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CompletedNCT02223650IXT3Updated May 19, 2017Results posted

A Pilot Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia

An interventional study of Overminus treatment and Non-overminus treatment in Intermittent Exotropia, sponsored by Jaeb Center for Health Research. Completed at 2 sites in United States. Open to participants aged 3 Years to 6 Years. Per ClinicalTrials.gov, last updated 2017-05-19.

Sponsored by Jaeb Center for Health Research · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
3 Years to 6 Years
Sex
All
01

Study summary

The objective of this short-term, pilot randomized trial comparing 2.50 diopters (D) overminus lens treatment vs. non-overminus (spectacles without overminus or no spectacles) in children with intermittent exotropia (IXT) 3 to \<7 years of age is to determine whether to proceed to a full-scale, longer-term randomized trial.

Read the detailed description

The objective of this short-term, pilot randomized trial comparing 2.50D overminus lens treatment vs. non-overminus (spectacles without overminus or no spectacles) is to determine whether to proceed to a full-scale, longer-term randomized trial. This decision will be based primarily on assessing the initial (8-week) response to overminus by comparing treatment groups on the following outcomes:

  • Mean distance IXT control score (each patient's score is the mean of 3 control scores) (primary outcome)
  • The proportion of subjects with treatment response, defined as 1 or more points improvement in mean of 3 distance IXT control scores (secondary outcome)
  • Adverse effects, near visual acuity outcomes, and spectacle wear compliance
02

Conditions studied

  • Intermittent Exotropia

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Keywords

  • Intermittent Exotropia
  • IXT
  • overminus
03

In context

Exotropia

58 studies on the registry are indexed under Exotropia; 13 are open to participants now.

This study's enrollment of 58 is above the median of 50 across 49 interventional studies indexed under Exotropia.

Browse Exotropia studies →

Lead sponsor

Jaeb Center for Health Research is the lead sponsor of 129 studies on the registry; 16 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.

Browse Jaeb Center for Health Research studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

The following criteria must be met for the child to be enrolled in the study:

  • Age 3 years to \< 7 years

  • Intermittent exotropia (manifest deviation) meeting all of the following criteria:

    • Intermittent exotropia or constant exotropia at distance

      • Mean distance control score of 2 points or more (mean of 3 assessments over the exam)

    • Intermittent exotropia, exophoria, or orthophoria at near

      • Subject cannot have a score of 5 points on all 3 near assessments of control
    • Exodeviation at least 15∆ at distance measured by PACT
    • Near deviation does not exceed distance deviation by more than 10∆ by PACT (convergence insufficiency type IXT excluded)
  • No previous non-surgical treatment for IXT (other than refractive correction), including vision therapy for IXT, within the past 6 months.
  • No previous substantial overminus treatment, defined as wearing spectacles that are overminused by 1.00D SE or more (treatment with lenses overminused by less than 1.00D SE is allowed at any time prior to enrollment).
  • No vision therapy, patching, atropine, or other penalization for amblyopia during the last 2 weeks
  • No prior strabismus, intraocular, or refractive surgery (including BOTOX injection)
  • Cycloplegic refraction within 7 months, but NOT on the day of enrollment
  • Spherical equivalent (SE) in both eyes between -6.00D and +1.00D inclusive
  • Distance visual acuity 0.3 logMAR (20/40) or better (by ATS-HOTV) in both eyes
  • No interocular difference of distance visual acuity more than 0.2 logMAR (2 lines)

  • Child must be wearing refractive correction (pre-study spectacles) for at least 1 week if refractive error (based on cycloplegic refraction performed within 7 months) meets any of the following:

    • SE anisometropia ≥1.00 D
    • Astigmatism ≥1.00 D in either eye
    • SE myopia ≥-0.50 D in either eye

  • Refractive correction must meet the following criteria relative to the cycloplegic refraction:

    • SE anisometropia must be within \<1.0D of the SE anisometropic difference
    • Astigmatism must be within \<1.00D of full magnitude; axis must be within 10 degrees if ≤1.00D, and within 5 degrees if >1.00D.

    • The SE of the spectacles must be within \<1.00D of the full cycloplegic refraction SE.

