(Pilot) Performance of EArly Retinal Laser (PEARL) (360G-Wellcome-202974_Z_16_Z)

The prevalence of diabetes in China has risen tenfold since 1981. Virtually all of China's 114 million diabetic persons willdevelop diabetic retinopathy (DR) eventually, and timely laser treatment reduces blindness by 50%. Still, only 10% of ruralpersons with DR in China receive treatment, partly because current care requires them to be followed for several yearsbefore reaching treatment criteria, during which many are lost.Our recent review suggests that earlier treatment, which could reduce the compliance burden, may be clinically efficaciousand cost effective, but current evidence is insufficient. Our pilot work confirms rural patients find long-term adherencedifficult, and earlier treatment is acceptable to patients and providers. We now propose a pilot randomised trial to determinewhether earlier laser treatment improves outcomes and compliance among those with diabetic retinopathy in China.Patients will be recruited from one of China's largest hospitals, and treated after training provided by the top-ranked eyehospital in the country. Participants with severe non-proliferative diabetic retinopathy (NPDR) in both eyes will berandomized to receive: pan-retinal photocoagulation (PRP) applied immediately in one eye at random and PRP in thefellow eye only when proliferative diabetic retinopathy (PDR) develops (Early Intervention-n=100) or PRP at the PDR stagein both eyes (Standard Care group-n=100). The latter group is needed in particular, to test whether early laser treatmenthas an effect on adherence.At 1 year follow-up, the primary outcome will be progression to PDR, with secondary outcomes including loss of vision,complications, quality of life and cost effectiveness. In addition to informing a full trial, this study will address questions of importance to diabetic eye care in low resourcesettings by validating physician clinical diagnosis of DR compared to more expensive technologies and testing a simplifieddefinition of severe NPDR.