OBJECTIVES: To develop a conceptual framework of functional reading independence to support development of a patient-reported outcome (PRO) measure for patients with geographic atrophy (GA) from age-related macular degeneration. METHODS: The conceptual framework was developed based on a literature review, expert opinion and patient input.  Patient input was gathered in a qualitative concept elicitation study with 23 GA patients, where functional reading independence emerged as the most relevant concept. A draft conceptual framework and PRO questionnaire (interviewer-administered) were developed.  Cognitive interviews were then conducted with 17 additional GA patients to assess understanding, completeness and relevance of the concept and items.  Feedback on the questionnaire was also obtained from the patient interviewers, clinical experts and a translation expert. The conceptual framework and questionnaire were subsequently revised. RESULTS: The conceptual framework represents functional reading independence as a unidimensional concept.  Eleven functional reading activities have a direct effect on functional reading independence: 1) reading written print; 2) reading to pay bills or write a check; 3) reading in order to take medicine; 4) reading instructions; 5) reading labels; 6) reading to play games; 7) reading to make or receive a telephone call; 8) reading words or numbers on the screen while watching television; 9) reading when using a computer; 10) reading street signs; and 11) reading signs for directions. The process of performing each functional reading activity may be completely independent, or may involve the use of vision aids, behavior changes to accommodate vision problems, and/or receiving help from another person.      CONCLUSIONS: To our knowledge, this is the first conceptual framework specifically representing functional reading independence from the perspective of patients with GA.  The conceptual framework may evolve once empirical evidence is available.  The questionnaire based on the conceptual framework is currently being tested in a Phase II clinical trial.