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Table 1 Study assessments

From: Adjunctive intraocular and peri-ocular steroid (triamcinolone acetonide) versus standard treatment in eyes undergoing vitreoretinal surgery for open globe trauma (ASCOT): study protocol for a phase III, multi-centre, double-masked randomised controlled trial

  1. The table may be used as a guide and represents routine standard care. Patients may require fewer visits (e.g., if silicone oil tamponade is not used, or more frequent visits as their clinical need arises, such as reoperations). The restrictions on time windows allowed for scheduled visits relate only to data entry points and are highlighted as shaded columns in the table (i.e., baseline, months 3 and 6)
  2. Shaded columns = data collection points (i.e., eCRF completion required); black X = performed as part of routine NHS care; red X = performed in addition to routine care as part of study
  3. Abbreviations: ETDRS VA Early Treatment Diabetic Retinopathy Study visual acuity, IOP intraocular pressure, VFQ-25 25-itemVisual Functioning Questionnaire, EQ-5D EuroQol health questionnaire, CSRI Client Service Receipt Inventory, CRF case report form, PPV pars plana vitrectomy, ROSO removal of silicone oil
  4. aInvestigational medicinal product administration in treatment group
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Trials

ISSN: 1745-6215