Randomized Trial of Full-Time Occlusion Therapy for Intermittent Exotropia in Children

Status: Completed
Location: See all (25) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Determine whether full-time patching is more effective than observation for improving distance control of IXT after 3 months of treatment (on-treatment outcome).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 8
Healthy Volunteers: f
View:

• Children under the care of a pediatric optometrist or pediatric ophthalmologist will be eligible for the study if they meet all the following criteria:

• Age 3 to \< 9 years

• IXT meeting all of the following criteria:

‣ Intermittent or constant XT at distance (mean distance control 2.0 or more) with at least 1 control measure of 3, 4 or 5 (i.e., indicating spontaneous tropia)

⁃ Either IXT, exophoria, or orthophoria at near (cannot have control score of 5 on all 3 near assessments)

⁃ Distance exodeviation between 15∆ and 50∆ by PACT

⁃ Near exodeviation between 0∆ and 50∆ by PACT

⁃ Near exodeviation does not exceed distance by more than 10∆ by PACT (convergence insufficiency-type IXT excluded)

• Age-normal visual acuity in both eyes:

‣ 3 years: 20/50 or better (\>=63 letters)

• Interocular difference in distance VA of 2 logMAR lines or less (10 letters or less on E-ETDRS for patients ≥7 years old). Testing by ATS HOTV for participants 3 to \< 7 years old and by E-ETDRS for participants ≥7 years old.

• Cycloplegic refraction within the last 7 months.

• Refractive error between -6.00 D SE and +2.00 D SE (inclusive) based on a cycloplegic refraction within 7 months

• Participants with refractive error meeting any of the following based on a cycloplegic refraction within 6 months must be wearing spectacles for at least 2 weeks:

‣ Myopia \> -0.50 D spherical equivalent (SE) in either eye

⁃ Anisometropia \> 1.00 D SE

⁃ Astigmatism in either eye \> 1.00 D

• Any refractive correction worn at enrollment (required or not) must meet the following guidelines based on a cycloplegic refraction within 7 months:

‣ Anisometropia SE must be within 0.50 D of the full anisometropic difference correction

⁃ Astigmatism must be corrected within 0.50 D

⁃ Axis must be within ±10 degrees if cylinder power is ≤1.00 D and within ±5 degrees if cylinder power is \>1.00 D.

⁃ For hyperopia, the spherical component can be reduced at investigator discretion provided the reduction is symmetrical and does not meet the definition of deliberate overminus (see below).

⁃ For myopia, the intent is to fully correct, but the spherical component can be undercorrected at investigator discretion provided the reduction is symmetrical and results in no more than -0.50 D SE residual (i.e., uncorrected) myopia. Deliberate overminus is not allowed.

⁃ Deliberate overminus is defined for this protocol as any refractive correction prescribed to yield lenses that are overminused by more than -0.50D SE than cycloplegic refraction SE

∙ Less than the full cycloplegic hyperopic correction (i.e., prescribing reduced plus) is not considered the same as overminusing for this protocol (because most patients without IXT but with hyperopic SE refractions up to +2.00 D SE would not typically be prescribed a refractive correction.)

⁃ For refractive errors with an emmetropic or myopic SE, the intent is to fully correct, but the spherical component can be undercorrected at investigator discretion provided the reduction is symmetrical and results in no more than -0.50 D SE residual (i.e., uncorrected) myopia. Prescribing a correction that yields more than 0.50 D more minus SE than the cycloplegic refraction SE is considered deliberate overminus and is not allowed.

⁃ Note that the refractive correction guidelines and the requirement to wear refractive correction for at least 2 weeks apply not only to participants who require refractive correction under the above criteria but also to any other participant who is wearing refractive correction.

• Gestational age \> 30 weeks

⁃ Birth weight \> 1500 grams

⁃ Patient and/or parent understands protocol, is willing to enroll, and is willing to accept that other (i.e., nonrandomized) treatment for IXT will not be offered by the investigator for 3 months

⁃ Parent has phone and is willing to be contacted by Jaeb Center staff

⁃ Relocation outside of area of an active PEDIG site within 3 months not anticipated

Locations
United States
Alabama
UAB Pediatric Eye Care; Birmingham Health Care
Birmingham
Arkansas
Arkansas Childrens
Little Rock
California
Univ. of California- Berkeley
Berkeley
Southern California College of Optometry
Fullerton
Univ of California, Irvine- Gavin Herbert Eye Institute
Irvine
Loma Linda University Health Care, Dept. of Ophthalmology
Loma Linda
Stanford University
Palo Alto
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago
Progressive Eye Care
Lisle
Indiana
Indiana School of Optometry
Bloomington
Massachusetts
Boston Children's Hospital Waltham
Boston
Boston Medical Center
Boston
Maryland
Wilmer Eye Institute
Baltimore
Michigan
Michigan College of Optometry at Ferris State Univ
Big Rapids
Minnesota
Mayo Clinic Department of Ophthalmology
Rochester
Missouri
Children's Mercy Hospitals and Clinics
Kansas City
North Carolina
Duke University Eye Center
Durham
Nebraska
University of Nebraska Medical Center
Omaha
New York
State University of New York, College of Optometry
New York
Ohio
Ohio State University College of Optometry
Columbus
Eye Care Associates, Inc.
Poland
Oregon
Casey Eye Institute
Portland
Pennsylvania
Salus University/Pennsylvania College of Optometry
Philadelphia
Tennessee
Southern College of Optometry
Memphis
Virginia
Virginia Pediatric Eye Center
Norfolk
Time Frame
Start Date: 2022-11-01
Completion Date: 2025-05-01
Participants
Target number of participants: 73
Treatments
No_intervention: Observation Group
Participants randomized to observation alone will not be allowed to receive any other treatment for IXT, except refractive correction, for 3 months.
Experimental: Full Time Patching
Participants randomized to the full-time patching group will patch full-time (all waking hours) for 3 months up until the day before the 3-month primary outcome visit. Daily alternate patching will be prescribed (right eye on even days, left eye on odd days). No other treatment for IXT will be used, except for refractive correction.
Related Therapeutic Areas
Sponsors
Collaborators: Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)
Leads: Jaeb Center for Health Research

This content was sourced from clinicaltrials.gov

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