TY - JOUR
T1 - The Effect of Postoperative Face-Down Positioning and of Long- versus Short-Acting Gas in Macular Hole Surgery: Results of a Registry-Based Study
AU - Essex, R.W.
AU - Kingston, Z.S.
AU - Moreno-Betancur, M.
AU - Shadbolt, B.
AU - Hunyor, A.P.
AU - Campbell, W.G.
AU - Connell, P.P.
AU - Mcallister, Ian
PY - 2016/5/1
Y1 - 2016/5/1
N2 - © 2016 American Academy of Ophthalmology. 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.
AB - © 2016 American Academy of Ophthalmology. 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.
U2 - 10.1016/j.ophtha.2015.12.039
DO - 10.1016/j.ophtha.2015.12.039
M3 - Article
C2 - 26920098
SN - 0161-6420
VL - 123
SP - 1129
EP - 1136
JO - Ophthalmology
JF - Ophthalmology
IS - 5
ER -