Full-Time Occlusion Therapy for Intermittent Exotropia in Children

Intermittent Exotropia Clinical Trial

— IXT7  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05462821
• Other study ID #: IXT7
• Secondary ID: 2U10EY011751
• Status: Recruiting
• Phase: N/A
• Start date: November 21, 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Jaeb Center for Health Research
• Contact: Raymond T Kraker, MSPH
• Phone: 813-975-8690
• Email: rkraker[@]jaeb.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exotropia
• Intermittent Exotropia

Intervention

Device:
• Eye Patch
adhesive patch to cover eye

Locations

Country	Name	City	State
United States	Univ. of California- Berkeley	Berkeley	California
United States	Michigan College of Optometry at Ferris State Univ	Big Rapids	Michigan
United States	UAB Pediatric Eye Care; Birmingham Health Care	Birmingham	Alabama
United States	Boston Children's Hospital Waltham	Boston	Massachusetts
United States	Boston Medical Center	Boston	Massachusetts
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	Ohio State University College of Optometry	Columbus	Ohio
United States	Southern California College of Optometry	Fullerton	California
United States	University of Houston College of Optometry	Houston	Texas
United States	Univ of California, Irvine- Gavin Herbert Eye Institute	Irvine	California
United States	Children's Mercy Hospitals and Clinics	Kansas City	Missouri
United States	Progressive Eye Care	Lisle	Illinois
United States	Arkansas Childrens	Little Rock	Arkansas
United States	Southern College of Optometry	Memphis	Tennessee
United States	State University of New York, College of Optometry	New York	New York
United States	Virginia Pediatric Eye Center	Norfolk	Virginia
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Salus University/Pennsylvania College of Optometry	Philadelphia	Pennsylvania
United States	Eye Care Associates, Inc.	Poland	Ohio
United States	Casey Eye Institute	Portland	Oregon
United States	Pacific University College of Optometry	Portland	Oregon
United States	Mayo Clinic Department of Ophthalmology	Rochester	Minnesota
United States	University of Arizona	Tucson	Arizona

Sponsors (3)

Lead Sponsor	Collaborator
Jaeb Center for Health Research	National Eye Institute (NEI), Pediatric Eye Disease Investigator Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean distance control scores at 3 months	To determine if participants with IXT undergoing full-time patching have more improvement in mean distance control between baseline and 3 months than participants being observed without treatment.; The Office Control Score provides a rating of exodeviation control on a 0 to 5 scale, in subjects with intermittent exotropia. Scores 3 to 5 reflect the proportion of time a spontaneous manifest exotropia is present during 30 seconds of observation (<50% score 3; >50% score 4; 100% score 5). If no spontaneous manifest exotropia is observed, scores 0 to 2 reflect the longest time to regain fusion after three, 10-second dissociations (>5 seconds score 2; 1-5 seconds score 1; <1 second score 0).	3 months