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Background: The treatment of idiopathic full-thickness macular holes involves surgery to close the hole. Some surgeons advise patients to adopt a face-down position to increase the likelihood of successful macular hole closure. However, patients often find the face-down positioning arduous. There is a lack of conclusive evidence that face-down positioning improves the outcome. The 'Positioning In Macular hole Surgery' (PIMS) trial will assess whether advice to position face-down after surgery improves the surgical success rate for the closure of large (≥400 μm) macular holes.Methods/design: The PIMS trial is a multicentre, parallel-group, superiority clinical trial with 1:1 randomisation. Patients (n = 192) with macular holes (≥400 μm) will be randomised after surgery to either face-down positioning or face-forward positioning for at least 8 h (which can be either consecutive or nonconsecutive) a day, for 5 days following surgery. Inclusion criteria are: presence of an idiopathic full-thickness macular hole ≥400 μm in diameter, as measured by optical coherence tomography (OCT) scans, on either or both eyes; patients electing to have surgery for a macular hole, with or without simultaneous phacoemulsification and intraocular lens implant; ability and willingness to position face-down or in an inactive face-forward position; a history of visual loss suggesting a macular hole of 12 months' or less duration. The primary outcome is successful macular hole closure at 3 months post surgery. The treatment effect will be reported as an odds ratio with 95% confidence interval, adjusted for size of macular hole and phakic lens status at baseline. Secondary outcome measures at 3 months are: further surgery for macular holes performed or planned (of those with unsuccessful closure); patient-reported experience of positioning; whether patients report they would still have elected to have the operation given what they know at follow-up; best-corrected visual acuity (BCVA) measured using Snellen charts at a standard distance of 6 m; patient-reported health and quality of life assessed using the National Eye Institute Visual Function Questionnaire (VFQ-25).Discussion: The PIMS trial is the first multicentre randomised control trial to investigate the value of face-down positioning following macular hole standardised surgery.Trial Registration: International Standard Randomised Controlled Trials Number registry, ID: ISRCTN12410596. Registered on 11 February 2015. United Kingdom Clinical Research Network, ID: UKCRN17966 . Registered on 26 November 2014. [ABSTRACT FROM AUTHOR]

Background: Idiopathic macular holes are an important cause of blindness. They have an annual incidence of 8 per 100,000 individuals, and prevalence of 0.2 to 3.3 per 1000 individuals with visual impairment. The condition occurs more frequently in adults aged 75 years or older. Macular holes can be repaired by surgery in which the causative tractional forces in the eye are released and a temporary bubble of gas is injected. To promote successful hole closure individuals may be advised to maintain a face-down position for up to 10 days following surgery. The aim of this study is to determine whether advice to position face-down improves the surgical success rate of closure of large (>400 μm) macular holes, and thereby reduces the need for further surgery.Methods/design: This will be a multicentre interventional, comparative randomised controlled clinical trial comparing face-down positioning with face-forward positioning. At the conclusion of standardised surgery across all sites, participants still eligible for inclusion will be allocated randomly 1:1 to 1 of the 2 treatment arms stratified by site, using random permuted blocks of size 4 or 6 in equal proportions. We will recruit 192 participants having surgery for large macular holes (>400 μm); 96 in each of the 2 arms of the study. The primary objective is to determine the impact of face-down positioning on the likelihood of closure of large (≥400 μm) full-thickness macular holes following surgery.Discussion: This will be the first multicentre randomised control trial to investigate the value of face-down positioning following macular hole standardised surgery.Trial Registration: UK CRN: 17966 (date of registration 26 November 2014). [ABSTRACT FROM AUTHOR]