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

Area of Science:

• Ophthalmology
• Surgical Innovation
• Clinical Trial Methodology

Background:

• Glaucoma surgery is common, but reporting of surgical complications lacks standardization.
• Existing glaucoma surgical trials often fail to adequately report harm and complication severity.
• This deficiency hinders comparative analysis and patient safety assessments.

Purpose of the Study:

• To critically evaluate harm reporting standards in glaucoma surgical trials.
• To develop a novel classification system for grading the severity of surgical complications in glaucoma.

Main Methods:

• A systematic review of glaucoma surgical trials (2010-2017) assessed harm reporting against the CONSORT checklist.
• A Delphi consensus method involved 43 international glaucoma experts to grade complication severity (1-10 scale).
• Consensus grading was specifically applied to complications from trabeculectomy and aqueous shunt procedures.

Main Results:

• Forty-seven trials were reviewed; key missing harm data included validated severity instruments and subgroup analyses.
• The Delphi method achieved expert consensus on 99% of complications.
• Severe complications included endophthalmitis and permanent vision loss (grade 10); mild included transient vision loss and asymptomatic findings (grade 2).

Conclusions:

• Glaucoma surgical trials frequently report complications but seldom their severity, indicating poor harm reporting quality.
• A new consensus-derived classification system is proposed for consistent severity assessment of surgical complications.
• Implementing this system can improve the quality of harm reporting in future glaucoma surgical research.