Bifocal Spectacles vs. Single Vision Spectacles for Esotropia Greater at Near (ETS3)
Primary Purpose
Esotropia
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Bifocal Spectacles
Single Vision Lenses
Sponsored by
About this trial
This is an interventional treatment trial for Esotropia focused on measuring esotropia, bifocal
Eligibility Criteria
Inclusion Criteria:
- Age 3 to <9 years
Esodeviation meeting all the following criteria is present in refractive correction (if required or worn)
- Constant or intermittent esotropia ≥10∆ measurable by SPCT at near
Distance esotropia (constant, intermittent), esophoria, or orthophoria, with near esodeviation ≥10∆ larger than distance deviation by PACT
- If constant ET at distance, then must be ≤6∆ by SPCT
- If intermittent ET or esophoric at distance, can be any magnitude at distance (as long as near esodeviation is ≥10∆ larger than distance deviation by PACT)
- Cycloplegic refraction within past 3 months (but not on day of exam)
- Wearing spectacles for at least 4 weeks if refractive error is 0.75 D SE or more
Spectacles (if worn) must meet the following criteria:
- SE refractive error must be corrected within ±0.625 D
- Sphere power must be corrected within ±0.50 D
- Anisometropia must be corrected within ±0.50 D SE
- Cylinder power must be corrected within ±0.50 D
- Cylinder axis must be within ±10 degrees if cylinder power is ≤1.00 D and within ±5 degrees if cylinder power is >1.00 D.
Best-corrected VA meeting the following criteria:
- Better-seeing eye VA is age-normal (see section 2.2)
- IOD in VA within 0.2 logMAR (although previous amblyopia is allowed)
- Worse-seeing eye VA of 20/63 or better
- Investigator and parent willing to forgo treatment of ET other than assigned randomized treatment for 36 months unless failure criteria are met.
- Investigator willing to prescribe BFL-spectacles only (in both treatment groups) for 2 months after meeting failure criteria (if failed prior to 36 months); otherwise, between 36 and 38 months
Exclusion Criteria:
- Previous BFL wear (SVL spectacle wear of any duration is allowed)
- Current or planned contact lens wear over the next 3 years
- Myopic refractive error of more than -6.00 D SE
- Previous strabismus surgery (including Botox injection), intraocular surgery (e.g., laser, anti-VEGF injection, or cataract), extraocular surgery (e.g., scleral buckle), or refractive surgery
- Previous treatment for ET using miotics, VT, or prism within prior 3 months
- Amblyopia treatment other than refractive correction within prior 3 months
- Vertical deviation ≥3Δ at distance or near by PACT
- Oculomotor findings consistent with infantile ET (e.g., latent nystagmus, manifest nystagmus, DVD)
- AV pattern: ≥10∆ difference between upgaze and downgaze by PACT at distance
- Paretic or restrictive strabismus
- Constant exotropia at near when tested through the +3.00 D add (intermittent XT and exophoria are allowed)
- Diplopia "more than 2 times per day" over the last week prior to enrollment by parental report. The frequency of diplopia, if any, must be "2 times or less per day" to be eligible.
- Significant developmental delay that would interfere with child's ability to complete testing
- Neurological conditions that could affect ocular motility (e.g., cerebral palsy, Down syndrome)
- Immediate family member (child or sibling) of any site personnel directly affiliated with the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Single vision spectacles (SVLs)
Bifocal spectacles (BFLs)
Arm Description
Outcomes
Primary Outcome Measures
Number of Participants meeting treatment failure at any follow up visit before 36 months
Failure criteria can be described as
Distance motor failure: Constant ET ≥15∆ by simultaneous prism and cover test (SPCT) at distance.
