Outcome data
| Control group | Adjunct group | Difference (adjunct vs control) | OR (adjunct vs control) | P value | |
| Primary outcome | |||||
| >10 ETDRS Letter BCVA gain at 6 months | 56/129 (43.4%) | 61/130 (46.9%) | 3.5% (−8.6% to 15.6%) | 1.03 (0.61 to 1.75) | 0.908 |
| Principle secondary outcome | |||||
| Change in ETDRS BCVA at 6 months: mean (SD) | 18.9 (29.2) | 19.4 (30.8) | −2.65 (−9.22 to 3.92) | ||
| Median (IQR) | 5 (0 to 41) | 5 (0 to 43) | Adjusted* mean difference | 0.430 | |
| Secondary outcomes | |||||
| Retinal PVR re-detachment | 35/124 (28.2%) | 42/124 (33.9%) | 5.6% (−5.9% to 17.1%) | 1.31 (0.76 to 2.27) | 0.327 |
| Stable complete retinal reattachment† | 79/123 (64.2%) | 65/126 (51.6%) | −12.6% (−24.8% to -0.5%) | 0.59 (0.36 to 0.99) | 0.044 |
| Stable macular retinal reattachment† | 82/123 (66.7%) | 68/126 (54.0%) | −12.7% (−24.7% to -0.7%) | 0.59 (0.35 to 0.98) | 0.041 |
| Tractional retinal detachment | 30/123 (24.4%) | 35/124 (28.2%) | 4.5% (−6.7% to 15.6%) | 1.22 (0.69 to 2.15) | 0.494 |
| Hypotony (within 6 months)‡ | 28/124 (22.6%) | 31/125 (24.8%) | 2.2% (−8.3% to 12.8%) | 1.13 (0.63 to 2.03) | 0.680 |
| Elevated IOP | 40/127 (31.5%) | 58/125 (46.4%) | 14.9% (3.0% to 26.8%) | 1.88 (1.13 to 3.15) | 0.016 |
| Macular pucker | 25/122 (20.5%) | 37/124 (29.8%) | 9.3% (−1.4% to 20.1%) | 1.65 (0.92 to 2.96) | 0.093 |
| Number of operations to achieve reattachment | 0 (0,0) | 0 (0,1) | 1.15 (0.68 to 1.94) | 0.608 | |
| Median (IQR) | Adjusted* incident rate ratio | ||||
| VFQ-25 AT 6 months | 71.9 (20.9) | 72.0 (20.1) | 0.78 (−3.53 to 5.10) Adjusted* mean difference | 0.723 | |
*Adjusted for centre.
†Without internal tamponade at 6 months.
‡Data taken from secondary outcome form and adverse events form.
ETDRS, Early Treatment Diabetic Retinopathy Study; IOP, intraocular pressure; PVR, proliferative vitreoretinopathy; VFQ, Visual Function Questionnaire.