Cataract extraction and intraocular lens implantation (CE/IOL) is the most common surgery performed on Medicare beneficiaries accounting for $3.4 billion in the 1991 budget(2). Previous research indicates that approximately 25 percent of patients who undergo CE/IOL have less than a 30 percent chance of reporting improvements in vision function after surgery. These investigators have developed a clinical decision tool that identifies persons who are unlikely to report improvements after CE/IOL (3). However, without a clinical trial, it is impossible to know if patients with low predicted probability for improvement after CE/IOL would have had even greater declines in functioning without surgery. The proposed Intervention Study (IS) will answer this important clinical question. To determine visual outcome for persons with low probability for improvements after CE/IOL when managed with non-surgical care, these investigators propose a randomized clinical trial. The goal of this IS is to determine the functional and financial outcomes of surgical versus non-surgical management of age-associated cataracts among patients with low predicted probability of improvement in visual functioning after surgery. The study will also identify the psychophysical mechanisms related to change in visual function that underlie the intervention's effect on functional status. In preparation for the IS, an 18 month IDS is also proposed. The IDS will examine design characteristics that may influence ophthalmologists' and patients' willingness to participate in the IS. The IDS will test the integration of the IS into routine care, and will determine consent rates for randomization. This information will influence the number of ophthalmology practices needed to complete the IS. Most importantly, the IDS will provide a better understanding of the barriers to participation in among non-consenters from diverse cultural backgrounds. This information will be used to refine the IS protocol. Finally the IDS will assess the reliability and validity of two accepted methods of utility assessment to identify the preferred method for use in the IS. In conclusion, the IS addresses a critical step in the evaluation of a clinical, evidence-based approach for identifying patients who are likely to benefit from a common surgical procedure. Findings from the study should improve selections of persons for CE/IOL.
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