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A systematic review using the CONSORT Extension for Harms framework has presented the reporting of complications in retinal detachment surgical trials. 

An international consortium of researchers, led in the UK, with Japan, USA, India and Switzerland, have reported results of a systematic review on complications in retinal detachment surgery.  The review suggested that severity of complications of RRD surgery has been “infrequently quantified in randomized clinical trials and potentially represents an important area of improvement in future RRD surgical trials”.  The study showed that the frequency of complications was commonly reported – 29 studies – while the authors showed 10 studies with complication severity.  In summary, results indicated that key areas may require an improvement in the reporting of complications of RRD surgical trials.


Rhegmatogenous retinal detachment (RRD), arising from the separation of the neurosensory retina to the retinal pigment epithelium (RPE), due to a retinal break, leads to accumulation of fluid beneath the retina.  Surgical techniques can repair the RRD by means of pars plana vitrectomy, scleral buckling, or pneumatic retinopexy.   A systematic review of randomized clinical trials (RCTs) on RRD surgery, over a period of 13 years, found fifty studies in the analyses. According to the researchers, the median number of checklist items collated were 8, of a possible total of 18 (across a range, 0-15 items). Frequently reported items were discussions balanced with regard to efficacy and adverse events (42 studies [84%]) and inclusions of harm-associated timing of data collection (41 studies [82%]). The least frequently reported items were distinctions between expected and unexpected adverse events (1 study [2%]) and mentions of the use of a validated instrument to report adverse event severity (4 studies [8%]).


One of the frameworks across these studies has shown that the basis of formally grading of complications by severity is a significant challenging process, and, according to the reviewers, there are “few validated grading scales currently exist in the field of vitreoretinal surgery”. Although there are a variety of systems to be viewed, a number of researchers may not be able to grade the relative severity of one complication against another – for example, comparing a severity of a cataract vs. an iatrogenic retinal tear. Following the systematic review, the authors concluded that, “surgery for RRD is therefore in an excellent position to benefit from scrutiny and development of rigorous harms reporting practices to help refine the vitreoretinal surgeon’s approach to the repair of RRD. Improvement in the reporting of harms in RRD surgical trials should be pursued in line with the CONSORT Extension for Harms recommendations”.