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Yvonne M Buys, David J Mathew, Bryon R McKay, Alfred Basilious, Avner Belkin, Graham E Trope; Adherence to World Glaucoma Association Guidelines for Surgical Trials in the Era of Microinvasive Glaucoma Surgeries. Invest. Ophthalmol. Vis. Sci. 2019;60(9):3919.
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© ARVO (1962-2015); The Authors (2016-present)
To determine how well microinvasive glaucoma surgical trials (MIGS) conform to the World Glaucoma Association (WGA) guidelines.
Using a predefined search strategy, the following databases were searched for comparative trials involving MIGS in the English peer-reviewed literature from January 1, 2000 to June 21, 2018: Medline, EMBASE, BIOSIS, Cochrane and Web of Science. From the WGA guidelines, 53 outcomes were selected for evaluation: methodology (31), definition of success (7), ethics (10), postoperative complications (1), economic evaluation (1) and statistical reporting (3). Each article was assessed by two reviewers; differences were resolved by consensus.
Twenty-eight eligible publications were identified; three were longer-term follow-ups from a previous publication, leaving 25 studies, 10 randomized controlled trials (RCT) and 15 non-randomized comparative trials (non-RCT). The mean follow-up of the studies was 19.9±11.6 months (range, 6-48). The mean number of outcomes adhering to the WGA guidelines out of the 53 evaluated was 24.2±6.1 (45.6% compliance): 28.0±6.2 (52.8%) and 21.6±4.7 (40.8%) for RCT and non-RCT, respectively (p=0.01). Mean percent compliance for each subsection were: methodology 48.8%; definition of success 21.1%; ethics 55.6%; postoperative complications 88%; economic evaluation 0%; and statistical reporting 37.3%. In 16 studies (64%), at least one author reported an association with the industry. 32% of studies reported an author being a shareholder. 24% of studies had an industry employee as an author. The primary IOP endpoint was defined as both an upper limit and percentage reduction in only 4 (16%) studies (1 RCT, 3 non-RCT). An IOP-based survival curve was provided in 7 (28%) studies (none of the RCTs). Two studies (8%) had an IOP scatterplot. Twelve studies (48%) reported 95% confidence intervals. The use of Goldmann applanation tonometry for intraocular pressure (IOP) measurement was mentioned in 18 (72%) studies. Only 4 (16%) studies used the mean of three diurnal IOP readings as the baseline IOP.
Published comparative MIGS trials show low adherence (45.6%) to the WGA guidelines. Development of standardized methodology and outcomes could enhance interpretation and transparency of study results and facilitate comparisons between trials. Authors and journals should be encouraged to follow the WGA guidelines.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.
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