A randomised controlled trial evaluating internal limiting membrane peeling forceps in macular hole surgery.

"Declarations Ethical approval and informed consentAll procedures performed in studies involving human participants were in accordance with the ethical standards of the institutions where the study was carried out and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. UK multicentre ethical approval (North of Scotland Research Ethics Committee reference: 19/NS/0124). Informed consent was obtained from all individual participants included in the study. Conflict of interestThe authors declare no competing interests. Conflict of interest The authors declare no competing interests."

"Funding The study was funded as an IIS (IIT#38075469) by Alcon, with payment to Newcastle University. D Steel discloses that his institution has received research grants from Alcon, DORC, Bayer, and Boehringer-Ingleheim, and he has acted as a consultant to Alcon, Novo Nordisk, BVI, Roche, Apellis and Gyroscope for projects unrelated the subject matter in this manuscript. M Habib discloses that his institution has received research grants from Bayer, Alimera and Boehringer-Ingelheim, and he has received honoraria from Novartis, Bayer, Alimera and Roche for projects unrelated the subject matter in this manuscript. R Hillier has acted as a consultant to Roche for projects unrelated the subject matter in this manuscript."

"This masked randomised controlled feasibility trial was registered on the ISRCTN registry (reference 70,557,873), and the protocol is available at https://eprints.ncl.ac.uk/280333. Surgeries were performed by 5 experienced fellowship-trained vitreoretinal surgeons in 3 tertiary ophthalmology centres in the UK: Sunderland Eye Infirmary, Sunderland (DHWS, MH), Royal Victoria Infirmary, Newcastle upon Tyne (RJH, MRK) and Royal Liverpool University Hospital, Liverpool (MTS). All surgeons had independently performed at least 70 FTMH surgeries with ILM peeling prior to the study start. UK multicentre ethical approval was obtained (North of Scotland Research Ethics Committee reference 19/NS/0124). After a comprehensive discussion, all patients signed a written consent form."