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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.