Evaluation of Exotropia After Patching the Eye or After Prism Adaptation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-27

Study Completion Date

2024-09-18

Brief Summary

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This study intends to determine the number and percent of subjects initially diagnosed with divergence excess exotropia which would be reclassified as simulated divergence excess exotropia if tested after 24 hours of monocular occlusion (patching) or after prism adaptation for the distance angle.

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Detailed Description

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Conditions

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Exotropia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patching

Group Type EXPERIMENTAL

Patching

Intervention Type PROCEDURE

The subject will occlude the non-dominant eye for 24 hours.

Prism Adaptation

Group Type EXPERIMENTAL

Prism Adaptation

Intervention Type PROCEDURE

The subject will undergo prism adaptation targeting the pre-occlusion distance angle for 1-2 weeks. • Fresnel prism(s) will be applied to the patient's spectacles equaling the distance angle between the two eyes. At the examiner's discretion depending on the size of the deviation, the prism(s) can be placed solely over the non-dominant eye, or split between the 2 eyes in some combination which results in equalization of the distance exotropia. If the distance angle calls for an amount of prism that cannot be exactly replicated with Fresnel prisms (e.g., 32 PD), the amount of prism used will be determined by rounding down to the nearest practical amount at examiner discretion.

Interventions

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Patching

The subject will occlude the non-dominant eye for 24 hours.

Intervention Type PROCEDURE

Prism Adaptation

The subject will undergo prism adaptation targeting the pre-occlusion distance angle for 1-2 weeks. • Fresnel prism(s) will be applied to the patient's spectacles equaling the distance angle between the two eyes. At the examiner's discretion depending on the size of the deviation, the prism(s) can be placed solely over the non-dominant eye, or split between the 2 eyes in some combination which results in equalization of the distance exotropia. If the distance angle calls for an amount of prism that cannot be exactly replicated with Fresnel prisms (e.g., 32 PD), the amount of prism used will be determined by rounding down to the nearest practical amount at examiner discretion.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with divergence excess exotropia according to standard criteria (see Study Procedures for specifics)
* No prior strabismus surgery
* Able to cooperate with testing (by examiner determination)

Exclusion Criteria

* Not amblyopic at the time of enrollment (best-corrected visual acuity in both eyes of 20/40 or better)
* Under 18 years of age. There is no lower age limit as long as the subject can cooperate for the required testing.
* No diagnosis of dissociated vertical deviation

* No diagnosis of divergence excess exotropia according to standard criteria (see Study Procedures for specifics)
* Prior strabismus surgery
* Unable to cooperate with testing (by examiner determination)
* Best-corrected visual acuity in either eye worse than 20/40
* 18 years of age or older
* Diagnosed with dissociated vertical deviation

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No