Reporting Harm in Glaucoma Surgical Trials: Systematic Review and a Consensus Derived New Classification System

Samantha Sii, Keith Barton, Louis R. Pasquale, Tetsuda Yamamoto, Anthony J. King, Augusto Azuara-Blanco

Research output: Contribution to journalArticlepeer-review

10 Citations (Scopus)
258 Downloads (Pure)


Purpose: To evaluate the standards of harm reporting for glaucoma surgical trials and to develop a classification system for reporting surgical complication severity.Design: Systematic Review and Delphi consensus method.Methods: Systematic review of glaucoma surgical trials published from January 2010 until July 2017 with a quality assessment against the CONSORT checklist for harm. A Delphi method was employed to generate consensus (interquartile range ≤ 2) among international glaucoma experts (n=43) on severity of glaucoma surgical complications and, specifically for trabeculectomy and aqueous shunt complications, from 1 (no clinical significance) to 10 (most severe complication).Results: 47 studies were eligible. The items of the CONSORT checklist for harm that were most frequently missing were: use of a validated instrument to report severity (0%), withdrawals due to harm, and subgroup analyses reported in 3 publications (6.4%). Most glaucoma experts participating in the Delphi process (80%) completed the second round, and consensus was achieved for all but one complication. The least severe complications (graded 2) were: ‘transient loss of vision’, ‘early low intraocular pressure’, ‘choroidal detachment anterior to equator’, ‘small layered hyphema < 1 mm’, and ‘increased lens opacity not clinically significant’. The most severe complications (graded 10) were ‘endophthalmitis’ and ‘permanent severe loss of vision (hand movements or worse)’.Conclusions: Glaucoma surgical RCTs report frequency of complications but their severity is rarely reported. The quality of harm reporting is poor. We propose the use of a newly developed system of classification for assessing the severity of surgical complications based on consensus.
Original languageEnglish
Pages (from-to)153-162
Number of pages10
JournalAmerican Journal of Ophthalmology
Early online date24 Jul 2018
Publication statusEarly online date - 24 Jul 2018


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