A multicentre phase III randomised controlled single-masked clinical trial evaluating the cl inical e fficacy and safety o f light-masks at p reventing dark-a daptation in the tr eatment of ea rly diabetic macular oedema (CLEOPATRA): study protocol for a randomised controlled trial

Table 1 CLEOPATRA - summary of study assessments

	Baseline	Week 1	Month 4	Month 8	Month 12	Month 16	Month 20	Month 24 End of trial
Study Week/Month	Visit 1	Visit 2	Visit 3	Visit 4	Visit 5	Visit 6	Visit 7	Visit 8	Withdrawal
Registration/Demographics	x
Informed consent	x
Eligibility form	x
Randomisation form	x
Medical history	x
Concomitant medications	x		x	x	x	x	x	x	x
HbA1c	x				x			x	x
BP	x				x			x	x
Pittsburgh Sleep Quality Index & Epworth Sleepiness Scale	x	x			x			x	x
BCVA (refraction at baseline, 12 and 24 months)	x		x	x	x	x	x	x	x
BCVA (repeated at baseline)^a	x
OCT - macular thickness protocol^b	x		x	x	x	x	x	x	x
Colour photographs - 3-field	x				x			x	x
Mask compliance form		x	x	x	x	x	x	x	x
Adverse events form		x	x	x	x	x	x	x	x
Withdrawal form									x
Additional tests for mechanistic evaluation (n = 30)
Microperimetry dark-adapted	x				x
mfERG	x				x
Retinal oximetry	x				x

BCVA: best corrected visual acuity; OCT: optical Coherence Tomography; mfERG: multifocal electroretinogram; BP: blood pressure. Note: where an ‘x’ is contained within a field this denotes that the associated data will be collected at the identified time point. ^adenotes that visual acuity with new refraction should be repeated at baseline. ^bdenotes that OCT scans should be repeated at month 12 and 24 to test for inter-test variability. The average of the two central subfield thicknesses on OCT will be used for the analysis.

ISSN: 1745-6215