Article
Pilot randomized controlled trial of face-down positioning following macular hole surgery
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Published: | September 21, 2010 |
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Background: The aim of this pilot randomized controlled trial (RCT) was to explore the feasibility of a definitive study to determine the value of face-down positioning following macular hole surgery.
Methods: Thirty subjects underwent complete 20-gauge 3-port-pars-plana vitrectomy with trypan-blue assisted peeling of the inner limiting membrane and injection of 14% perfluoropropane gas. At the completion of surgery subjects were randomly allocated to a 10-days-posturing or a non-posturing group. The primary outcome was anatomical closure assessed 6 weeks following surgery by biomicroscopy and on ocular coherence tomography by two masked consultant retinal surgeons.
Results: We observed an anatomic closure of macular holes in 14 of 15 eyes (93.3%, 95% confidence interval (95% CI) 68–100%) in the posturing group, and in 9 of 15 eyes (60%, 95% CI 32–84%) in the non-posturing group (Fisher's exact test; p=0.08). In a subgroup analysis of outcome according to macular hole size, all holes smaller than 400 µm closed regardless of posturing (100%). In contrast, macular holes larger than 400 µm were closed in 10 of 11 eyes (91%, 95% CI 58–99%) in the posturing group closed and only 4 of 10 (40%, 95% CI 12–74%) eyes in the non-posturing group (p=0.02).
Conclusion: The results of this pilot RCT suggest that postoperative face-down positioning can improve the likelihood of macular hole closure. This benefit appears to be relevant to macular holes of greater than 400 µm in diameter and is not apparent in holes smaller than 400 µm. These results suggest that a definitive RCT to determine the value of posturing in large macular holes specifically would require fewer subjects than a trial including macular holes of all sizes.