Figure 1. Flow of subjects through the “Vision is Precious” study, from eligibility assessment to analysis.
a All exclusions after randomization were due to belated discovery of failure to meet eligibility requirements, specifically these excluded subjects turned out to have had a dilated fundus exam (DFE) within the year preceding randomization, though they did not report this at the time of enrollment.
b One subject died within the 6-month follow-up period for the primary study outcome.
c Subjects who withdrew consent or died were not excluded from analysis; rather, the DFE status as of the time of withdrawal/death was used as their study outcome.