Cataract Clinical Trial
Official title:
Clinical Trial of Interventions for Visual Loss in Nursing Home Residents
The purpose of this clinical trial is to determine if interventions within the nursing home to restore vision, or cope with visual loss, in residents with visual impairment result in improvement or less decline in mobility scores, and socialization scores, compared to residents with visual impairment in nursing homes with no such intervention. The investigators hypothesized that nursing home residents with visual loss who receive cataract surgery, or refractive correction, or low vision aids would have have better socialization scores and mobility scores at 6 months and 12 months compared to nursing home residents with visual impairment who are advised to seek services, but have no specific program.
The goal of this project was to quantify the impact of visual acuity impairment on
socialization and physical function of nursing home residents, and to determine the cost
effectiveness of a visual impairment intervention program designed to enhance access to eye
care services. To accomplish these aims, the investigators enrolled a complete sample of
visually impaired persons from 28 nursing homes in the Lower Eastern Shore of Maryland and
Delaware. From the same facilities, the investigators also enrolled a random sample of
non-visually impaired residents, with sample size equal to the sample of visually impaired.
The group of visually impaired residents was randomized (by facility) to an intervention
program or "usual care" group. The intervention program facilitated the utilization of eye
care services of the three main causes of visual impairment: refractive error, cataract, and
low vision associated with age-related eye diseases. All study groups provided data at
baseline, six and twelve months from intervention, and data on eye care utilization,
hospitalizations, use of psychoactive medications and mortality collected every other month
(bi-monthly). Patients had a screening test of visual acuity, using standard letter/symbol
charts, and grating charts. The mental status was tested using the MiniMental State
Examination. Social function, physical function, and mobility were assessed through
questionnaires asked of nursing home staff familiar with the patient, and the questions were
modeled on the Minimum Data Set questions or specially designed for nursing home residents.
The investigators compare the mobility scores, and socialization scores, of nursing home
residents with visual loss randomized to the intervention homes to the scores of nursing home
residents with visual loss randomized to control homes. The investigators use the mobility
and socialization scores of those without visual loss at baseline and follow up to compare
with the trajectory of decline in those with visual loss.
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