Near stereo failure: Decrease in near stereoacuity on the Randot Preschool Stereotest of 2 or more levels from baseline or from 960" at baseline to nil (criteria not applicable if nil near stereo at baseline)
Binocular diplopia with a frequency of "more than 2 times per day" over the last week by parental report
Nonsurgical or surgical treatment for ET, other than the randomized treatment, is started before a failure criterion is met
Secondary Outcome Measures
Full Information
NCT ID
NCT05527015
First Posted
August 30, 2022
Last Updated
August 16, 2023
Sponsor
Jaeb Center for Health Research
Collaborators
National Eye Institute (NEI), Pediatric Eye Disease Investigator Group
1. Study Identification
Unique Protocol Identification Number
NCT05527015
Brief Title
Bifocal Spectacles vs. Single Vision Spectacles for Esotropia Greater at Near
Acronym
ETS3
Official Title
Randomized Trial of Bifocal Spectacles vs. Single Vision Spectacles for Esotropia Greater at Near
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
June 2030 (Anticipated)
Study Completion Date
August 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jaeb Center for Health Research
Collaborators
National Eye Institute (NEI), Pediatric Eye Disease Investigator Group
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Compare the proportion of BFL and SVL participants with treatment failure by 36 months, compare binocular function test scores between the BFL and SVL groups with both groups in BFL at 38 months after randomization (or 2 months after treatment failure), and evaluate treatment failure by 36 months according to baseline factor subgroups of: duration of constant esotropia pre-enrollment, presence of near stereoacuity on the Randot Preschool Stereoacuity test, in-office response of near alignment with +3.00 D lenses, and gradient AC/A ratio
Detailed Description
Participants will be randomly assigned to treatment with a BFL or SVL spectacle correction for 3 years. Generally, participants will be followed at 3-month intervals for the first year and every 6 months thereafter until the primary outcome visit at 36 months. At each follow-up visit between 3 months and 36 months, ocular alignment and stereoacuity will be assessed to determine if any of the three study-specified failure criteria have been met (worsening of distance esotropia (ET), reduction in near stereoacuity, or frequent diplopia ("more than 2 times per day" over the last week). The primary outcome is failure at or before 36 months.
If a failure criterion is met between 3 to 30 months, participants randomized to SVLs will be prescribed BFLs and those in BFLs will be prescribed continued BFLs. Participants in both groups will return in BFLs 2 months after failure for a Post-failure Secondary Outcome Visit to determine the child's binocular function, after which the child will be released to treatment at investigator discretion. Participants with confirmed failure who complete the Post-failure Secondary Outcome Exam will return for the 12- and 24-month follow-up visits (abbreviated testing) as well as the 38-month Secondary Outcome Visit (they will not return for the 36-month Primary Outcome visit).
If a failure criterion is not met between 3 to 30 months, participants without confirmed failure will complete the 36-month Primary Outcome Visit, After the 36-month visit, SVL group participants will be prescribed BFLs and BFL participants will continue using BFLs.
All participants (i.e., regardless of failure status) will return for a 38-month Secondary Outcome Visit to assess binocular function.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esotropia
Keywords
esotropia, bifocal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Random assignment (1:1) to:
Single vision spectacles (SVLs)
Bifocal spectacles (BFLs): +3.00 D flat-top 35
Masking
Outcomes Assessor
Masking Description
Participants will not be masked to their treatment group, given that their spectacles either will or will not have a visible flat-top bifocal. The investigator treating each participant also will not be masked to treatment group. Therefore, an examiner masked to treatment group will measure eye alignment and stereoacuity at all follow-up visits and conduct the binocular function testing at the required follow-up visits.
Allocation
Randomized
Enrollment
444 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single vision spectacles (SVLs)
Arm Type
Active Comparator
Arm Title
Bifocal spectacles (BFLs)
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Bifocal Spectacles
Intervention Description
Bifocals with a +3.00 Diopter flat top 35
Intervention Type
Device
Intervention Name(s)
Single Vision Lenses
Intervention Description
Single vision lens as prescribed by provider
Primary Outcome Measure Information:
Title
Number of Participants meeting treatment failure at any follow up visit before 36 months
Description
Failure criteria can be described as
Distance motor failure: Constant ET ≥15∆ by simultaneous prism and cover test (SPCT) at distance.
