Bifocal Spectacles vs. Single Vision Spectacles for Esotropia Greater at Near

NCT05527015 | Withdrawn Phase 3 DMC

• 2 other identifiers: ETS32U10EY011751
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Compare the proportion of BFL and SVL participants with treatment failure by 36 months, compare binocular function test scores between the BFL and SVL groups with both groups in BFL at 38 months after randomization (or 2 months after treatment failure), and evaluate treatment failure by 36 months according to baseline factor subgroups of: duration of constant esotropia pre-enrollment, presence of near stereoacuity on the Randot Preschool Stereoacuity test, in-office response of near alignment with +3.00 D lenses, and gradient AC/A ratio

Conditions

Esotropia

Keywords

esotropia; bifocal

Outcome Measures

Primary Outcomes (1)

• Number of Participants meeting treatment failure at any follow up visit before 36 months

  Failure criteria can be described as 1. Distance motor failure: Constant ET ≥15∆ by simultaneous prism and cover test (SPCT) at distance. 2. Near stereo failure: Decrease in near stereoacuity on the Randot Preschool Stereotest of 2 or more levels from baseline or from 960" at baseline to nil (criteria not applicable if nil near stereo at baseline) 3. Binocular diplopia with a frequency of "more than 2 times per day" over the last week by parental report 4. Nonsurgical or surgical treatment for ET, other than the randomized treatment, is started before a failure criterion is met

  36 months

Study Arms (2)

Single vision spectacles (SVLs)

ACTIVE COMPARATOR

Device: Single Vision Lenses

Bifocal spectacles (BFLs)

EXPERIMENTAL

Device: Bifocal Spectacles

Interventions

Bifocal Spectacles DEVICE

Bifocals with a +3.00 Diopter flat top 35

Bifocal spectacles (BFLs)

Single Vision Lenses DEVICE

Single vision lens as prescribed by provider

Single vision spectacles (SVLs)

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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:

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• National Eye Institute (NEI): collaborator
• Pediatric Eye Disease Investigator Group: collaborator

MeSH Terms

Conditions

Esotropia

Condition Hierarchy (Ancestors)

Strabismus; Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Study Officials

• Michael X Repka, MD, MBA

  Wilmer Eye Institute, Johns Hopkins University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will not be masked to their treatment group, given that their spectacles either will or will not have a visible flat-top bifocal. The investigator treating each participant also will not be masked to treatment group. Therefore, an examiner masked to treatment group will measure eye alignment and stereoacuity at all follow-up visits and conduct the binocular function testing at the required follow-up visits.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Random assignment (1:1) to: * Single vision spectacles (SVLs) * Bifocal spectacles (BFLs): +3.00 D flat-top 35

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 2, 2022
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2033
• Study Completion (Estimated): February 1, 2034
• Last Updated: May 31, 2025

Record last verified: 2025-05