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Facedown Positioning Following Surgery for Large Full-Thickness Macular HoleA Multicenter Randomized Clinical Trial

Educational Objective
To determine whether advice to position facedown postoperatively improves the outcome for large macular holes.
1 Credit CME
Key Points

Question  Is the closure of large macular holes improved by advising facedown positioning postsurgery?

Findings  In this randomized clinical trial of 185 participants, macular hole closure in those advised to position facing down was not superior to macular hole closure in those facing forward.

Meaning  The results do not prove that facedown positioning following surgery is more likely to close large macular holes.

Abstract

Importance  The value of facedown positioning following surgery for large full-thickness macular holes is unknown.

Objective  To determine whether advice to position facedown postoperatively improves the outcome for large macular holes.

Design, Setting, and Participants  This randomized, parallel group superiority trial with 1:1 randomization stratified by site with 3 months’ follow-up was conducted at 9 sites across the United Kingdom and included participants with an idiopathic full-thickness macular hole of at least 400 μm minimum linear diameter and a duration of fewer than 12 months. All participants had vitrectomy surgery with peeling of the internal limiting membrane and injection of perfluoropropane (14%) gas, with or without simultaneous surgery for cataract.

Interventions  Following surgery, participants were randomly advised to position either facedown or face forward for 8 hours daily for 5 days.

Main Outcomes and Measures  The primary outcome was closure of the macular hole determined 3 months following surgery by masked optical coherence tomography evaluation. Secondary outcome measures at 3 months were visual acuity, participant-reported experience of positioning, and quality of life measured by the National Eye Institute Visual Function Questionnaire 25.

Results  A total of 185 participants (45 men [24.3%]; 156 white [84.3%]; 9 black [4.9%]; 10 Asian [5.4%]; median age, 69 years [interquartile range, 64-73 years]) were randomized. Macular hole closure was observed in 90 (85.6%) who were advised to position face forward and 88 (95.5%) advised to position facedown (adjusted odds ratio, 3.15; 95% CI, 0.87-11.41; P = .08). The mean (SD) improvement in best-corrected visual acuity at 3 months was 0.34 (0.69) logMAR (equivalent to 1 Snellen line) in the face-forward group and 0.57 (0.42) logMAR (equivalent to 3 Snellen lines) in the facedown group (adjusted mean difference, 0.22 [95 % CI, 0.05-0.38]; equivalent to 2 Snellen lines); 95% CI, 0.05-0.38; P = .01). The median National Eye Institute Visual Function Questionnaire 25 score was 89 (interquartile range, 76-94) in the facedown group and 87 (interquartile range, 73-93) in the face-forward group (mean [SD] change on a logistic scale, 0.08 [0.26] face forward and 0.11 [0.25] facedown; adjusted mean [SD] difference on a logistic scale, 0.02; 95% CI, −0.03 to 0.07; P = .41).

Conclusions and Relevance  The results do not prove that facedown positioning following surgery is more likely to close large macular holes compared with facing forward but do support the possibility that visual acuity outcomes may be superior.

Trial Registration  Isrctn.org Identifier: 12410596

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Article Information

Accepted for Publication: March 2, 2020.

Corresponding Author: James W. B. Bainbridge, PhD, UCL Institute of Ophthalmology, 11-43 Bath St, London EC1V 9EL, England (j.bainbridge@ucl.ac.uk).

Published Online: May 7, 2020. doi:10.1001/jamaophthalmol.2020.0987

Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2020 Pasu S et al. JAMA Ophthalmology.

Author Contributions: Dr Hooper and Ms Zenasni had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Pasu, Thomson, Yorston, Laidlaw, Bunce, Hooper, Bainbridge.

Acquisition, analysis, or interpretation of data: Pasu, Bell, Zenasni, Lanz, Simmonds, Yorston, Bunce, Hooper, Bainbridge.

Drafting of the manuscript: Pasu, Bell, Zenasni, Bunce, Bainbridge.

Critical revision of the manuscript for important intellectual content: Pasu, Zenasni, Lanz, Simmonds, Thomson, Yorston, Laidlaw, Bunce, Hooper, Bainbridge.

Statistical analysis: Bell, Zenasni, Bunce, Hooper.

Obtained funding: Pasu, Bunce, Bainbridge.

Administrative, technical, or material support: Pasu, Lanz, Simmonds, Thomson.

Supervision: Thomson, Yorston, Bainbridge.

Other - Trial Management: Thomson.

Conflict of Interest Disclosures: Dr Hooper reported grants from the UK National Institute for Health Research (NIHR) during the conduct of the study. No other disclosures were reported.

Funding/Support: This study was funded by the NIHR Research for Patient Benefit grant PB-PG-0213-30085.

Role of the Funder/Sponsor: The funder had no role in study design, data collection, data analysis, data interpretation, or writing of the report.

Positioning In Macular Hole Surgery (PIMS) Study Group: Trial steering committee: Noemi Lois, Belfast Health and Social Care Trust; Simon Skene, University College London; Roy Smith; patient advisory panel: Roy Smith, Ann Hadley, Carol Martin, Elizabeth Heap; masked assessors: Edward Herbert, MA, Musgrove Park Hospital Taunton; Ed Hughes, BSc, MD, Sussex Eye Hospital; study group: David Charteris, MD, Moorfields Eye Hospital National Health Service (NHS) Trust,; Timothy F. Cochrane, Maidstone and Tunbridge Wells NHS Trust; Felipe Dhawahir-Scala, LMS, Manchester Royal Eye Hospital; Eric Ezra, MD, Moorfields Eye Hospital NHS Trust; Maged Habib, MSc, MD, Sunderland Eye Infirmary; Assad Jalil, Manchester Royal Eye Hospital; Johannes Kelller, Bristol Eye Hospital; Mo Majid, PhD, Bristol Eye Hospital; Luke Membrey, Maidstone and Tunbridge Wells NHS Trust; Mahi Muqit, PhD, Moorfields Eye Hospital NHS Trust; Niall Patton, MD, Manchester Royal Eye Hospital; M. Teresa Sandinha, MD, Royal Liverpool University Hospital; Jonathan Smith, Sunderland Eye Infirmary; David Steel, PhD, Sunderland Eye Infirmary; Paul Sullivan, MD, Moorfields Eye Hospital NHS Trust; Louisa Wickham, MD, Moorfields Eye Hospital NHS Trust.

Data Sharing Statement: See Supplement 4.

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