Clinical and cost-effectiveness of internal limiting membrane peeling for patients with idiopathic full thickness macular hole. Protocol for a Randomised Controlled Trial: FILMS (Full-thickness macular hole and Internal Limiting Membrane peeling Study)

Table 1 Summary of outcome measures, tools used to obtain them, and eye in which they were assessed at baseline and at each follow-up visit

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.

ISSN: 1745-6215