Intermittent ExotropiaIXT5NCT02807350
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 61 sites in 2 countries.
Trial summary
The main objectives of this randomized trial comparing overminus lens treatment to non-overminus (spectacles without overminus or spectacles with plano lenses) are to determine: The long-term on-treatment effect of overminus treatment on distance intermittent exotropia (IXT) control score. Read more about this study
- Who is it for?
- Ages 3 to 10 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
- 386 participants
- Where
- 61 sitesin 2 countries
- Study dates
- 16 Jan 2017to 15 Feb 2022
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 3 years to < 11 years
- Intermittent exotropia (manifest deviation) meeting all of the following criteria:
- At distance: intermittent exotropia or constant exotropia
- o Mean distance control score of 2 points or more (mean of 3 assessments over the exam)
- At near: intermittent exotropia, exophoria, or orthophoria
- o Subject cannot have a score of 5 points on all 3 near assessments of control
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- 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)
- Distance visual acuity (any optotype method) in each eye of 0.4 logMAR (20/50) or better if age 3 years and 0.3 logMAR (20/40) or better if 4 years or older.
- Interocular difference of distance visual acuity ≤0.2 logMAR (2 lines on a logMAR chart)
- Refractive error between -6.00 diopters (D) standard error (SE) and +1.00D SE (inclusive) in the most myopic / least hyperopic eye based on a cycloplegic refraction performed within the past 2 months or at the end of the enrollment exam.
- If refractive error (based on cycloplegic refraction performed within past 2 months or at the end of the enrollment exam) meets any of the following criteria, then pre-study spectacles are required and must have been worn for at least 1 week prior to enrollment:
- SE anisometropia ≥1.00D
- Astigmatism ≥1.50D in either eye
- SE myopia ≥-1.00D in either eye
- Pre-study refractive correction, if worn, must meet the following criteria relative to the cycloplegic refraction performed within past 2 months or at the end of the enrollment exam:
- SE anisometropia must be corrected within <1.00D of the SE anisometropic difference
- Astigmatism must be corrected within <1.00D of full magnitude; axis must be within 10 degrees.
- The SE of the spectacles must not meet the definition of substantial overminus (see exclusion criteria below)
- Gestational age ≥ 32 weeks
- Birth weight > 1500 grams
- Parent understands the protocol and is willing to accept randomization to overminus spectacles or non-overminus spectacles
- 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 18 months is not anticipated
Who cannot join
- Treatment for IXT or amblyopia (other than refractive correction) within the past 4 weeks, including vision therapy, patching, atropine, or other penalization.
- Current contact lens wear
- Substantial deliberate overminus treatment within the past 6 months, defined as spectacles overminused by more than 1.00D SE than the cycloplegic refractive error (within 2 months or at the end of the enrollment exam)
- Prior strabismus, intraocular, or refractive surgery (including BOTOX injection)
- Abnormality of the cornea, lens, or central retina
- Down syndrome or cerebral palsy
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- 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.
- Any disease known to affect accommodation, vergence, and ocular motility such as multiple sclerosis, Graves orbitopathy, dysautonomia, myasthenia gravis, or current use of atropine for amblyopia
- Anti-seizure medications [e.g., carbamazepine (Tegretol, Carbatrol, Epitol, or Equetro), diazepam (Valium or Diastat), clobazam (Frisium or Onfri), clonazepam (Klonopin), lorazepam (Ativan), ethosuximide (Zarontin), felbamate (Felbatol), lacosamide (VIMPAT), gabapentin (Neurontin), oxcarbazepine (Oxtellar XR or Trileptal), phenobarbital, phenytoin (Dilantin or Phenytek), pregabalin (Lyrica), tiagabine (Gabitril), topiramate (Topamax), valproate (Depakote), or zonisamide (Zonegran), vigabatrin (Sabril)]
Trial locations and contacts
61 sites in 2 countries.
