Bifocal Spectacles vs. Single Vision Spectacles for Esotropia Greater at Near (ETS3)

This is an interventional treatment trial for Esotropia focused on measuring esotropia, bifocal Read More

Inclusion Criteria:

• Age 3 to <9 years

• Esodeviation meeting all the following criteria is present in refractive correction (if required or worn)

  • Constant or intermittent esotropia ≥10∆ measurable by SPCT at near

  • Distance esotropia (constant, intermittent), esophoria, or orthophoria, with near esodeviation ≥10∆ larger than distance deviation by PACT

    • If constant ET at distance, then must be ≤6∆ by SPCT
    • If intermittent ET or esophoric at distance, can be any magnitude at distance (as long as near esodeviation is ≥10∆ larger than distance deviation by PACT)
• Cycloplegic refraction within past 3 months (but not on day of exam)
• Wearing spectacles for at least 4 weeks if refractive error is 0.75 D SE or more

• Spectacles (if worn) must meet the following criteria:

  • SE refractive error must be corrected within ±0.625 D
  • Sphere power must be corrected within ±0.50 D
  • Anisometropia must be corrected within ±0.50 D SE
  • Cylinder power must be corrected within ±0.50 D
  • Cylinder axis must be within ±10 degrees if cylinder power is ≤1.00 D and within ±5 degrees if cylinder power is >1.00 D.

• Best-corrected VA meeting the following criteria:

  • Better-seeing eye VA is age-normal (see section 2.2)
  • IOD in VA within 0.2 logMAR (although previous amblyopia is allowed)
  • Worse-seeing eye VA of 20/63 or better
• Investigator and parent willing to forgo treatment of ET other than assigned randomized treatment for 36 months unless failure criteria are met.
• Investigator willing to prescribe BFL-spectacles only (in both treatment groups) for 2 months after meeting failure criteria (if failed prior to 36 months); otherwise, between 36 and 38 months

Exclusion Criteria:

• Previous BFL wear (SVL spectacle wear of any duration is allowed)
• Current or planned contact lens wear over the next 3 years
• Myopic refractive error of more than -6.00 D SE
• Previous strabismus surgery (including Botox injection), intraocular surgery (e.g., laser, anti-VEGF injection, or cataract), extraocular surgery (e.g., scleral buckle), or refractive surgery
• Previous treatment for ET using miotics, VT, or prism within prior 3 months
• Amblyopia treatment other than refractive correction within prior 3 months
• Vertical deviation ≥3Δ at distance or near by PACT
• Oculomotor findings consistent with infantile ET (e.g., latent nystagmus, manifest nystagmus, DVD)
• AV pattern: ≥10∆ difference between upgaze and downgaze by PACT at distance
• Paretic or restrictive strabismus
• Constant exotropia at near when tested through the +3.00 D add (intermittent XT and exophoria are allowed)
• Diplopia "more than 2 times per day" over the last week prior to enrollment by parental report. The frequency of diplopia, if any, must be "2 times or less per day" to be eligible.
• Significant developmental delay that would interfere with child's ability to complete testing
• Neurological conditions that could affect ocular motility (e.g., cerebral palsy, Down syndrome)
• Immediate family member (child or sibling) of any site personnel directly affiliated with the study