Short summary

In this 6-month 1:1 randomized, prospective study we want to investigate whether individualized retinal laser treatment compared with standard laser treatment has the same efficacy but less side effects in treating proliferative diabetic retinopathy (PDR). Furthermore, we want to study whether optical coherent tomography angiography (OCT-A) can be used as an objective marker for disease activity in PDR. We also want to obtain a better understanding of patient-reported barriers to standard laser treatment and whether these can be addressed with personalized retinal laser treatment.

Rationale

Diabetic eye disease is the most frequent complication among the 320,000 Danes with diabetes. The formation of new vessels (PDR) in the inner part of the eye (retina) is a feared complication and a leading cause of blindness, since these vessels are fragile and often

cause bleeding within the eye. Peripheral retinal laser treatment (PRP) halves the risk of blindness, but often comes with a high prize. The peripheral part of the retina is responsible for the visual field and the night vision, and PRP limits these abilities (i.e. loss of driving license). The technique of PRP has principally been the same for the past 40 years with standard treatment given for all patients. With this one size fits all approach, a substantial number of patients will either be treated too much or too little. Too little treatment is inefficient, and disease progression may occur. On the other hand, excessive treatment may cause side effects like loss of visual fields and decreased night vision. Therefore, it is important to test if treatment can be applied on an individual basis to give a better balance with high efficacy and minimal side effects.

Description of the cohort

58 consecutively recruited patients with newly diagnosed proliferative diabetic retinopathy (PDR) at the Department of Ophthalmology, Odense University Hospital, included between 1 June 2017 and 31 Maj 2018.

Data and biological material

Retinal digital images, fluorescein angiography, OCT-A (BL, M3, M6).

Test of visual fields, dark adaptation and quality of life (BL, M6).

Semi-structured interview will be performed with five patients who have received PRP in one eye and individualized laser treatment in the other eye. This will address treatment experience, potential barriers to treatment, etc.

Collaborating researchers and departments

Department of Ophthalmology, Odense University Hospital and University of Southern Denmark

• PhD student Anna Stage Vergmann
• Professor Jakob Grauslund
• Thomas Lee Torp

Belfast, UK

• Professor Tunde Peto

Singapore

• Professor Tien Wong

Yamagata, Japan

• Professor Ryo Kawasaki