61 sites in 2 countries
United States59 sites
Akron Children's Hospital
Akron, Ohio, 44308
University Eye Center at Ketchum Health
Anaheim, California, 92807
The Emory Eye Center
Atlanta, Georgia, 30322
Greater Baltimore Medical Center
Baltimore, Maryland, 21204-5809
Wilmer Eye Institute
Baltimore, Maryland, 21287-9028
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Indiana University School Of Optometry
Bloomington, Indiana, 47405
St Luke's Hospital
Boise, Idaho, 83702
Tufts Medical Center
Boston, Massachusetts, 02111
Boston Medical Center
Boston, Massachusetts, 02118
Medical University of South Carolina, Storm Eye Institute
Charleston, South Carolina, 29425
Pediatric Eye Specialists
Chattanooga, Tennessee, 37421
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Illinois College of Optometry
Chicago, Illinois, 60616
The Eye Specialists Center, LLC
Chicago Ridge, Illinois, 60415
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
The Ohio State University College of Optometry
Columbus, Ohio, 43210-1280
Concord Ophthalmologic Associates
Concord, New Hampshire, 03301
Midwestern U Chicago College of Optometry
Downers Grove, Illinois, 60515
Duke University Eye Center
Durham, North Carolina, 27710
Nova Southeastern University College of Optometry, The Eye Institute
Fort Lauderdale, Florida, 33382
Marshall B. Ketchum University
Fullerton, California, 92831
University of Florida Shands Hospital
Gainesville, Florida, 32608
Midwestern University Eye Institute
Glendale, Arizona, 85308
Helen DeVos Children's Hospital Pediatric Ophthalmology
Grand Rapids, Michigan, 49503
Pediatric Ophthalmology, P.C.
Grand Rapids, Michigan, 49546
Texas Children's Hospital - Dept. Of Ophthalmology
Houston, Texas, 77030
University of Houston College of Optometry
Houston, Texas, 77204
Riley Hospital for Children
Indianapolis, Indiana, 46202
Nemours Children's Clinic
Jacksonville, Florida, 32207
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
Gundersen Health System
La Crosse, Wisconsin, 54601
Conestoga Eye
Lancaster, Pennsylvania, 17601
University of Kentucky Department of Neurology
Lexington, Kentucky, 40536
Arkansas Childrens
Little Rock, Arkansas, 72202
Loma Linda University Health Care, Dept. of Ophthalmology
Loma Linda, California, 92354
Texas Tech University Health Science Center
Lubbock, Texas, 79430
Southern College of Optometry
Memphis, Tennessee, 38104
University of Minnesota
Minneapolis, Minnesota, 55454
Saddleback Eye Medical Associates
Mission Viejo, California, 92691
The Eye Specialist Center, LLC
Munster, Indiana, 46321
State University of New York, College of Optometry
New York, New York, 10036
Virginia Pediatric Eye Center
Norfolk, Virginia, 23502
Dean A. McGee Eye Institute, University of Oklahoma
Oklahoma City, Oklahoma, 73104
University of Nebraska Medical Center
Omaha, Nebraska, 68114
Stanford University
Palo Alto, California, 94303
Salus University/Pennsylvania College of Optometry
Philadelphia, Pennsylvania, 19141
UPMC Children's Eye Center of Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Eye Care Associates, Inc.
Poland, Ohio, 44514
Western University College of Optometry
Pomona, California, 91766
Pacific University College of Optometry
Portland, Oregon, 97205
Casey Eye Institute
Portland, Oregon, 97239
Mayo Clinic Department of Ophthalmology
Rochester, Minnesota, 55905
University of California San Francisco Department of Ophthalmology
San Francisco, California, 94143
U of MO St. Louis College of Optometry
St Louis, Missouri, 63121
Houston Eye Associates
The Woodlands, Texas, 77381
Children's Eye Care PC
West Bloomfield, Michigan, 48322
Wolfe Eye Clinic
West Des Moines, Iowa, 50266
Pediatric Eye Associates
Wilmette, Illinois, 60091
Canada2 sites
Alberta Children's Hospital
Calgary, Alberta
CHU - Sainte-Justine
Montreal, Quebec, H3T 1C5
About this study
Official title: A Randomized Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia
The main objectives of this randomized trial comparing overminus lens treatment to non-overminus (spectacles without overminus or spectacles with plano lenses) are to determine:
- The long-term on-treatment effect of overminus treatment on distance intermittent exotropia (IXT) control score.
