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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

From: 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)

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  
  1. 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.