Systematic review of the method and quality of reporting of complications from studies evaluating innovative glaucoma...

The objective of this systematic review is to identify how reporting of micro-invasive glaucoma surgery (MIGS) procedure complications are reported in randomised controlled trials (RCTs) and the quality of this reporting compared to the CONSORT extension for harms. RCTs evaluating MIGS procedures were identified from a database of systematic reviews and from recent literature. Trials were evaluated in comparison to the CONSORT extension for harms to quantify the quality of harms reporting. Simple descriptive statistics were calculated for the CONSORT checklist. 21 trials were identified as eligible for inclusion, 14 were evaluating iStent, one Trabectome, three Hydrus, one Cypass, one Preseflo MicroShunt and one Excimer laser trabeculotomy. The average number of CONSORT for Harms checklist items fulfilled by the studies was 10 out of 16. No studies used a validated instrument to report severity of harms and only 4 had a list or definition of adverse events. An analysis of harm was conducted by 19 of 21 studies (90%). Appropriate metrics were used for reporting rates of adverse events in 19 of 21 studies but in only 4 studies was there an attempt to give these adverse events a grade of seriousness. In conclusion, most studies evaluating MIGS procedures do make an effort to acknowledge harms data, however this is not done uniformly well or in the same manner. A validated instrument to report severity and a standard list of complications for MIGS surgery would go a long way to helping this.