Intermittent ExotropiaIXT3NCT02223650
A Pilot Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia
A study testing Overminus treatment and Non-overminus treatment in people with Intermittent Exotropia, run by Jaeb Center for Health Research at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Intermittent Exotropia
- What is being tested?
- Overminus treatment and Non-overminus treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2014to Jul 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Marshall B. Ketchum University
Fullerton, California, 92831
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: A Pilot Randomized Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia
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
- Conditions
- Intermittent Exotropia
- Being tested
- Overminus treatment, Non-overminus treatment
- Keywords
- Intermittent Exotropia, IXT, overminus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overminus treatmentDevice
Also called Overminus spectacles, Overminus glasses, Overminus therapy
2.50D overminus spectacles
Non-overminus treatmentDevice
spectacles without overminus or no spectacles
| Study group | Role | What they receive |
|---|---|---|
| Overminus Treatment | Experimental | 2.50D overminus spectacles Receives: Device: Overminus treatment |
| Non-overminus Treatment | Active comparator | spectacles without overminus or no spectacles Receives: Device: Non-overminus treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (12)
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startDec 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intermittent ExotropiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Jonathan M Holmes, MD, Study chair, Mayo ClinicAngela M Chen, OD, MS, Study chair, Marshall B. Ketchum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02223650
- Sponsor's protocol ID
- IXT3
- Other IDs
- 2U10EY011751
- Acronym
- IXT3
- Status last verified
- Apr 2017
- First submitted
- 20 Aug 2014
- Last updated
- 19 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- 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.
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
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia
- ClinicalTrials.gov ID
- NCT02223650
- Acronym / sponsor ID
- IXT3 / IXT3
- Conditions
- Intermittent Exotropia
- Keywords
- Intermittent Exotropia, IXT, overminus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)
- Study start
- Dec 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 22 Aug 2014 (estimated)
- Results
- Posted 20 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Overminus Treatment | Experimental | Device: Overminus treatment2.50D overminus spectacles |
| Non-overminus Treatment | Active comparator | Device: Non-overminus treatmentspectacles without overminus or no spectacles |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Overminus treatmentAlso: Overminus spectacles, Overminus glasses, Overminus therapy2.50D overminus spectacles | Device | Overminus Treatment |
| Non-overminus treatmentspectacles without overminus or no spectacles | Device | Non-overminus Treatment |
Primary outcome
Mean Distance Exotropia Control Score
Time frame: 8 weeks
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.
12 secondary outcomes
Mean Near Exotropia Control Score
Time frame: 8 weeks
Distribution of Distance Control Score at 8-week Outcome
Time frame: 8 weeks
Distribution of Near Control Score at 8-week Outcome
Time frame: 8 weeks
Proportion of Subjects With Distance Control Treatment Response
Time frame: 8 weeks
Symptom Survey Response to Question: Has Child Looked Over His/Her Spectacles Since Enrollment?
Time frame: 8 weeks
Stereoacuity
Time frame: 8 weeks
Distance Visual Acuity
Time frame: 8 weeks
Binocular Near Visual Acuity
Time frame: 8 weeks
Symptom Survey Response to Question: Has Your Child Had Eyestrain (Tired, Sore, or Uncomfortable Eyes)?
Time frame: 8 weeks
Symptom Survey Response to Question: Since Enrollment Has Your Child Avoided Reading or Doing Things up Close?
Time frame: 8 weeks
Symptom Survey Response to Question: Has Your Child Reported Blurry Vision?
Time frame: 8 weeks
Proportion of Subjects With Near Control Treatment Response
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27506485Pediatric 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.
- PEDIG Public WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan M Holmes, MD study chair
Mayo Clinic
Angela M Chen, OD, MS study chair
Marshall B. Ketchum University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Overminus treatment and Non-overminus treatment in people with Intermittent Exotropia, run by Jaeb Center for Health Research at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Distance Exotropia Control Score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02223650, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2017.