity testing. Of the remaining 1307 residents,496 (37%) had best-corrected visual acuity worse than 20/40 in the better-seeingeye. Causes were ascribed for 412 subjects. Rates of low vision were similarbetween African American subjects and white subjects (39% and 38%, respectively;age-adjusted P = .18). Cataract was the leading causeof low vision, responsible for 37% of low vision among white subjects and54% of low vision among African American subjects. Macular degeneration wasresponsible for 29% of low vision among white subjects but only 7% among AfricanAmerican subjects. Glaucoma caused low vision in 4% of white subjects and10% of African American subjects. Refractive error was not a frequent causeof low vision in nursing home residents. Conclusions Low vision is highly prevalent among nursing home residents, with 37%having visual acuity worse than 20/40 in the better-seeing eye. Differencesin causes of low vision between African American subjects and white subjectswere noted, with African American subjects more likely to have vision losson the basis of cataract, a readily treated condition. Appropriate interventionsfor nursing home residents, who face significant obstacles in accessing eyecare services, have the potential to improve the quality of life of this at-riskolder population.

In reply In our editorial 1 on vitamin A supplementation as a treatment for RP, 2 we discussed three major areas of concern: (1) the study did not demonstrate significant benefit for any measure of visual function; (2) the significant effect observed with the cone ERG has additional explanations not related to slowed progression of the disease; and (3) the long-term systemic and/or toxic effects of supplemental vitamin A are unknown. The arguments presented by Dr Berson and colleagues in response to our editorial restate points made in their article and provide some new unpublished information, but they do not satisfy our principal concerns. The reaffirmed recommendation of the authors of the clinical trial is that "most adults with the common forms of RP [should] take 15 000 IU/d of vitamin A under the supervision of their ophthalmologist and avoid high-dose supplementation with vitamin E such as the 400 IU/d used

These words conclude the report of a clinical trial published in this issue of theArchivesthat was designed to evaluate the effects of nutritional supplements of vitamins A and E on the natural course of retinitis pigmentosa. This study is a tour de force in experimental design, execution, and statistical analysis. The investigators deserve congratulations on the successful completion of this ambitious, rigorous, and interesting study. See also pp 754 and 761. Retinitis pigmentosa can be a devastating disease for the patient who suffers night blindness, progressive visual field loss, and eventually loss of central vision. There is no cure for retinitis pigmentosa, and patients are in constant search of hope. Therefore, when interpreting the intriguing results of this clinical trial, it is important to use caution and to avoid drawing unwarranted conclusions that could lead to unreasonable expectations by patients. Despite our admiration of the design and execution

In Reply. —In the article 1 discussed by Dr Marmor, we demonstrated, in 235 patients with typical RP and no evidence of visual acuity-limiting cataract or macular edema, that for patients with visual fields smaller than 30°, the prevalence of decreased visual acuity increases with the extent of further visual field loss. Specifically, until the V-4-e visual field reaches 30°, 96% of patients retained 20/40 visual acuity or better. Fewer than one third of patients with visual fields smaller than 10° radius had visual acuities of 20/40 or better and intermediate percentages of patients with 20/40 visual acuity or better were seen at intermediate visual field sizes. In other studies, 2,3 we showed that visual field loss in RP, regardless of subtype, progresses at a very predictable rate, following an exponential decay function. We appreciate Dr Marmor's interest in our work and are grateful for the opportunity to clarify

• Flicker fusion threshold intensities were measured as a function of flicker frequency for patients with Best macular dystrophy having normal or near-normal Snellen visual acuity. These data were found to differ from normal in ways that may be interpreted to be an abnormal elevation of the foveal cone threshold, a loss of cone temporal resolution, or both. The results led to the conclusion that Best macular dystrophy affects the neurosensory retina even when Snellen visual acuity is normal. ( Arch Ophthalmol 95:991-994, 1977)

• Elderly patients with drusen and good visual acuity have a decrease in dark-adapted retinal sensitivity in the central retina. We used the fundus camera stimulator to determine whether this sensitivity loss is caused directly by the presence of drusen. We measured retinal sensitivity over drusen and in drusen-free areas in eight patients with drusen and age-related macular degeneration (AMD). There was no significant difference in sensitivity between drusen and nondrusen areas in each patient. The sensitivity loss seen in patients with drusen thus seems to reflect a more diffuse disease of the retina and retinal pigment epithelium and is not a direct effect of drusen. More marked sensitivity losses are found in even small areas of more advanced AMD changes, suggesting that a large focal loss in retinal sensitivity may be an indicator of developing AMD changes.