- The off-treatment effect of overminus treatment on distance IXT control score (following weaning and 3 months off treatment).
Read the detailed description
The main objectives of this randomized trial comparing overminus lens treatment to non-overminus (spectacles without overminus or spectacles with plano lenses) are to determine:
- The long-term on-treatment effect of overminus treatment on distance IXT control score.
- The off-treatment effect of overminus treatment on distance IXT control score (following weaning and 3 months off treatment).
The recently completed IXT3 pilot study (NCT02223650) addressed the question of whether overminus lens therapy has an initial short-term therapeutic effect for IXT while wearing overminus spectacles. There have been no rigorous studies that address the following important questions related to overminus lens therapy:
- Does overminus lens therapy have a long-term therapeutic effect for IXT while wearing overminus spectacles (over many months or years)?
- Does overminus lens therapy have a long-term therapeutic effect for IXT when overminus spectacles are discontinued?
In November 2019, a protocol amendment discontinued overminus lens treatment and extended the study for an additional 18 months after the 18-month randomized trial has ended. The objective of the extension study is to compare long-term refractive error between subjects originally treated with either overminus spectacles or non-overminus spectacles as part of the 18-month randomized trial; treatment is at investigator discretion.
- 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
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Non-overminus treatmentDevice
spectacles with full cycloplegic refraction without overminus
| Study group | Role | What they receive |
|---|---|---|
| Overminus Treatment | Experimental | spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere Receives: Device: Overminus treatment |
| Non-overminus Treatment | Active comparator | spectacles with full cycloplegic refraction without overminus Receives: Device: Non-overminus treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Distance Control at 12-Months (On-Treatment Visit)
A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50 diopters (D) overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 12 months. 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).
Measured: 12 months
Mean Distance Control at 18-Months (Off-Treatment Visit)
A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50D overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 18 months (after treatment discontinuation). 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).
Measured: 18 months
Primary Outcome Measure Stratified by Sex
NIH-required analysis. Primary outcome measure (stratified by sex):
A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50 diopters (D) overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 12 months. 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).
Measured: 12 months
Primary Outcome Measure Stratified by Race
NIH-required analysis. Primary outcome measure (stratified by race):
A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50 diopters (D) overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 12 months. 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).
Measured: 12 months
Primary Outcome Measure Stratified by Ethnicity
NIH-required analysis. Primary outcome measure (stratified by ethnicity):
A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50 diopters (D) overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 12 months. 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).
Measured: 12 months
Secondary outcomes (18)
Number of Participants With No Spontaneous Tropia
The number of subjects with no spontaneous tropia at 12 months and at 18 months will be compared between treatment groups.
Measured: 12 months
No Spontaneous Tropia
The proportion of subjects with no spontaneous tropia at 12 months and at 18 months will be compared between treatment groups.
Measured: At 18 months
Change in Distance Control
The proportion of subjects with ≥1 point improvement in distance control between baseline and 12 months will be compared between treatment groups. The proportion of subjects with ≥2 points improvement in distance control will be similarly compared between treatment groups. 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).
Measured: 12 months
Change in Distance Control
The proportion of subjects with ≥1 point improvement in distance control between baseline and 18 months will be compared between treatment groups. The proportion of subjects with ≥2 points improvement in distance control will be similarly compared between treatment groups. 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).
Measured: 18 months
Deterioration as Assessed by Motor Alignment and Stereoacuity at Near (12 Months)
The cumulative proportion of subjects who meet deterioration criteria by the time point will be estimated for each treatment group.
Participants who meet either of the following at any visit by a specific timepoint (e.g., 12 months, 18 months) will be considered to have met deterioration criteria by that timepoint.
- Motor deterioration: Control of the exodeviation measures 5 (constant exotropia) on all three assessments at distance and near. The exodeviation does not need to be constant throughout the entire exam provided that it is constant during all three assessments of control.
