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 protocolb | 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.