ALIGHT.

Study characteristics
Methods	Phase I/IIa, prospective, parallel group, single‐centre, unmasked, randomised controlled trial One eye selected, non‐exudative age‐related macular degeneration
Participants	Country: United Kingdom Number of people randomised: 60 Age: range 55 to 88 years Sex: 57% female Inclusion criteria: between the ages of 55 and 88 years. Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity of 0.3 logMAR or better (in study eye) early age‐related macular degeneration (in study eye) exudative age‐related macular degeneration (in fellow eye) Exclusion criteria: other ocular pathology significant systemic disease or medication known to affect visual function systemic disease that would compromise participation insufficient English language comprehension cognitive impairment oxygen mask worn at night Equivalence of baseline characteristics
Interventions	Intervention: Noctura 500 eye mask (LED 505 nm 23 scotopic Trolands) worn eight hours every night for 12 months n = 30 Comparator: no treatment n = 30
Outcomes	Primary outcomes: increase in drusen volume beyond test‐retest repeatability limits or a progression to advanced age‐related macular degeneration at 12 months rate of retinal adaptation at 12 months Secondary outcomes: change in drusen volume at 12 months change in time constant of cone dark adaption adverse events compliance the number of ranibizumab re‐treatments (in fellow eye) changes in visual chromatic thresholds visual acuity at 3 months (unpublished) and 12 months change in psychophysical 14 Hz flicker thresholds change in self‐reported outcome measures, including health‐related quality of life (EQ‐5D), visual function (VFQ‐48) and sleep quality questionnaire (PSQI) Contrast sensitivity, near vision, low luminance deficit score, loss of 15 or more EDTRS letters and reading speed were not reported.
Notes	Study name: Alight Dates of recruitment of participants: 04/2014 to 02/2015 Sources of funding: research grant from the College of Optometrists, London, UK Declaration of interest: two authors declared a personal financial interest, indicating they are "inventor/developer designated on a patent, patent application, copyright, or trade secret, whether or not the patent, copyright, etc. is presently licensed or otherwise commercialized, which is the subject matter of your publication or could be in competition with the technology described". Trial investigators were contacted. Trial registration: ISCTRN 82148651
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation sequence using permutated blocks stratified according to AREDs scores 2, 3 and 4.
Allocation concealment (selection bias)	Low risk	Randomisation allocation number provided in envelopes to study investigator.
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants and personnel unmasked to treatment. Clinicians treating fellow eye with neovascular age‐related macular degeneration masked to treatment.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Masking of treating clinicians; however, communication from participants could remove masking. Assessors of primary outcome were masked but not for secondary outcomes.
Incomplete outcome data (attrition bias) All outcomes	High risk	Compliance with wearing treatment mask was 78%. Nine participants withdrew from study due to mask discomfort. Drusen volume data was missing for 24 participants. Final visits for six participants were conducted outside study protocol.
Selective reporting (reporting bias)	Low risk	All outcomes mentioned in the protocol were reported.