Introduction
trauma
Internal limiting membrane (ILM) peeling has become an integral part of the surgical repair of primary idiopathic full-thickness macular holes (iFTMH) and is a common step in a variety of different vitreoretinal procedures, offering several advantages [Etched-tip forceps have been developed to facilitate picking up the ILM atraumatically, by the creation of a laser-ablated micro-pattern on the end of the forceps (Fig. Schematic diagram of etched-tip and standard ILM forceps. The forceps differ only for the tip that in etched-tip model has a specific pattern of 10 × 10 × 5 micron teeth (created on the forceps surface by laser ablation) pointed towards the grasping edge at 30 degreesMultiple parameters need to be considered to evaluate potential forceps-related iatrogenic trauma, with their extent, methodology of assessment and variability ill-defined and no clear parameters to guide sample size calculation. In this regard, feasibility and proof-of-concept studies play a crucial role in investigating this area, representing a key first step in assessing specific study designs and endpoints with the intent to use them in subsequent larger-scale trials [We therefore conducted a proof-of-concept randomised controlled trial (RCT) of patients undergoing conventional ILM peeling for primary iFTMH using standard smooth-tip ILM peeling forceps (Alcon Grieshaber REVOLUTION DSP ILM forceps, Alcon, Fort Worth, TX, US) as compared to etched-tip ILM forceps (Alcon Grieshaber FINESSE SHARKSKIN ILM forceps). We assessed the appropriateness of the trial design including masking and multiple exploratory functional and anatomic outcomes.