Trial outcomes
Outcome | Analysis | |
Primary objective |
Patient-centred: Vision-specific health profile (NEI-VFQ25) at 24 months | Intention to treat. |
Secondary objectives |
Patient-centred: Patient-reported health status, HUI-3; EQ-5D-5L (5-level), GUI, NEI-VFQ25; patient experience. Clinical: Visual field mean deviation at 24 months. Intraocular pressure; logMAR visual acuity; need for cataract surgery; visual standards for driving; registered visual impairment; safety. Economic: Incremental cost per QALY gained (based on responses to the EQ-5D-5L; HUI-3); incremental cost per QALY gained (based on responses to glaucoma profile instrument (GPI)); incremental costs to the NHS, personal social services and patients. | Profile over time will be analysed by repeated measures using a linear mixed model. Subgroup analyses will explore potential effect modification of gender, age, one or both eyes affected and extent of visual field loss at baseline (<–20 dB, ≥20 dB) on the primary outcomes. |
GPI, glaucoma profile instrument; GUI, Glaucoma Utility Index; HUI-3, Health Utility Index; LogMAR, logarithm of the mean angle of resolution; NEI-VFQ25, National Eye Institute Visual Function Questionnaire (25 items); NHS, National Health Service; QALY, quality-adjusted life-year.