N/A N=559 Randomized Single-blind Treatment

Observation Versus Occlusion Therapy for Intermittent Exotropia

Exotropia

Bottom Line

View on ClinicalTrials.gov: NCT01032330 ↗

Enrolled (actual)

559

Serious AEs

0.0%

Results posted

May 2019

Primary outcome: Primary: Deterioration by 6 Months - Older Cohort — 10; 1; 7; 1 Participants — p=0.004

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: occlusion treatment (Device)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Jaeb Center for Health Research
Primary completion: Dec 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Deterioration by 6 Months - Older Cohort	10; 1; 7; 1; 1; 0	0.004 sig
PRIMARY Deterioration by 3 Years - Older Cohort	25; 0	—
PRIMARY Deterioration by 6 Months - Younger Cohort	4; 2; 2; 2; 2; 0	0.27
PRIMARY Deterioration by 3 Years - Younger Cohort	24; 0	—
SECONDARY Distance Stereoacuity - 3 Years	2.03; 0.14	<.001 sig
SECONDARY Near Stereoacuity - 6 Months	1.84; 1.84; 0.00; 0.06	0.38
SECONDARY Near Stereoacuity - 3 Years	1.7; 0.14	<.001 sig
SECONDARY Exotropia Control at Distance - 6 Months	2.3; 2.0; 2.8; 2.3; 0.1; 0.3	0.09
SECONDARY Exotropia Control at Distance - 3 Years	1.8; 2.2; 0.6; 0.2	<.001 sig
SECONDARY Exotropia Control at Near - 6 Months	1.2; 0.9; 1.4; 1.1; -0.2; 0.1	0.013 sig
SECONDARY Exotropia Control at Near - 3 Years	0.9; 1.0; 0.1; 0.1	0.42
SECONDARY PACT Exodeviation at Distance - 6 Months	23.8; 22.2; 27.9; 24.9; -0.3; 1.4	0.012 sig
SECONDARY PACT at Distance - 3 Years	21.0; 23.4; 2.2; 3.6	.002 sig
SECONDARY PACT at Near - 6 Months	17.6; 15.4; 19.3; 17.0; 0.5; 1.5	0.11
SECONDARY PACT at Near - 3 Years	17.0; 14.9; 0.4; 2.8	0.60

Summary

The present study is being conducted to assess the natural history of intermittent exotropia and to establish the effectiveness of occlusion in its treatment. Study Objectives: * To determine the effectiveness of occlusion for the treatment of intermittent exotropia among patients aged 3 to < 11 years who have baseline near stereoacuity of 400 arcsec or better by Preschool Randot stereotest * To determine the natural history of intermittent exotropia among patients aged 3 to < 11 years who have baseline near stereoacuity of 400 arcsec or better by Preschool Randot stereotest

Eligibility Criteria

Inclusion Criteria

Age 12 months to < 11 years
Intermittent exotropia (manifest deviation) meeting all of the following criteria:
Intermittent exotropia at distance OR constant exotropia at distance and either intermittent exotropia or exophoria at near
Exodeviation at least 15PD at distance OR near measured by prism and alternate cover test (PACT)
Exodeviation at least 10PD at distance measured by PACT
No previous surgical or non-surgical treatment for IXT (other than refractive correction)
Visual acuity in the worse eye at least 0.3 logMAR (20/40 on ATS HOTV or 70 letters on E-ETDRS) for children ≥ 3 years of age
No interocular difference of visual acuity more than 0.2 logMAR (2 lines on ATS HOTV or 10 letters on E-ETDRS) for children ≥ 3 years of age
No hyperopia greater than +3.50 D spherical equivalent in either eye
No myopia greater than -6.00 D spherical equivalent in either eye
No prior strabismus, intraocular, or refractive surgery
No abnormality of the cornea, lens, or central retina
Investigator willing to observe the IXT untreated for 3 years unless specific criteria for deterioration are met

Exclusion Criteria

Pure phoria at both distance and near
Prior non-surgical treatment for IXT other than refractive correction (e.g., vergence therapy, occlusion, vision therapy/orthoptics, or deliberate over-minus with spectacles more than 0.50D)
Previous amblyopia treatment other than refractive correction within 1 year
Vision therapy/orthoptics for any reason within the last year
Interocular visual acuity difference more than 0.2 logMAR (2 lines on ATS HOTV for patients 3 to < 7 years old or 10 letters on E-ETDRS for patients ≥ 7 years old) (patients ≥ 3 years only) and/or investigator plans to initiate amblyopia treatment at this time.
Limitation of ocular rotations due to restrictive or paretic strabismus
Craniofacial malformations affecting the orbits
Ocular disorders which would reduce visual acuity (except refractive error)
Prior strabismus surgery or botulinum injection, intraocular surgery, or refractive surgery
Strabismus surgery planned
Known skin reactions to patch or bandage adhesives
Significant neurological impairment such as cerebral palsy. Patients with mild speech delays or common reading and/or learning disabilities are not excluded.
Investigator planning to change refractive correction at this time (if the patient is otherwise eligible, the investigator should consider prescribing refractive correction and bringing the patient back at a later time for enrollment)

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Data sourced from ClinicalTrials.gov (NCT01032330). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.