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

NCT05527015 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2025-05-31

No results posted yet for this study

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

Interventions

DEVICE

Bifocal Spectacles

Bifocals with a +3.00 Diopter flat top 35

DEVICE

Single Vision Lenses

Single vision lens as prescribed by provider

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • Pediatric Eye Disease Investigator Group

    collaborator NETWORK

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • Michael X Repka, MD, MBA · Wilmer Eye Institute, Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2033-12-31
Completion
2034-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05527015 on ClinicalTrials.gov