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Randomized Controlled Trial
. 2012 Feb;26(2):272-7.
doi: 10.1038/eye.2011.221. Epub 2011 Sep 23.

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

C A K Lange  1 , L Membrey, N Ahmad, L Wickham, R E Maclaren, L Solebo, W Xing, C Bunce, E Ezra, D Charteris, B Aylward, D Yorston, Z Gregor, H Zambarakji, J W Bainbridge
Affiliations
Randomized Controlled Trial

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

C A K Lange et al. Eye (Lond). 2012 Feb.

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 μm closed regardless of posturing (100%). In contrast, holes larger than 400 μm 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=0.02).

Conclusion: Post-operative face-down positioning may improve the likelihood of macular hole closure, particularly for holes larger than 400 μm. These results support the case for a RCT.

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Figures

Figure 1
Figure 1
OCT of a full-thickness macular hole and its measurement using the caliper function. Six radial scans were performed and the largest diameter was recorded for analysis.
Figure 2
Figure 2
Anatomical closure rates after macular hole surgery according to post-operative positioning for (a) all subjects and (b) subgroups according to pre-operative macular hole size.
Figure 3
Figure 3
Change in visual acuity after macular hole surgery according to post-operative positioning for (a) all subjects (b–d) subgroups according to pre-operative macular hole size. (c) Each dot represents the change of VA in one individual. Dots above the green dotted line represent eyes with a significant improvement in visual acuity (≥0.2 logMAR unit). Dots below the red dotted line represent eyes with a significant deterioration in visual acuity (≥0.2 logMAR unit). The vertical black dotted line separates macular holes smaller and larger than 400 μm.
See this image and copyright information in PMC

References

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