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Base-in Prism Spectacles for Intermittent Exotropia

NCT03998670 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2023-10-04

Study results available
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Summary

The objective of this short-term, pilot randomized trial comparing spectacles with relieving prism to spectacles without prism is to determine whether to proceed to a full-scale, longer-term randomized trial. This decision will be based primarily on assessing the initial (8-week) response to prism by comparing treatment groups on the following outcomes:

* Mean distance intermittent exotropia (IXT) control score (the mean of 3 control scores) (primary outcome)
* The proportion of participants demonstrating a "treatment response," defined as ≥1 point improvement in the mean distance IXT control score without spontaneous exotropia during control testing (secondary outcome)
* The proportion of participants reporting adverse effects and good/excellent spectacle wear compliance

Conditions

  • Exotropia Intermittent

Interventions

DEVICE

Prism Glasses

Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses

DEVICE

Non-Prism Glasses

Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism

Sponsors & Collaborators

  • Pediatric Eye Disease Investigator Group

    collaborator NETWORK

  • National Eye Institute (NEI)

    collaborator NIH

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • David G Morrison, MD · Vanderbilt University Medical Center

  • Allison I Summers, OD, MCR · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2020-07-30
Completion
2020-07-30

Countries

  • United States

Study Locations

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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 NCT03998670 on ClinicalTrials.gov