PolyPhotonix has expressed grave concerns over the design, management, analysis and reporting of the Cleopatra study and we believe the publication presents a false and inaccurate summary of the trial and the results.
There are 4 main areas identified within the published Cleopatra paper that are of major importance and are discussed in more detail in the attached paper. However the focus of our concern can be summarised simply as follows:
If a patient does not take a treatment they cannot derive any benefit: Only 4.5% of patients (7/155) enrolled into the trial consistently achieved or exceeded the compliance target.
On a positive note, the Cleopatra study did confirm that the light therapy is safe and also reported another key finding – that half way through the trial the light-masks significantly reduced diffuse diabetic macular oedema. The authors went on to note that this improvement seen at the 12 month mark, was not sustained at 24 months, concluding that the effect was transient and minimal. This was interpreted as a loss of efficacy of the intervention over time, but the analysis did not take into account that, compared with the first year, there was a significant drop in compliance during the second year potentially explaining the transient nature of the effect.
PolyPhotonix has repeatedly requested further post-hoc analysis, where an appropriate statistical model is used to analyse the effect of mask usage patterns.
PolyPhotonix has also submitted a correspondence letter to the Lancet and our full rebuttal document is attached here for your information.