- Stereoacuity deterioration: Drop in near stereoacuity of at least 2 octaves from enrollment stereoacuity, or to nil, confirmed by a retest by a Masked Examiner on a subsequent day.
Note: participants with nil stereoacuity at enrollment will not be able to deteriorate with respect to a drop in near stereoacuity.
Measured: 12 months
Deterioration as Assessed by Motor Alignment and Stereoacuity at Near (18 Months)
The cumulative proportion of subjects who meet deterioration criteria by the time point will be estimated for each treatment group.
Participants who meet either of the following at any visit by a specific timepoint (e.g., 12 months, 18 months) will be considered to have met deterioration criteria by that timepoint.
- Motor deterioration: Control of the exodeviation measures 5 (constant exotropia) on all three assessments at distance and near. The exodeviation does not need to be constant throughout the entire exam provided that it is constant during all three assessments of control.
- Stereoacuity deterioration: Drop in near stereoacuity of at least 2 octaves from enrollment stereoacuity, or to nil, confirmed by a retest by a Masked Examiner on a subsequent day.
Note: participants with nil stereoacuity at enrollment will not be able to deteriorate with respect to a drop in near stereoacuity.
Measured: 18 months
Near Control (12 Months)
Mean control of the near exodeviation (average of 3 measurements over the exam). 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).
Measured: 12 months
Near Control (18 Months)
Mean control of the near exodeviation (average of 3 measurements over the exam). 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).
Measured: 18 months
Change in Near Control (12 Months)
For each timepoint, the change in near control since baseline will be reported. 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).
Measured: 12 months
Change in Near Control (18 Months)
For each timepoint, the change in near control since baseline will be reported. 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).
Measured: 18 months
Angle Magnitude (12 Months)
The magnitude of the deviation by Prism Alternate Cover Test (PACT) will be compared between treatment groups.
Measured: 12 months
Angle Magnitude (18 Months)
The magnitude of the deviation by Prism Alternate Cover Test (PACT) will be compared between treatment groups.
Measured: 18 months
Stereoacuity at 12 Months
A comparison of near stereoacuity will be assessed using the Randot Preschool stereotest at near (performed at 40 cm) between treatment groups.
Measured: 12 months
Stereoacuity at 18 Months
A comparison of near stereoacuity will be assessed using the Randot Preschool stereotest at near (performed at 40 cm) between treatment groups.
Measured: 18 months
Compliance With Spectacle Wear (12 Months)
Compliance with spectacle wear will be assessed at the 12-month and 18-month outcome exam. Parents will give an estimate of the proportion of the time their children wore their spectacles. Proportion of time worn will be described as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), or poor (≤ 25%). The distribution of compliance will be assessed for each treatment group at the outcome exam.
Measured: 12 months
Compliance With Spectacle Wear (18 Months)
Compliance with spectacle wear will be assessed at the 12-month and 18-month outcome exam. Parents will give an estimate of the proportion of the time their children wore their spectacles. Proportion of time worn will be described as excellent (76% to 100%), good (51% to 75%), fair (26% to 50%), or poor (≤ 25%). The distribution of compliance will be assessed for each treatment group at the outcome exam.
Measured: 18 months
Parent Symptom Survey [12 Months]
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.
Measured: At 12 months
Parent Symptom Survey [18 Months]
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.
Measured: At 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study start16 Jan 2017
- Primary completion30 Nov 2020
- Study completion15 Feb 2022
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 (3)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
- 386 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
- Angela M Chen, OD, MS, Study chair, Marshall B. Ketchum UniversityS. Ayse Erzurum, MD, Study chair, Eye Care Associates, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02807350
- Sponsor's protocol ID
- IXT5
- Other IDs
- 2U10EY011751
- Acronym
- IXT5
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2016
- Last updated
- 9 Jul 2026
- 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
Chen AM, Erzurum SA, Chandler DL, Hercinovic A, Melia BM, Bhatt AR, Suh DW, Vricella M, Erickson JW, Miller AM, Marsh JD, Bodack MI, Martinson SR, Titelbaum JR, Gray ME, Holtorf HL, Kong L, Kraker RT, Rahmani B, Shah BK, Holmes JM, Cotter SA; Pediatric Eye Disease Investigator Group. Overminus Lens Therapy for Children 3 to 10 Years of Age With Intermittent Exotropia: A Randomized Clinical Trial. JAMA Ophthalmol. 2021 Apr 1;139(4):464-476. doi: 10.1001/jamaophthalmol.2021.0082.
