Patients recruited from ophthalmic clinics were asked to attend a special session to undertake additional examination. At the routine clinic visit, patients had slit-lamp biomicroscopy, dilated fundus examination, and fluoroscopy (fluorescein angiography or scanning laser ophthalmoscope [SLO], if required). At the special session, measurements of VA and CS were obtained by two senior orthoptists seconded to the study. No measurements involved dilated fundus examinations. Participants recruited from the low-vision database attended the same special sessions and were not reexamined by an ophthalmologist. The low-vision register comprises most patients previously diagnosed with ARMD at the hospital.
Trained interviewers administered the VF-14, a number of preference-based measures (HUI3, EQ-5D, and SF-6D), a visual analog scale (VAS), and TTO by direct elicitation. Sociodemographic data, health, and social services utilization and participation in support groups, were also ascertained. Clinical information including time since diagnosis of ARMD, subtype, previous, or planned photodynamic therapy, previous cataract extraction, training in or use of different low vision aids/techniques for ARMD patients and, the presence of a chronic illness or disability and limitation other than vision problems were obtained as well.
The visual tests and questionnaires were administered by a standard protocol. The study was approved by the South Sheffield Research Ethics Committee and followed the tenets of the Declaration of Helsinki. Patients gave informed written consent before taking part in the study.