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A Pilot Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia

NCT02223650 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2017-05-19

Study results available
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Summary

The objective of this short-term, pilot randomized trial comparing 2.50 diopters (D) overminus lens treatment vs. non-overminus (spectacles without overminus or no spectacles) in children with intermittent exotropia (IXT) 3 to \<7 years of age is to determine whether to proceed to a full-scale, longer-term randomized trial.

Conditions

  • Intermittent Exotropia

Interventions

DEVICE

Overminus treatment

2.50D overminus spectacles

DEVICE

Non-overminus treatment

spectacles without overminus or no spectacles

Sponsors & Collaborators

  • Pediatric Eye Disease Investigator Group

    collaborator NETWORK

  • National Eye Institute (NEI)

    collaborator NIH

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • Jonathan M Holmes, MD · Mayo Clinic

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-07-31
Completion
2015-07-31

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 NCT02223650 on ClinicalTrials.gov