Near stereo failure: Decrease in near stereoacuity on the Randot Preschool Stereotest of 2 or more levels from baseline or from 960" at baseline to nil (criteria not applicable if nil near stereo at baseline)
Binocular diplopia with a frequency of "more than 2 times per day" over the last week by parental report
Nonsurgical or surgical treatment for ET, other than the randomized treatment, is started before a failure criterion is met
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 3 to <9 years
Esodeviation meeting all the following criteria is present in refractive correction (if required or worn)
Constant or intermittent esotropia ≥10∆ measurable by SPCT at near
Distance esotropia (constant, intermittent), esophoria, or orthophoria, with near esodeviation ≥10∆ larger than distance deviation by PACT
If constant ET at distance, then must be ≤6∆ by SPCT
If intermittent ET or esophoric at distance, can be any magnitude at distance (as long as near esodeviation is ≥10∆ larger than distance deviation by PACT)
Cycloplegic refraction within past 3 months (but not on day of exam)
Wearing spectacles for at least 4 weeks if refractive error is 0.75 D SE or more
Spectacles (if worn) must meet the following criteria:
SE refractive error must be corrected within ±0.625 D
Sphere power must be corrected within ±0.50 D
Anisometropia must be corrected within ±0.50 D SE
Cylinder power must be corrected within ±0.50 D
Cylinder axis must be within ±10 degrees if cylinder power is ≤1.00 D and within ±5 degrees if cylinder power is >1.00 D.
Best-corrected VA meeting the following criteria:
Better-seeing eye VA is age-normal (see section 2.2)
IOD in VA within 0.2 logMAR (although previous amblyopia is allowed)
Worse-seeing eye VA of 20/63 or better
Investigator and parent willing to forgo treatment of ET other than assigned randomized treatment for 36 months unless failure criteria are met.
Investigator willing to prescribe BFL-spectacles only (in both treatment groups) for 2 months after meeting failure criteria (if failed prior to 36 months); otherwise, between 36 and 38 months
Exclusion Criteria:
Previous BFL wear (SVL spectacle wear of any duration is allowed)
Current or planned contact lens wear over the next 3 years
Myopic refractive error of more than -6.00 D SE
Previous strabismus surgery (including Botox injection), intraocular surgery (e.g., laser, anti-VEGF injection, or cataract), extraocular surgery (e.g., scleral buckle), or refractive surgery
Previous treatment for ET using miotics, VT, or prism within prior 3 months
Amblyopia treatment other than refractive correction within prior 3 months
Vertical deviation ≥3Δ at distance or near by PACT
Oculomotor findings consistent with infantile ET (e.g., latent nystagmus, manifest nystagmus, DVD)
AV pattern: ≥10∆ difference between upgaze and downgaze by PACT at distance
Paretic or restrictive strabismus
Constant exotropia at near when tested through the +3.00 D add (intermittent XT and exophoria are allowed)
Diplopia "more than 2 times per day" over the last week prior to enrollment by parental report. The frequency of diplopia, if any, must be "2 times or less per day" to be eligible.
Significant developmental delay that would interfere with child's ability to complete testing
Neurological conditions that could affect ocular motility (e.g., cerebral palsy, Down syndrome)
Immediate family member (child or sibling) of any site personnel directly affiliated with the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raymond T Kraker, MSPH
Phone
8139758690
Email
rkraker@jaeb.org
First Name & Middle Initial & Last Name or Official Title & Degree
Katie Stutz
Phone
8139758690
Email
kstutz@jaeb.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristine B Hopkins, OD, MSPH
Organizational Affiliation
University of Alabama at Birmingham School of Optometry
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Justin D Marsh, MD
Organizational Affiliation
Eye Physicians of Central Florida
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Bifocal Spectacles vs. Single Vision Spectacles for Esotropia Greater at Near
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