      • A correction that yields at least 1.00 D more minus SE than the cycloplegic refraction SE is considered previous substantial overminus lens treatment and the patient is not eligible.
  • No current contact lens wear
  • No abnormality of the cornea, lens, or central retina
  • Gestational age ≥ 32 weeks
  • Birth weight > 1500 grams
  • No Down syndrome or cerebral palsy
  • No severe developmental delay which would interfere with treatment or evaluation (in the opinion of the investigator). Subjects with mild speech delays or reading and/or learning disabilities are not excluded.
  • No disease known to affect accommodation, vergence, and ocular motility such as multiple sclerosis, Graves orbitopathy, myasthenia gravis, diabetes mellitus, or Parkinson disease
  • No current use of any ocular or systemic medication known to affect accommodation or vergence, such as anti-anxiety agents (e.g., Librium or Valium), anti-arrhythmic agents (e.g., Cifenline, Cibenzoline), anti-cholinergics (e.g., motion sickness patch (scopolamine)), bladder spasmolytic drugs (e.g., Propiverine), hydroxychloroquine, chloroquine, phenothiazines (e.g., Compazine, Mellaril, Thorazine), tricyclic antidepressants (e.g., Elavil, Nortriptyline, Tofranil)
  • Parent understands the protocol and is willing to accept randomization to overminus spectacles or non-overminus status
  • Parent has home phone (or access to phone) and is willing to be contacted by Jaeb Center staff and Investigator's site staff
  • Relocation outside of area of an active PEDIG site within next 8 weeks is not anticipated
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
58 participants (actual)

Study arms

  • Experimental
    Overminus Treatment

    2.50D overminus spectacles

    Device: Overminus treatment

  • Active comparator
    Non-overminus Treatment

    spectacles without overminus or no spectacles

    Device: Non-overminus treatment

Interventions

  • DeviceOverminus treatment

    2.50D overminus spectacles

    Also known as: Overminus spectacles, Overminus glasses, Overminus therapy

  • DeviceNon-overminus treatment

    spectacles without overminus or no spectacles

06

What researchers measure

Primary outcomes

  1. Mean Distance Exotropia Control Score

    At each visit, control of the exodeviation was measured at distance (6 meters) and at near (1/3 meters) using the Office Control Score\* which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a "triple control score," which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The primary analysis was an intention-to-treat treatment group comparison of mean 8-week distance control using an analysis of covariance (ANCOVA) model which adjusted for baseline distance control. \*Mohney BG, Holmes JM. An office-based scale for assessing control in intermittent exotropia. Strabismus 2006;14(3):147-50.

    Time frame: 8 weeks

Secondary outcomes

  1. Mean Near Exotropia Control Score

    At each visit, control of the exodeviation was measured at near (1/3 meters) using the Office Control Score which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a "triple control score," which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The secondary analysis was an intention-to-treat treatment group comparison of mean 8-week near control using an analysis of covariance (ANCOVA) model which adjusted for baseline near control.

    Time frame: 8 weeks

  2. Distribution of Distance Control Score at 8-week Outcome

    Control of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.

    Time frame: 8 weeks

  3. Distribution of Near Control Score at 8-week Outcome

    Control of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.

    Time frame: 8 weeks

  4. Proportion of Subjects With Distance Control Treatment Response

    A comparison of the proportion of subjects showing a "treatment response," defined as an improvement of at least 1 point in distance control (mean of the 3 assessments over the exam) between enrollment and 8 weeks.

    Time frame: 8 weeks

  5. Symptom Survey Response to Question: Has Child Looked Over His/Her Spectacles Since Enrollment?

    A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.

    Time frame: 8 weeks

  6. Stereoacuity

    Stereoacuity will be assessed with habitual correction using the Randot Preschool stereotest at near (performed at 40 cm). A specific level of stereoacuity is not required for eligibility.

    Time frame: 8 weeks

  7. Distance Visual Acuity

    Monocular distance visual acuity testing with the habitual correction and without cycloplegia was measured using the Amblyopia Treatment Study HOTV testing protocol on any certified visual acuity system. The treatment groups were not different with respect to 8-week control PACT at distance

    Time frame: 8 weeks

  8. Binocular Near Visual Acuity

    Binocular near visual acuity was tested in habitual correction using the ATS4 near visual acuity test. The treatment groups were not different with respect to 8-week control at near.

    Time frame: 8 weeks

  9. Symptom Survey Response to Question: Has Your Child Had Eyestrain (Tired, Sore, or Uncomfortable Eyes)?

    A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.

