Pilot randomised controlled trial of face-down positioning following macular hole surgery

Abstract

Objective This was a pilot randomised controlled trial (RCT) to investigate the effect of post-operative face-down positioning on the outcome of macular hole surgery and to inform the design of a larger definitive study. Methods In all, 30 phakic eyes of 30 subjects with idiopathic full-thickness macular holes underwent vitrectomy with dye-assisted peeling of the ILM and 14% perfluoropropane gas. Subjects were randomly allocated to posture face down for 10 days (posturing group) or to avoid a face-up position only (non-posturing group). The primary outcome was anatomical hole closure. Results Macular holes closed in 14 of 15 eyes (93.3%; 95% confidence interval (CI) 68-100%) in the posturing group and in 9 of 15 (60%; 95% CI 32-84%) in the non-posturing group. In a subgroup analysis of outcome according to macular hole size, all holes smaller than 400 lm closed regardless of posturing (100%). In contrast, holes larger than 400 lm closed in 10 of 11 eyes (91%; 95% CI 58-99%) in the posturing group and in only 4 of 10 eyes (40%; 95% CI 12-74%) in the non-posturing group (Fisher's exact test P ¼ 0.02). Conclusion Post-operative face-down positioning may improve the likelihood of macular hole closure, particularly for holes larger than 400 lm. These results support the case for a RCT.

The Case Mix of Patients Presenting with Full-Thickness Macular Holes and Progression before Surgery: Implications for Optimum Management

“…The need for posturing is debated with many studies showing successful non-posturing surgery in holes <400 μm and often with the use of short-acting gases [5,15,16,17,18]. Large holes are still usually treated with longer-acting gases and posturing [5,6,7,19,20] although the requirement for posturing is debated and a further study is needed [21]. For about 3/4 (72%) of our patients' vitrectomy surgery would currently be the only available treatment option but in only approximately a 1/3 of the cases (28.5%), would vitrectomy, ILM peeling, long-acting gas and post-operative face-down posturing be recommended by the majority of surgeons.…”

“…Inner limiting membrane (ILM) peeling has been shown to be beneficial in terms of closure for all macular holes but because of potential side effects some surgeons do not peel in small and medium-sized holes [3,4]. Two randomized controlled trials have shown that post-operative face-down posturing improves hole closure rate in holes >400 μm in size but many surgeons practice non-posturing surgery in those <400 μm [5,6,7]. The mix of macular hole cases thus presenting to surgeons is important in predicting which options will be selected and which resources needed.…”

Pilot randomised controlled trial of face-down posturing following phacovitrectomy for macular hole

“…In the other, patients had vitrectomy followed by cataract surgery. 21 The purpose of these pilot studies was to estimate the number of patients required to identify a difference in outcome in a definitive trial.…”

Dynamics of Macular Hole Closure in Gas-Filled Eyes within 24 h of Surgery Observed with Swept Source Optical Coherence Tomography

“…Even in an upright position, gas tamponading exerts an effect on MHs as long as gas covers the lesion. However, some of these series did not attain the success rate achieved with standard treatment, especially when the minimum diameter of the MH was greater than 400 µm [3,5,6]. A recent meta-analysis reported slightly higher MH closure rates with 5-10 days of face-down posturing as compared with posturing for 24 h or less, but this difference was not statistically significant [7].…”

“…A recent meta-analysis reported slightly higher MH closure rates with 5-10 days of face-down posturing as compared with posturing for 24 h or less, but this difference was not statistically significant [7]. Yet other reports have demonstrated success rates of 100% for small MHs (<400 µm) either with or without postoperative face-down posturing [6,8,9]. However, perhaps the safest treatment approach is confirmation of MH closure in gas-filled eyes within 24 h before allowing patients to discontinue face-down posturing on day 1.…”