Clinical trial NCT05462821: Full-Time Occlusion Therapy for Intermittent Exotropia in Children
Official title: Randomized Trial of Full-Time Occlusion Therapy for Intermittent Exotropia in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Intermittent Exotropia
Keywords: IXT
intermittent exotropia
occlusion therapy
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
name: Pediatric Eye Disease Investigator Group
First posted: 2022-07-18
Enrollment: 73
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: Understanding the effectiveness of intensive patching has important implications for managing children with IXT. If full-time patching is associated with improvement in distance control vs an observation group, then future studies can be conducted to evaluate different durations of full-time patching treatment, whether the effect is maintained off-treatment, and how full-time patching compares to other treatment strategies.

The purpose of this study is to 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 criteria: Inclusion Criteria:

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

1. Age 3 to \< 9 years
2. 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)
3. Age-normal visual acuity in both eyes:

   * 3 years: 20/50 or better (\>=63 letters)
   * 4 years: 20/40 or better (\>=68 letters)
   * 5-6 years: 20/32 or better (\>=73 letters)
   * 7-\<9 years: 20/25 or better (\>=78 letters)
4. 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.
5. Cycloplegic refraction within the last 7 months.
6. Refractive error between -6.00 D SE and +2.00 D SE (inclusive) based on a cycloplegic refraction within 7 months
7. 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
8. 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.
9. Gestational age \> 30 weeks
10. Birth weight \> 1500 grams
11. 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
12. Parent has phone and is willing to be contacted by Jaeb Center staff
13. Relocation outside of area of an active PEDIG site within 3 months not anticipated

Exclusion Criteria:

Individuals meeting any of the following criteria at baseline will be excluded from study participation:

1. Prior strabismus, intraocular, or refractive surgery (including BOTOX injection)
2. Prior nonsurgical treatment for IXT (e.g., patching, vergence therapy, vision therapy/orthoptics, base-in prism, or deliberate overminus (more than 1.00 D) spectacles of \>1week duration within the past year
3. Previous amblyopia treatment other than refractive correction
4. Diplopia more than 2 times per day by parental assessment
5. Paretic or restrictive strabismus
6. Craniofacial malformations affecting the orbits
7. Ocular disorders which would reduce VA (except refractive error)
8. Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities or ADHD are not excluded.
9. Neurological anomaly that could affect ocular motility (e.g., cerebral palsy, Down syndrome)
10. Immediate family member (child or sibling) of any investigative site personnel directly affiliated with this study.
11. Known allergy to adhesive patches.
12. Known allergy to silicone.

Primary outcomes:
measure: Change in mean distance control scores at 3 months
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Pediatric Eye Care; Birmingham Health Care
state: Alabama
city: Little Rock
country: United States
facility: Arkansas Childrens
state: Arkansas
city: Berkeley
country: United States
facility: Univ. of California- Berkeley
state: California
city: Fullerton
country: United States
facility: Southern California College of Optometry
state: California
city: Irvine
country: United States
facility: Univ of California, Irvine- Gavin Herbert Eye Institute
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Health Care, Dept. of Ophthalmology
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Lisle
country: United States
facility: Progressive Eye Care
state: Illinois
city: Bloomington
country: United States
facility: Indiana School of Optometry
state: Indiana
city: Baltimore
country: United States
facility: Wilmer Eye Institute
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Boston Children's Hospital Waltham
state: Massachusetts
city: Big Rapids
country: United States
facility: Michigan College of Optometry at Ferris State Univ
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Department of Ophthalmology
state: Minnesota
city: Kansas City
country: United States
facility: Children's Mercy Hospitals and Clinics
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: State University of New York, College of Optometry
state: New York
city: Durham
country: United States
facility: Duke University Eye Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University College of Optometry
state: Ohio
city: Poland
country: United States
facility: Eye Care Associates, Inc.
state: Ohio
city: Portland
country: United States
facility: Casey Eye Institute
state: Oregon
city: Philadelphia
country: United States
facility: Salus University/Pennsylvania College of Optometry
state: Pennsylvania
city: Memphis
country: United States
facility: Southern College of Optometry
state: Tennessee
city: Norfolk
country: United States
facility: Virginia Pediatric Eye Center
state: Virginia
Study officials:
affiliation: Boston Children's Hospital
name: Stephen P Christiansen, MD
role: STUDY_CHAIR
affiliation: Salus University
name: Erin C Jenewein, OD
role: STUDY_CHAIR
References: