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Ethical Concerns in Potentially Harmful Procedures in Ophthalmic Clinical Studies

Importance In clinical research, ethical principles and practice must be transparent, clearly defined and monitored. We believe that potentially harmful and non-beneficial interventions in diagnostic and placebo-controlled ophthalmology research should be avoided. We advise on alternative study designs and make recommendations for both researchers and research ethics committees. Observations We discuss the use of potentially harmful diagnostic interventions in clinical investigations, e.g., lumbar puncture in glaucoma patients, and sham saline solution injections in eyes with vitreomacular adhesion. In placebo-controlled research studies, patients in the control group commonly did not receive the standard of care for the condition under consideration, e.g., antiglaucoma therapy in a glaucoma study, anti-vascular endothelial growth factor agents in neovascular age-related macular degeneration or central retinal vein occlusion. Testing new methods and treatments against no intervention control, especially invasive placebo, rather than the usual standard of care, where one exists should not be recommended. Conclusions/Relevance Invasive and potentially harmful procedures in ophthalmology can be replaced by alternative non-invasive techniques or by an analysis of patients undergoing the procedure of interest for other purposes.