    Time frame: 8 weeks

  10. Symptom Survey Response to Question: Since Enrollment Has Your Child Avoided Reading or Doing Things up Close?

    A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.

    Time frame: 8 weeks

  11. Symptom Survey Response to Question: Has Your Child Reported Blurry Vision?

    A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.

    Time frame: 8 weeks

  12. Proportion of Subjects With Near Control Treatment Response

    A comparison of the proportion of subjects showing a "treatment response," defined as an improvement of at least 1 point in near control (mean of the 3 assessments over the exam) between enrollment and 8 weeks.

    Time frame: 8 weeks

07

Results

Posted Dec 20, 2016
Limitations and caveats
Small sample size; only 8-weeks of follow up; high test-retest variability of control; some regression to the mean may be present; do not know if treatment effect would persist after overminus lenses are replaced with usual spectacle correction.

Participant flow

Between December 2014 and May 2015, 58 children were enrolled at 21 sites, with 31 participants assigned to observation and 27 to overminus treatment.

Participant flow — Overall Study
MilestoneOverminus TreatmentNon-overminus Treatment
Started2731
Completed2731
Not completed00

Outcome measures

PrimaryMean Distance Exotropia Control Score

At each visit, control of the exodeviation was measured at distance (6 meters) and at near (1/3 meters) using the Office Control Score\* which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a "triple control score," which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The primary analysis was an intention-to-treat treatment group comparison of mean 8-week distance control using an analysis of covariance (ANCOVA) model which adjusted for baseline distance control. \*Mohney BG, Holmes JM. An office-based scale for assessing control in intermittent exotropia. Strabismus 2006;14(3):147-50.

Time frame:
8 weeks
Reported as:
Mean · points on control score scale
Mean Distance Exotropia Control Score
points on control score scaleOverminus TreatmentNon-overminus Treatment
Mean Distance Exotropia Control Score2.0 ± 1.42.8 ± 1.4
Statistical analysis
  • Overminus Treatment vs Non-overminus Treatment · ANCOVA · p = 0.01 (P-value is calculated for one-sided hypothesis test.) · Mean difference (final values): -0.75 · 95% CI -1.42 to -0.07Difference in mean distance control (overminus - observation) and 95% CI from ANCOVA model adjusting for baseline control, pre-study spectacle wear, and pre-study treatment for IXT. + difference suggests observation group worse than overminus group
SecondaryMean Near Exotropia Control Score

At each visit, control of the exodeviation was measured at near (1/3 meters) using the Office Control Score which ranges from 0 (phoria, best control) to 5 (constant exotropia, worst control). Due to the variability of single measures of control, we used a "triple control score," which is a mean of 3 measures obtained at specific time-points during a 20- to 40-minute office examination. The secondary analysis was an intention-to-treat treatment group comparison of mean 8-week near control using an analysis of covariance (ANCOVA) model which adjusted for baseline near control.

Time frame:
8 weeks
Reported as:
Mean · points on control score scale
Mean Near Exotropia Control Score
points on control score scaleOverminus TreatmentNon-overminus Treatment
Mean Near Exotropia Control Score0.9 ± 1.21.2 ± 1.1
Statistical analysis
  • Overminus Treatment vs Non-overminus Treatment · ANCOVA · p = 0.14 (P-value is calculated for one-sided hypothesis test.) · Mean difference (final values): -0.24 · 95% CI -0.68 to 0.19Comparison of mean 8-wk distance control using ANCOVA adjusted for baseline near control pre-study spectacle wear, and pre-study IXT treatment.
SecondaryDistribution of Distance Control Score at 8-week Outcome

Control of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.

Time frame:
8 weeks
Reported as:
Number · participants
Distribution of Distance Control Score at 8-week Outcome
participantsOverminus TreatmentNon-overminus Treatment
0 to <141
1 to <2117
2 to <3510
3 to <413
4 to 5610
SecondaryDistribution of Near Control Score at 8-week Outcome

Control of exodeviation will be assessed in the habitual correction at distance (6 meters) and near (1/3 meter) using a standardized IXT control scale.

