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Table 1 Table of inclusion and exclusion criteria for the three groups in the clinical trial

From: Clinical investigation plan for the use of interactive binocular treatment (I-BiT) for the management of anisometropic, strabismic and mixed amblyopia in children aged 3.5–12 years: a randomised controlled trial

Group 1

Group 2

Group 3

Anisometropic amblyopia

Strabismic or mixed amblyopia

Post-strabismus surgery

Inclusion criteria

 3.55–124 years

3.55–124 years

3.55–124

 Vision in amblyopic eye between 0.3 and 1.3 logMAR with an intraocular difference of 0.2 logMAR or more

Vision in amblyopic eye between 0.3 and 1.3 logMAR with an intraocular difference of 0.2 logMAR or more

Vision in amblyopic eye between 0.3 and 1.3 logMAR with an intraocular difference of 0.2 logMAR or more

 May have a manifest squint of less than or equal to 10 prism dioptres

Manifest squint must be greater than 10 prism dioptres

Residual squint following surgery (no more than 4 weeks prior) of any size

 Undergone refractive adaptation1

Undergone refractive adaptation (if indicated)1,2

Undergone refractive adaptation (if indicated) 1,2

 No previous patching or penalisation

Previous patching or penalisation acceptable

Previous patching or penalisation acceptable

 No previous strabismus surgery

No previous strabismus surgery

Treatment to start within 4 weeks of strabismus surgery but no previous strabismus surgery

 Can use I-BiT Plus

Can use I-BiT Plus

Can use I-BiT Plus

Exclusion criteria

 Deprivational amblyopia

 Presence of manifest nystagmus

 Other ocular or neurological disease affecting the visual system3

 Parent, guardian or child not prepared to give consent

  1. 1Refractive adaptation is wearing refractive correction for a minimum of 12 weeks
  2. 2Refractive adaptation is indicated if there is a significant refractive error
  3. 3These include Down’s syndrome, developmental delay, craniofacial syndrome, foetal alcohol syndrome and cerebral palsy among other conditions
  4. 4The upper limit of the age range is 1 day before their 13th birthday
  5. 5The lower limit of the age range is 182 days after their third birthday