OBJECTIVES: To investigate whether a 1-line (5 letters) average change in best corrected visual acuity (BCVA) is associated with changes in health-related quality of life (HRQoL) in patients with diabetic macular edema (DME). METHODS: Data from a 12-month randomized trial of dexamethasone intravitreal implant plus laser or laser alone for DME were analyzed. HRQoL was assessed by the National Eye Institute 25-Item Visual Function Questionnaire (VFQ-25). Patients were categorized into groups based on time-weighted average BCVA change from baseline: worsened (ΔBCVA ≤-5), no change (-5