Time frame:
8 weeks
Reported as:
Number · participants
Distribution of Near Control Score at 8-week Outcome
participantsOverminus TreatmentNon-overminus Treatment
0 to <11510
1 to <2713
2 to <323
3 to <425
4 to 510
SecondaryProportion of Subjects With Distance Control Treatment Response

A comparison of the proportion of subjects showing a "treatment response," defined as an improvement of at least 1 point in distance control (mean of the 3 assessments over the exam) between enrollment and 8 weeks.

Time frame:
8 weeks
Reported as:
Number · participants
Proportion of Subjects With Distance Control Treatment Response
participantsOverminus TreatmentNon-overminus Treatment
Proportion of Subjects With Distance Control Treatment Response1612
Statistical analysis
  • Overminus Treatment vs Non-overminus Treatment · Chi-squared · p = 0.07 (The p-value was not adjusted for multiple comparisons.) · Risk difference (rd): 21 · 95% CI -6 to 45
SecondarySymptom Survey Response to Question: Has Child Looked Over His/Her Spectacles Since Enrollment?

A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.

Time frame:
8 weeks
Reported as:
Number · participants
Symptom Survey Response to Question: Has Child Looked Over His/Her Spectacles Since Enrollment?
participantsOverminus TreatmentNon-overminus Treatment
Looked over specatcles: Always00
Looked over specatcles: Often31
Looked over specatcles: Sometimes72
Looked over specatcles: Rarely22
Looked over specatcles: Never155
SecondaryStereoacuity

Stereoacuity will be assessed with habitual correction using the Randot Preschool stereotest at near (performed at 40 cm). A specific level of stereoacuity is not required for eligibility.

Time frame:
8 weeks
Reported as:
Mean · log arcsecond
Stereoacuity
log arcsecondOverminus TreatmentNon-overminus Treatment
Stereoacuity2.2 ± 0.52.2 ± 0.6
SecondaryDistance Visual Acuity

Monocular distance visual acuity testing with the habitual correction and without cycloplegia was measured using the Amblyopia Treatment Study HOTV testing protocol on any certified visual acuity system. The treatment groups were not different with respect to 8-week control PACT at distance

Time frame:
8 weeks
Reported as:
Mean · prism diopters
Distance Visual Acuity
prism dioptersOverminus TreatmentNon-overminus Treatment
Distance Visual Acuity21.1 ± 11.223.0 ± 6.3
SecondaryBinocular Near Visual Acuity

Binocular near visual acuity was tested in habitual correction using the ATS4 near visual acuity test. The treatment groups were not different with respect to 8-week control at near.

Time frame:
8 weeks
Reported as:
Mean · prism diopters
Binocular Near Visual Acuity
prism dioptersOverminus TreatmentNon-overminus Treatment
Binocular Near Visual Acuity12.8 ± 8.316.9 ± 8.4
SecondarySymptom Survey Response to Question: Has Your Child Had Eyestrain (Tired, Sore, or Uncomfortable Eyes)?

A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.

Time frame:
8 weeks
Reported as:
Number · participants
Symptom Survey Response to Question: Has Your Child Had Eyestrain (Tired, Sore, or Uncomfortable Eyes)?
participantsOverminus TreatmentNon-overminus Treatment
Always00
Often00
Sometimes43
Rarely54
Never1824
SecondarySymptom Survey Response to Question: Since Enrollment Has Your Child Avoided Reading or Doing Things up Close?

A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.

Time frame:
8 weeks
Reported as:
Number · participants
Symptom Survey Response to Question: Since Enrollment Has Your Child Avoided Reading or Doing Things up Close?
participantsOverminus TreatmentNon-overminus Treatment
Always00
Often00
Sometimes11
Rarely02
Never2628
SecondarySymptom Survey Response to Question: Has Your Child Reported Blurry Vision?

A brief survey of symptoms that may be associated with overminus such as headaches, eye strain, and problems with spectacle wear will be administered to the parents of the subjects. Parents are asked to respond to the survey questions based on their observations of their child in the past 2 weeks. Response options are based on frequency of observations; never, rarely, sometimes, often, always, and not applicable. Survey items were derived based on expert opinion of pediatric ophthalmologists and optometrists on the study planning committee. The response options were a 5-point Likert-type scale based on frequency of observations: never = score of 0, almost never = 1, sometimes = 2, often = 3, and always = 4.

