Table 2.

Trial intervention diagram

Procedures	Screening	Baseline	Randomisation	Follow-up schedule						Study completion	Premature discontinuation
				6 months*	12 months*	18 months*	24 months*	30 months*	36 months*
Signed consent form	X
Visual acuity (logMar)		X		X	X	X	X	X	X
Visit questionnaire		X
QoL questionaire† (HUI3 and EQ5D)		X		X	X	X	X	X	X
Assessment of eligibility criteria	X	X	X
Randomisation			X
Digital imaging		X		X	X	X	X	X	X
Acceptability questionnaire									X

*PWD are randomised to two arms. In one arm, individuals attend at 12-month intervals. In the other arm, individuals attend at 6, 12 or 24 monthly intervals.

†The EQ-5D-5L and HUI3 data will be collected on around 700 eligible PWD and repeated at each visit for those individual PWD. Data will be stratified to balance equal numbers of PWD in each arm and representation from all screening sites.

HUI3, Health Utilities Index Mark 3; QoL, quality of life; PWD, people with diabetes.