Observation Versus Occlusion Therapy for Intermittent Exotropia

Completed · Not applicable

Conditions studied: Exotropia

In brief

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

Key facts

Study ID

NCT01032330

Run by

Jaeb Center for Health Research

People needed

611

Starts

2010-01-01

Expected to finish

2015-12-01

Last updated by the study team

2020-05-19

Who can join

Age: 1 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Southern California College of Optometry — Fullerton, California, United States
• Mayo Clinic Department of Ophthalmology — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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