Table 1.
Outcome measure | Tool | Eye | Baseline | 1 month | 3 months | 6 months | 24 months |
Distance VA | ETDRS charts | Study eye Contralateral eye |
X X |
X X |
X X |
X X |
|
Near VA | Bailey-Lovie charts | Study eye Contralateral eye |
X X |
X X |
X X |
X X |
|
Contrast sensitivity | Pelli-Robson chart | Study eye Contralateral eye |
X X |
X X |
|||
Reading speed | MN Read chart | Study eye Contralateral eye |
X X |
X X |
|||
Stage of FTMH• | Slit-lamp biomicroscopy | Study eye | X | ||||
Status of FTMH | Slit-lamp biomicroscopy+ Colour and red free photographs# |
Study eye Study eye |
X X |
X X |
X X |
X X |
X X |
HRQoL | NEI-VFQ-25 and EQ-5D questionnaires | N/A | X | X | X | ||
Costs: | |||||||
- Primary care | Health Service Utilisation questionnaire |
N/A | X | ||||
- Secondary care | Targeted questions in CRF | N/A | X | X | X | ||
- Participants | Participant Unit Cost questionnaire | N/A | X |
VA = visual acuity; ETDRS = Early Treatment Diabetic Retinopathy Study visual acuity charts; FTMH = full-thickness macular hole; HRQoL = health related quality of life; N/A = not applicable; • = Stage 2: absence of posterior vitreous detachment and whenever the largest diameter of the hole is ≤ 400 microns; Stage 3: absence of posterior hyaloid separation but when the largest diameter of the hole is > 400 microns, as classified by the vitreo-retinal surgeon; + = closed, open with subretinal fluid around it or open with no subretinal fluid around it as determined by the vitreo-retinal surgeon; # = size of the macular hole and status of the macular hole (closed, open with subretinal fluid around it or open with no subretinal fluid around it) as determined by a masked observer at the University of Aberdeen.