Rohan W Essex1, Zabrina S Kingston2, Margarita Moreno-Betancur3, Bruce Shadbolt4, Alex P Hunyor5, William G Campbell6, Paul P Connell7, Ian L McAllister8. 1. Academic Unit of Ophthalmology, Australian National University, Canberra, Australia. Electronic address: rohan.essex@act.gov.au. 2. Academic Unit of Ophthalmology, Australian National University, Canberra, Australia. 3. Clinical Epidemiology and Biostatistics Unit, Murdoch Childrens Research Institute, Melbourne, Australia; Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Australia. 4. Centre for Advances in Epidemiology and IT, Canberra Hospital, Canberra, Australia. 5. Sydney Eye Hospital, Sydney, Australia. 6. Royal Victorian Eye and Ear Hospital, Melbourne, Australia. 7. Mater Misericordiae University Hospital, Dublin, Ireland. 8. Lions Eye Institute, Centre for Ophthalmology and Visual Science, University of Western Australia, Perth, Australia.
Abstract
PURPOSE: To determine whether sulfur hexafluoride (SF6) gas is noninferior to longer-acting gases in macular hole surgery and whether withholding postoperative face-down positioning (FDP) is noninferior to FDP. DESIGN: Registry-style, prospective, nonrandomized, observational cohort study. PARTICIPANTS: Patients with idiopathic macular holes undergoing primary surgery. METHODS: Surgeons were invited to submit clinical details of all macular hole cases receiving surgery. Baseline demographic and clinical information were collected, as well as details of surgical intervention and postoperative posturing advice. Primary follow-up data were collected 3 months postoperatively. MAIN OUTCOME MEASURES: Macular hole closure at 3 months. A noninferiority approach was used, with a noninferiority margin set at 5% decreased frequency of success. RESULTS: A total of 2456 eyes of 2367 patients were included in the study. Outcomes were available in 94.9% of cases (2330/2456). The rate of macular hole closure was 95.0% (2214/2330). Sulfur hexafluoride gas was found to be noninferior to longer-acting gases (95% confidence interval [CI] for adjusted effect on success, -1.76 to +2.25), and noninferiority was demonstrated regardless of macular hole size. Although withholding FDP was found to be noninferior to FDP for the study population as a whole (95% CI for adjusted effect on success, -4.21 to +0.64), the result was inconclusive in holes >400 μm in diameter (95% CI, -9.31 to +1.04). Lack of internal limiting membrane (ILM) peel, increasing hole size, hole duration ≥9 months, increasing age, and 20-gauge surgery all were associated with lower odds of success. Vitreous attachment to the hole margin was not associated with outcome when corrected for hole size, and combined phacovitrectomy surgery was not observed to affect the odds of success in phakic eyes. CONCLUSIONS: Sulfur hexafluoride gas tamponade was noninferior to longer-acting gases in the surgical management of macular hole. Withholding FDP was noninferior to FDP in holes ≤400 μm in diameter. In holes >400 μm in diameter, noninferiority of withholding FDP could not be concluded. We would advise caution if posturing is withheld in this group on the basis of the results of this study and of others.
PURPOSE: To determine whether sulfur hexafluoride (SF6) gas is noninferior to longer-acting gases in macular hole surgery and whether withholding postoperative face-down positioning (FDP) is noninferior to FDP. DESIGN: Registry-style, prospective, nonrandomized, observational cohort study. PARTICIPANTS: Patients with idiopathic macular holes undergoing primary surgery. METHODS: Surgeons were invited to submit clinical details of all macular hole cases receiving surgery. Baseline demographic and clinical information were collected, as well as details of surgical intervention and postoperative posturing advice. Primary follow-up data were collected 3 months postoperatively. MAIN OUTCOME MEASURES: Macular hole closure at 3 months. A noninferiority approach was used, with a noninferiority margin set at 5% decreased frequency of success. RESULTS: A total of 2456 eyes of 2367 patients were included in the study. Outcomes were available in 94.9% of cases (2330/2456). The rate of macular hole closure was 95.0% (2214/2330). Sulfur hexafluoride gas was found to be noninferior to longer-acting gases (95% confidence interval [CI] for adjusted effect on success, -1.76 to +2.25), and noninferiority was demonstrated regardless of macular hole size. Although withholding FDP was found to be noninferior to FDP for the study population as a whole (95% CI for adjusted effect on success, -4.21 to +0.64), the result was inconclusive in holes >400 μm in diameter (95% CI, -9.31 to +1.04). Lack of internal limiting membrane (ILM) peel, increasing hole size, hole duration ≥9 months, increasing age, and 20-gauge surgery all were associated with lower odds of success. Vitreous attachment to the hole margin was not associated with outcome when corrected for hole size, and combined phacovitrectomy surgery was not observed to affect the odds of success in phakic eyes. CONCLUSIONS:Sulfur hexafluoride gas tamponade was noninferior to longer-acting gases in the surgical management of macular hole. Withholding FDP was noninferior to FDP in holes ≤400 μm in diameter. In holes >400 μm in diameter, noninferiority of withholding FDP could not be concluded. We would advise caution if posturing is withheld in this group on the basis of the results of this study and of others.
Authors: Saruban Pasu; Lauren Bell; Zohra Zenasni; Doris Lanz; Irene A Simmonds; Ann Thompson; David Yorston; D Alistair H Laidlaw; Catey Bunce; Richard Hooper; James W B Bainbridge Journal: JAMA Ophthalmol Date: 2020-07-01 Impact factor: 7.389