Evaluation of primary outcome, that is, absence of indication for reattaching procedure, based on ITT set (ITT; results for PP set, see online supplementary material)
| E1 20 G vitrectomy with EB (n=100) | C 20 G vitrectomy without EB (n=98) | E1 vs C OR (95% CI) | E2 23/25 G vitrectomy without EB (n=57) | C 20 G vitrectomy without EB (n=61) | E2 vs C OR (95% CI) | |
|---|---|---|---|---|---|---|
| Absence of indication for reattaching procedure | 79 (79.0%) | 72 (73.5%) | 1.32† (0.65 to 2.65) | 50 (87.7%) | 48 (78.7%) | 2.17†‡* (0.80 to 5.89) |
| Additional vitrectomy | 15 (15.0%) | 18 (18.4%) | – | 4 (7.0%) | 7 (11.5%) | – |
| Additional buckle | 1 (1.0%) | 8 (8.2%) | – | 3 (5.3%) | 4 (6.6%) | – |
| Other procedure | 5 (5.0%) | 4 (4.1%) | – | 1 (1.8%) | 2 (3.3%) | – |
| Follow-up <23 weeks§ | 4 (4.0%) | 7 (7.1%) | – | 2 (3.5%) | 5 (8.2%) | – |
*p≤0.05, **p≤0.01, ***p≤0.001.
†Breslow-Day test of homogeneity of ORs over surgeons, p=0.386 (0.071).
‡Asymptotic p value for the test of the common OR against 0.8 (non-inferiority bound): p=0.05.
§And no indication for reattaching procedure during follow-up.
EB, encircling band; G, gauge; ITT, intention-to-treat; PP, per-protocol.