PubMed 33662112Writing Committee for the Pediatric Eye Disease Investigator Group; Pediatric Eye Disease Investigator Group; Chen AM, Erzurum SA, Chandler DL, Hercinovic A, Wu R, Vricella M, Waters AL, Ticho BH, Erickson JW, Han S, McDowell PS, Li Z, Kraker RT, Holmes JM, Cotter SA. Refractive Error Change and Overminus Lens Therapy for Childhood Intermittent Exotropia. JAMA Ophthalmol. 2024 May 1;142(5):417-428. doi: 10.1001/jamaophthalmol.2024.0276.
PubMed 38536764Holmes JM, Leske DA, Hercinovic A, Hatt SR, Chandler DL, Li Z, Melia BM, Chen AM, Erzurum SA, Crouch ER, Jenewein EC, Kraker RT, Cotter SA; Pediatric Eye Disease Investigator Group. Rasch-calibrated Intermittent Exotropia Symptom Questionnaire for Children. Optom Vis Sci. 2022 Jun 1;99(6):513-520. doi: 10.1097/OPX.0000000000001901. Epub 2022 Apr 12.
PubMed 35412528
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia
- ClinicalTrials.gov ID
- NCT02807350
- Acronym / sponsor ID
- IXT5 / IXT5
- Conditions
- Intermittent Exotropia
- Keywords
- Intermittent Exotropia, IXT, overminus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)
- Study start
- 16 Jan 2017 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 21 Jun 2016 (estimated)
- Results
- Posted 3 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objectives of this randomized trial comparing overminus lens treatment to non-overminus (spectacles without overminus or spectacles with plano lenses) are to determine:
- The long-term on-treatment effect of overminus treatment on distance intermittent exotropia (IXT) control score.
- The off-treatment effect of overminus treatment on distance IXT control score (following weaning and 3 months off treatment).
Detailed description
The main objectives of this randomized trial comparing overminus lens treatment to non-overminus (spectacles without overminus or spectacles with plano lenses) are to determine:
- The long-term on-treatment effect of overminus treatment on distance IXT control score.
- The off-treatment effect of overminus treatment on distance IXT control score (following weaning and 3 months off treatment).
The recently completed IXT3 pilot study (NCT02223650) addressed the question of whether overminus lens therapy has an initial short-term therapeutic effect for IXT while wearing overminus spectacles. There have been no rigorous studies that address the following important questions related to overminus lens therapy:
- Does overminus lens therapy have a long-term therapeutic effect for IXT while wearing overminus spectacles (over many months or years)?
- Does overminus lens therapy have a long-term therapeutic effect for IXT when overminus spectacles are discontinued?
In November 2019, a protocol amendment discontinued overminus lens treatment and extended the study for an additional 18 months after the 18-month randomized trial has ended. The objective of the extension study is to compare long-term refractive error between subjects originally treated with either overminus spectacles or non-overminus spectacles as part of the 18-month randomized trial; treatment is at investigator discretion.
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 treatmentspectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere |
| Non-overminus Treatment | Active comparator | Device: Non-overminus treatmentspectacles with full cycloplegic refraction without overminus |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (24 listed)
- Age 3 years to < 11 years
- Intermittent exotropia (manifest deviation) meeting all of the following criteria:
- At distance: intermittent exotropia or constant exotropia
- o Mean distance control score of 2 points or more (mean of 3 assessments over the exam)
- At near: intermittent exotropia, exophoria, or orthophoria
Key exclusion criteria (9 listed)
- Treatment for IXT or amblyopia (other than refractive correction) within the past 4 weeks, including vision therapy, patching, atropine, or other penalization.
