Intermittent Exotropia
Conditions
Keywords
IXT, intermittent exotropia, occlusion therapy
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).
Interventions
DEVICEEye Patch
adhesive patch to cover eye
Sponsors
Jaeb Center for Health Research
National Eye Institute (NEI)
Pediatric Eye Disease Investigator Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With a Change in Mean Distance Control Scores at 3 Months | 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). |
| Primary Outcome Measure Stratified by Sex | 3 Months | NIH-required analysis. Primary outcome measure (stratified by sex): 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). |
| Primary Outcome Measure Stratified by Race | 3 months | NIH-required analysis. Primary outcome measure (stratified by race): 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). |
| Primary Outcome Measure Stratified by Ethnicity | 3 months | NIH-required analysis. Primary outcome measure (stratified by ethnicity): 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). |
| Primary Outcome: Mean Change in Distance Control Score at 3 Months | 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). |
Countries
United States
Contacts
STUDY_CHAIRStephen P Christiansen, MD
Boston Children's Hospital
STUDY_CHAIRErin C Jenewein, OD
Salus University
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Observation Group Participants randomized to observation alone will not be allowed to receive any other treatment for IXT, except refractive correction, for 3 months. | 37 |
| 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. | 36 |
| Total | 73 |
Baseline characteristics
| Characteristic | Total | Observation Group | Full Time Patching |
|---|---|---|---|
| Age, Customized 3 years old | 10 Participants | 5 Participants | 5 Participants |
| Age, Customized 4 years old | 20 Participants | 8 Participants | 12 Participants |
| Age, Customized 5 years old | 13 Participants | 8 Participants | 5 Participants |
| Age, Customized 6 years old | 11 Participants | 6 Participants | 5 Participants |
| Age, Customized 7 years old | 14 Participants | 8 Participants | 6 Participants |
| Age, Customized 8 years old | 5 Participants | 2 Participants | 3 Participants |
| Average OD/OS Spherical Equivalent Refractive Error, D -0.50 to <0.50 D | 26 Participants | 13 Participants | 13 Participants |
| Average OD/OS Spherical Equivalent Refractive Error, D 0.50 to <2.00D | 38 Participants | 20 Participants | 18 Participants |
| Average OD/OS Spherical Equivalent Refractive Error, D -6.00 to <-0.50 D | 9 Participants | 4 Participants | 5 Participants |
| Average OD/OS Visual Acuity Snellen Equivalent (logMAR) 20/12 (-0.2) | 2 Participants | 1 Participants | 1 Participants |
| Average OD/OS Visual Acuity Snellen Equivalent (logMAR) 20/16 (-0.1) | 18 Participants | 8 Participants | 10 Participants |
| Average OD/OS Visual Acuity Snellen Equivalent (logMAR) 20/20 (0.0) | 18 Participants | 10 Participants | 8 Participants |
| Average OD/OS Visual Acuity Snellen Equivalent (logMAR) 20/25 (0.1) | 20 Participants | 12 Participants | 8 Participants |
| Average OD/OS Visual Acuity Snellen Equivalent (logMAR) 20/32 (0.2) | 8 Participants | 3 Participants | 5 Participants |
| Average OD/OS Visual Acuity Snellen Equivalent (logMAR) 20/40 (0.3) | 6 Participants | 2 Participants | 4 Participants |
| Average OD/OS Visual Acuity Snellen Equivalent (logMAR) 20/50 (0.4) | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 22 Participants | 11 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 51 Participants | 26 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Interocular Difference in Visual Acuity (logMAR lines) One line (1 to <2) | 21 Participants | 10 Participants | 11 Participants |
| Interocular Difference in Visual Acuity (logMAR lines) Two lines (=2) | 7 Participants | 3 Participants | 4 Participants |
| Interocular Difference in Visual Acuity (logMAR lines) Within one line (0 to <1) | 45 Participants | 24 Participants | 21 Participants |
| Neurological Anomaly That Could Affect Ocular Motility? No | 72 Participants | 36 Participants | 36 Participants |
| Neurological Anomaly That Could Affect Ocular Motility? Yes (patient ineligible) | 1 Participants | 1 Participants | 0 Participants |
| Participant Baseline Suppression Scores Dense (3) | 23 Participants | 11 Participants | 12 Participants |
| Participant Baseline Suppression Scores Mild (1) | 10 Participants | 5 Participants | 5 Participants |
| Participant Baseline Suppression Scores Missing (children were unable to understand the test and/or gave unreliable responses) | 11 Participants | 5 Participants | 6 Participants |
