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.
Conflict of interest statement
Positioning In Macular hole Surgery (PIMS): statistical analysis plan for a randomised controlled trial.Trials. 2017 Jun 13;18(1):274. doi: 10.1186/s13063-017-2020-6. Trials. 2017. PMID: 28610601 Free PMC article. Clinical Trial.
A randomized controlled trial of alleviated positioning after small macular hole surgery.Ophthalmology. 2011 Jan;118(1):150-5. doi: 10.1016/j.ophtha.2010.04.040. Epub 2010 Oct 29. Ophthalmology. 2011. PMID: 21035869 Clinical Trial.
Vitrectomy with internal limiting membrane (ILM) peeling versus vitrectomy with no peeling for idiopathic full-thickness macular hole (FTMH).Cochrane Database Syst Rev. 2013 Jun 5;(6):CD009306. doi: 10.1002/14651858.CD009306.pub2. Cochrane Database Syst Rev. 2013. PMID: 23740611 Review.
Spectral domain optical coherence tomography-guided versus 1-week facedown-posturing after macular hole surgery.Can J Ophthalmol. 2017 Feb;52(1):9-12. doi: 10.1016/j.jcjo.2016.07.009. Epub 2016 Nov 16. Can J Ophthalmol. 2017. PMID: 28237156
Vitrectomy for idiopathic macular hole.Cochrane Database Syst Rev. 2015 May 12;2015(5):CD009080. doi: 10.1002/14651858.CD009080.pub2. Cochrane Database Syst Rev. 2015. PMID: 25965055 Free PMC article. Review.