Diabetic macular oedema and diode subthreshold micropulse laser (DIAMONDS): study protocol for a randomised controlled trial

Table 1 Schedule of assessments and procedures

	Baseline^b	Post randomisation (months)
	Baseline^b	4^b	8^b	12^b	16^b	20^b	24^b
Informed consent	✓
Medical history	✓	✓	✓	✓	✓	✓	✓
HbA1c^a	✓
BCVA in study eye and fellow eye	✓	✓	✓	✓	✓	✓	✓
Binocular distance vision	✓			✓			✓
Humphrey 10–2 visual field in study eye	✓			✓			✓
Esterman binocular visual field	✓			✓			✓
SD-OCT	✓	✓	✓	✓	✓	✓	✓
NEI VFQ-25	✓			✓			✓
EQ-5D-5L	✓			✓			✓
VisQol	✓			✓			✓
Randomisation	✓
Subthreshold micropulse laser/ standard threshold laser	✓	^$	^$	^$	^$	^$	^$
Adverse events	✓	✓	✓	✓	✓	✓	✓

BCVA best corrected visual acuity, SD-OCT spectral domain optical coherence tomography, NEI-VFQ-25 National Eye Institute Visual Functioning Questionnaire-25, EQ-5D-5 L European Quality of Life-5 Dimensions, $ retreatment is possible at follow-up visits if needed
^aIf glycosylated haemoglobin type A1C (HbA1c) has been tested in the past 3 months and its value is available, it can be recorded in the case report form. If no previous HBA1c test (within the previous 3 months from baseline), a blood sample should be drawn to measure it. HbA1c is obtained as a measure of glycaemic control
^bVisits may take place within ± 14 days of the due date

ISSN: 1745-6215