| Participant Baseline Suppression Scores Moderate (2) | 16 Participants | 7 Participants | 9 Participants |
| Participant Baseline Suppression Scores Negligible (0) | 13 Participants | 9 Participants | 4 Participants |
| Prior Non-Surgical Treatments for IXT None | 67 Participants | 33 Participants | 34 Participants |
| Prior Non-Surgical Treatments for IXT Overminus > 1 year prior to enrollment | 2 Participants | 1 Participants | 1 Participants |
| Prior Non-Surgical Treatments for IXT Patching > 1 year prior to enrollment | 2 Participants | 1 Participants | 1 Participants |
| Prior Non-Surgical Treatments for IXT Pencil Push-Ups within 1 year prior to enrollment (patient ineligible) | 1 Participants | 1 Participants | 0 Participants |
| Prior Non-Surgical Treatments for IXT Prism > 1 year prior to enrollment | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 8 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) White | 36 Participants | 19 Participants | 17 Participants |
| Sex: Female, Male Female | 45 Participants | 21 Participants | 24 Participants |
| Sex: Female, Male Male | 28 Participants | 16 Participants | 12 Participants |
| Spectacle Status Not wearing spectacles | 52 Participants | 26 Participants | 26 Participants |
| Spectacle Status Wearing spectacles at least two weeks | 21 Participants | 11 Participants | 10 Participants |
| Stereoacuity at near, arcseconds (log10 arcseconds) 100 (2.00) | 12 Participants | 6 Participants | 6 Participants |
| Stereoacuity at near, arcseconds (log10 arcseconds) 200 (2.30) | 8 Participants | 5 Participants | 3 Participants |
| Stereoacuity at near, arcseconds (log10 arcseconds) 400 (2.60) | 7 Participants | 4 Participants | 3 Participants |
| Stereoacuity at near, arcseconds (log10 arcseconds) 40 (1.60) | 13 Participants | 5 Participants | 8 Participants |
| Stereoacuity at near, arcseconds (log10 arcseconds) 60 (1.78) | 21 Participants | 12 Participants | 9 Participants |
| Stereoacuity at near, arcseconds (log10 arcseconds) 800 (2.90) | 4 Participants | 1 Participants | 3 Participants |
| Stereoacuity at near, arcseconds (log10 arcseconds) Nil (3.20) | 4 Participants | 2 Participants | 2 Participants |
| Stereoacuity at near, arcseconds (log10 arcseconds) Unable to Complete pretest | 4 Participants | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 33 |
| other Total, other adverse events | 0 / 35 | 0 / 33 |
| serious Total, serious adverse events | 0 / 35 | 0 / 33 |
Outcome results
Primary
Number of Participants With a 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).
Time frame: 3 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Observation Group | Number of Participants With a Change in Mean Distance Control Scores at 3 Months | 0 to <1 | 13 Participants |
| Observation Group | Number of Participants With a Change in Mean Distance Control Scores at 3 Months | -2 to <-1 | 8 Participants |
| Observation Group | Number of Participants With a Change in Mean Distance Control Scores at 3 Months | 1 to <2 | 4 Participants |
| Observation Group | Number of Participants With a Change in Mean Distance Control Scores at 3 Months | -3 to <-2 | 1 Participants |
| Observation Group | Number of Participants With a Change in Mean Distance Control Scores at 3 Months | -1 to <0 | 7 Participants |
| Observation Group | Number of Participants With a Change in Mean Distance Control Scores at 3 Months | -4 to <-3 | 1 Participants |
| Observation Group | Number of Participants With a Change in Mean Distance Control Scores at 3 Months | 2 to <3 | 1 Participants |
| Full Time Patching | Number of Participants With a Change in Mean Distance Control Scores at 3 Months | -4 to <-3 | 2 Participants |
| Full Time Patching | Number of Participants With a Change in Mean Distance Control Scores at 3 Months | 2 to <3 | 0 Participants |
| Full Time Patching | Number of Participants With a Change in Mean Distance Control Scores at 3 Months | 1 to <2 | 4 Participants |
| Full Time Patching | Number of Participants With a Change in Mean Distance Control Scores at 3 Months | 0 to <1 | 8 Participants |
| Full Time Patching | Number of Participants With a Change in Mean Distance Control Scores at 3 Months | -1 to <0 | 3 Participants |
| Full Time Patching | Number of Participants With a Change in Mean Distance Control Scores at 3 Months | -2 to <-1 | 9 Participants |
| Full Time Patching | Number of Participants With a Change in Mean Distance Control Scores at 3 Months | -3 to <-2 | 7 Participants |