¹National Institute of Health Research Biomedical Research Centre (BRC), Moorfields Eye Hospital National Health Service (NHS) Foundation Trust, UCL Institute of Ophthalmology, London, England
²Moorfields Eye Hospital NHS Foundation Trust, London, England
³UCL Institute of Ophthalmology, London, England
⁴Pragmatic Clinical Trial Unit, Queen Mary University of London, London, England
⁵Blizard Institute, Barts and The London School of Medicine and Dentistry, London, England
⁶Gartnavel Royal Hospital, Glasgow, Scotland
⁷St Thomas' Hospital, London, England
⁸Department of Primary Care and Public Health Sciences, King’s College London, London, England

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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

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.

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

Facedown Postoperative Positioning for Large Macular Holes

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