Key secondary endpoints evaluated in the VIPER study
| Endpoint | Measurement variable | Analysis metric | Method of aggregation | Time |
|---|---|---|---|---|
| Visual acuity | LogMAR visus using ETDRS charts | Change from baseline | Means | At 26 weeks post-surgery |
| Refractive status | Sphere (D), cylinder (D), axis (°A) | Change from baseline | Means | At 26 weeks post-surgery |
| Intraocular pressure | Tonometry (mm Hg) | Change from baseline | Means | At 26 weeks post-surgery |
| Retina re-attachment | … | Value (yes/no) | Proportions | At surgery At 26 weeks post-surgery |
| Retina-specific procedures | … to achieve a stable retinal attachment | Value (yes/no) Count (>0) | Centiles Proportions | Within 26 weeks |
| Proliferative vitreoretinopathy grade C | … according to Machemer | Value (yes/no) | Proportions | Within 26 weeks |
| Operation time | Time between cut and suture | Value | Means | At surgery |
| Anatomical situation | … of lids, conjunctiva, cornea, anterior chamber, iris, intraocular lens or vitreous cavity | Value (yes/no) Count (>0) | Centiles Proportions | Within 26 weeks |
| Intraoperative complications | … as iatrogenic breaks, bleeding, sclera perforation | Value (yes/no) Count (>0) | Centiles Proportions | At surgery |
| Postoperative complications | … as macular pucker, macular oedema, ocular hypertony, diplopia | Value (yes/no) Count (>0) | Centiles Proportions | Within 26 weeks |
| Enucleation | … | Value (yes/no) | Proportions | Within 26 weeks |
| Death | … | Time to event Value (yes/no) | Centiles Proportions | Within 26 weeks |