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Table 1 Schedule of assessments and examination items

From: Clinical Evaluation of MyoCare in Europe (CEME): study protocol for a prospective, multicenter, randomized, double-blinded, and controlled clinical trial

Date/item

Screening

Spectacles dispense

Follow-up

Day − 30 to day 0

V0

V1

V2

V3

V4

V5

V6

Day 0

1 week ± 1 day

3 months ± 15 days

6 months ± 30 days

12 months ± 30 days

18 months ± 30 days

24 months ± 30 days

Informed consent signed

X

       

Basic information

Demographics

X

       

History

X

       

Refraction

Noncycloplegic autorefraction

X

   

X

X

X

X

Subjective refraction

X

   

X

X

X

X

Cycloplegic autorefraction

X

   

X

X

X

X

Visual acuity

Uncorrected visual acuity

X

   

X

X

X

X

Best-corrected visual acuity

X

   

X

X

X

X

Central visual acuity

 

X

 

X

X

X

X

X

Peripheral visual acuity

 

X

 

X

    

Eye examination

Keratometry

X

   

X

X

X

X

Slit lamp examination

X

   

X

X

X

X

Fundus examination

X

       

Intraocular pressure measurement

X

       

Axial length

X

  

X

X

X

X

X

Choroidal thickness

X

   

X

X

X

X

Binocular vision

Accommodative LAG

X

   

X

X

X

X

Monocular estimated method (MEM) retinoscopy

X

   

X

X

X

X

Phoria (distance and near)

X

   

X

X

X

X

Spectacle fitting

Frame position and lens condition

 

X

      

Questionnaires

Lifestyle

X

       

Spectacle lens performance and wearability

 

X

X

X

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