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A Pilot Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia | Clinical Trials | Clareo Health

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A Pilot Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia

A Pilot Randomized Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia

NCT02223650•Jaeb Center for Health Research

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.

Detailed Description

The objective of this short-term, pilot randomized trial comparing 2.50D overminus lens treatment vs. non-overminus (spectacles without overminus or no spectacles) 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 overminus by comparing treatment groups on the following outcomes: * Mean distance IXT control score (each patient's score is the mean of 3 control scores) (primary outcome) * The proportion of subjects with treatment response, defined as 1 or more points improvement in mean of 3 distance IXT control scores (secondary outcome) * Adverse effects, near visual acuity outcomes, and spectacle wear compliance

Eligibility

Age

3 - 6 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The following criteria must be met for the child to be enrolled in the study:
•Age 3 years to \< 7 years
•Intermittent exotropia (manifest deviation) meeting all of the following criteria:
•* Intermittent exotropia or constant exotropia at distance
•* Mean distance control score of 2 points or more (mean of 3 assessments over the exam)
•* Intermittent exotropia, exophoria, or orthophoria at near
•* Subject cannot have a score of 5 points on all 3 near assessments of control
•* Exodeviation at least 15∆ at distance measured by PACT
•* Near deviation does not exceed distance deviation by more than 10∆ by PACT (convergence insufficiency type IXT excluded)
•No previous non-surgical treatment for IXT (other than refractive correction), including vision therapy for IXT, within the past 6 months.
+15 more criteria

Exclusion Criteria

•No current contact lens wear
•No abnormality of the cornea, lens, or central retina
•Gestational age ≥ 32 weeks
•Birth weight \> 1500 grams
•No Down syndrome or cerebral palsy
•No severe developmental delay which would interfere with treatment or evaluation (in the opinion of the investigator). Subjects with mild speech delays or reading and/or learning disabilities are not excluded.
•No disease known to affect accommodation, vergence, and ocular motility such as multiple sclerosis, Graves orbitopathy, myasthenia gravis, diabetes mellitus, or Parkinson disease
•No current use of any ocular or systemic medication known to affect accommodation or vergence, such as anti-anxiety agents (e.g., Librium or Valium), anti-arrhythmic agents (e.g., Cifenline, Cibenzoline), anti-cholinergics (e.g., motion sickness patch (scopolamine)), bladder spasmolytic drugs (e.g., Propiverine), hydroxychloroquine, chloroquine, phenothiazines (e.g., Compazine, Mellaril, Thorazine), tricyclic antidepressants (e.g., Elavil, Nortriptyline, Tofranil)
•Parent understands the protocol and is willing to accept randomization to overminus spectacles or non-overminus status
•Parent has home phone (or access to phone) and is willing to be contacted by Jaeb Center staff and Investigator's site staff
+1 more criteria

Locations (2)

Marshall B. Ketchum University

Fullerton, California, United States

Mayo Clinic

Rochester, Minnesota, United States

Key Dates

Start Date

December 1, 2014

Primary Completion Date

July 1, 2015

Completion Date

July 1, 2015

Last Updated

May 19, 2017

Enrollment

ACTUAL participants

Conditions

Intermittent Exotropia

Interventions

Overminus treatment

DEVICE

Non-overminus treatment

DEVICE

Bilateral Lateral Rectus Recession Versus Bilateral Primary Medial Rectus Resection in Intermittent Exotropia

NCT06650735

Intermittent Exotropia

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COMPLETED

A Novel Dynamic Random-dot Stereopsis Assessment to Measure the Stereopsis in Intermittent Exotropia

NCT04152122

Dynamic Stereopsis in Intermittent Exotropia Patients

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UNKNOWN

Overminus Lens Therapy in Intermittent

NCT03952702

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 19, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Pilot Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia

Inclusion Criteria

Exclusion Criteria

Bilateral Lateral Rectus Recession Versus Bilateral Primary Medial Rectus Resection in Intermittent Exotropia

A Novel Dynamic Random-dot Stereopsis Assessment to Measure the Stereopsis in Intermittent Exotropia

Overminus Lens Therapy in Intermittent

The Analysis of Ocular Deviations Between Dominant and Non-dominant Eye Using Video-oculography (VOG) in Intermittent Exotropia

Office Based Vergence and Accommodative Therapy and Intermittent Exotropia

Protective Effect of Biodegradable Collagen Implant (Ologen) in Scleral Thinning After Strabismus Surgery