Time frame:
8 weeks
Reported as:
Number · participants
Symptom Survey Response to Question: Has Your Child Reported Blurry Vision?
participantsOverminus TreatmentNon-overminus Treatment
Always00
Often00
Sometimes11
Rarely11
Never2529
SecondaryProportion of Subjects With Near Control Treatment Response

A comparison of the proportion of subjects showing a "treatment response," defined as an improvement of at least 1 point in near control (mean of the 3 assessments over the exam) between enrollment and 8 weeks.

Time frame:
8 weeks
Reported as:
Number · participants
Proportion of Subjects With Near Control Treatment Response
participantsOverminus TreatmentNon-overminus Treatment
Proportion of Subjects With Near Control Treatment Response78
Statistical analysis
  • Overminus Treatment vs Non-overminus Treatment · Chi-squared · p = 0.54 (The p-value was not adjusted for multiple comparisons.) · Risk difference (rd): 0.001 · 95% CI -23 to 24

Adverse events

Collected over Baseline to 8 weeks after randomization.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Overminus Treatment—0/27 (0%)3/27 (11.1%)
Non-overminus Treatment—0/31 (0%)2/31 (6.5%)
Most frequent other events
Most frequent other events
EventOverminus TreatmentNon-overminus Treatment
Reduction in monocular distance visual acuity >=2 linesEye disorders2/271/31
Development of esodeviationEye disorders1/270/31
Reduction in binocular near visual acuity >=2 linesEye disorders0/271/31

Baseline characteristics

Age, Continuous
Age, Continuous(years)Overminus TreatmentNon-overminus TreatmentTotal
Mean5.2 ± 15.1 ± 1.25.1 ± 1.1
Age, Customized
Age, Customized(participants)Overminus TreatmentNon-overminus TreatmentTotal
3 to <4 years7310
4 to <5 years41115
5 to <6 years91019
6 to <7 years7714
Sex: Female, Male
Sex: Female, Male(Participants)Overminus TreatmentNon-overminus TreatmentTotal
Female181836
Male91322
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Overminus TreatmentNon-overminus TreatmentTotal
White141529
Black/African American246
Hispanic or Latino6915
Asian538
Refractive error in more myopic eye (spherical equivalent, D)
Refractive error in more myopic eye (spherical equivalent, D)(participants)Overminus TreatmentNon-overminus TreatmentTotal
>+0.50 to +1.00131528
0 to +0.505914
<0 to >-0.50213
-0.50 to >-1.00415
-1.00 to >-1.50101
-1.50 to >-2.00101
-2.00 to >-2.50022
-2.50 to >-3.00022
<=-3.00112
Accommodative convergence over accommodation (AC/A) ratio
Accommodative convergence over accommodation (AC/A) ratio(participants)Overminus TreatmentNon-overminus TreatmentTotal
<2.5121325
2.5 to 6.0121527
>6.0336
08

Study locations

2 sites
  • Marshall B. Ketchum University
    Fullerton, California 92831, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
09

References and documents

Publications

  • Pediatric Eye Disease Investigator Group; Chen AM, Holmes JM, Chandler DL, Patel RA, Gray ME, Erzurum SA, Wallace DK, Kraker RT, Jensen AA. A Randomized Trial Evaluating Short-term Effectiveness of Overminus Lenses in Children 3 to 6 Years of Age with Intermittent Exotropia. Ophthalmology. 2016 Oct;123(10):2127-36. doi: 10.1016/j.ophtha.2016.06.042. Epub 2016 Aug 6. PubMed 27506485 ↗

Individual participant data

Plan to share: Yes — In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the PEDIG public website after the completion of each protocol and publication of the primary manuscript.

10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2014, a primary completion of Jul 2015 and a completion of Jul 2015. It does not say whether these dates are actual or estimated.

Results were first posted in Dec 2016, 1 year 5 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 20, 2014
First posted
Aug 22, 2014
Start
Dec 2014
Primary completionActual
Jul 2015
CompletionActual
Jul 2015
Results first posted
Dec 20, 2016
Last update
May 19, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 19, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02223650
Lead sponsor
Jaeb Center for Health Research
Collaborators
Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)
Responsible party
Sponsor
First posted
Aug 22, 2014
Start date
Dec 2014
Primary completion
Jul 2015
Completion
Jul 2015
Results posted
Dec 20, 2016
Last update
May 19, 2017

Study contacts

Jonathan M Holmes, MD
study chair · Mayo Clinic
Angela M Chen, OD, MS
study chair · Marshall B. Ketchum University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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