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Trial of Overminus Spectacle Therapy for Intermittent Exotropia

NCT02807350 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 386

Last updated 2022-06-03

Study results available
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Summary

The main objectives of this randomized trial comparing overminus lens treatment to non-overminus (spectacles without overminus or spectacles with plano lenses) are to determine:

* The long-term on-treatment effect of overminus treatment on distance intermittent exotropia (IXT) control score.
* The off-treatment effect of overminus treatment on distance IXT control score (following weaning and 3 months off treatment).

Conditions

  • Intermittent Exotropia

Interventions

DEVICE

Overminus treatment

spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere

DEVICE

Non-overminus treatment

spectacles with full cycloplegic refraction without overminus

Sponsors & Collaborators

  • Pediatric Eye Disease Investigator Group

    collaborator NETWORK

  • National Eye Institute (NEI)

    collaborator NIH

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • Angela M Chen, OD, MS · Marshall B. Ketchum University

  • S. Ayse Erzurum, MD · Eye Care Associates, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-01-16
Primary Completion
2020-11-30
Completion
2022-02-15

Countries

  • United States
  • Canada

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 NCT02807350 on ClinicalTrials.gov