- Current contact lens wear
- Substantial deliberate overminus treatment within the past 6 months, defined as spectacles overminused by more than 1.00D SE than the cycloplegic refractive error (within 2 months or at the end of the enrollment exam)
- Prior strabismus, intraocular, or refractive surgery (including BOTOX injection)
- Abnormality of the cornea, lens, or central retina
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 therapyspectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere | Device | Overminus Treatment |
| Non-overminus treatmentspectacles with full cycloplegic refraction without overminus | Device | Non-overminus Treatment |
Primary outcome
Mean Distance Control at 12-Months (On-Treatment Visit)
Time frame: 12 months
A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50 diopters (D) overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 12 months. 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).
Mean Distance Control at 18-Months (Off-Treatment Visit)
Time frame: 18 months
A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50D overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 18 months (after treatment discontinuation). 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
Time frame: 12 months
NIH-required analysis. Primary outcome measure (stratified by sex): A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50 diopters (D) overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 12 months. 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
Time frame: 12 months
NIH-required analysis. Primary outcome measure (stratified by race): A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50 diopters (D) overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 12 months. 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
Time frame: 12 months
NIH-required analysis. Primary outcome measure (stratified by ethnicity): A comparison of mean control of the distance exodeviation (average of 3 measurements over the exam) between the 2.50 diopters (D) overminus group and the non-overminus group (spectacles without overminus or no spectacles) at 12 months. 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).
18 secondary outcomes
Number of Participants With No Spontaneous Tropia
Time frame: 12 months
No Spontaneous Tropia
Time frame: At 18 months
Change in Distance Control
Time frame: 12 months
Change in Distance Control
Time frame: 18 months
Deterioration as Assessed by Motor Alignment and Stereoacuity at Near (12 Months)
Time frame: 12 months
Deterioration as Assessed by Motor Alignment and Stereoacuity at Near (18 Months)
Time frame: 18 months
Near Control (12 Months)
Time frame: 12 months
Near Control (18 Months)
Time frame: 18 months
Change in Near Control (12 Months)
Time frame: 12 months
Change in Near Control (18 Months)
Time frame: 18 months
Angle Magnitude (12 Months)
Time frame: 12 months
Angle Magnitude (18 Months)
Time frame: 18 months
Stereoacuity at 12 Months
Time frame: 12 months
Stereoacuity at 18 Months
Time frame: 18 months
Compliance With Spectacle Wear (12 Months)
Time frame: 12 months
Compliance With Spectacle Wear (18 Months)
Time frame: 18 months
Parent Symptom Survey [12 Months]
Time frame: At 12 months
Parent Symptom Survey [18 Months]
Time frame: At 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33662112Chen AM, Erzurum SA, Chandler DL, Hercinovic A, Melia BM, Bhatt AR, Suh DW, Vricella M, Erickson JW, Miller AM, Marsh JD, Bodack MI, Martinson SR, Titelbaum JR, Gray ME, Holtorf HL, Kong L, Kraker RT, Rahmani B, Shah BK, Holmes JM, Cotter SA; Pediatric Eye Disease Investigator Group. Overminus Lens Therapy for Children 3 to 10 Years of Age With Intermittent Exotropia: A Randomized Clinical Trial. JAMA Ophthalmol. 2021 Apr 1;139(4):464-476. doi: 10.1001/jamaophthalmol.2021.0082.
- Derived from this study: PubMed 38536764Writing Committee for the Pediatric Eye Disease Investigator Group; Pediatric Eye Disease Investigator Group; Chen AM, Erzurum SA, Chandler DL, Hercinovic A, Wu R, Vricella M, Waters AL, Ticho BH, Erickson JW, Han S, McDowell PS, Li Z, Kraker RT, Holmes JM, Cotter SA. Refractive Error Change and Overminus Lens Therapy for Childhood Intermittent Exotropia. JAMA Ophthalmol. 2024 May 1;142(5):417-428. doi: 10.1001/jamaophthalmol.2024.0276.
- Derived from this study: PubMed 35412528Holmes JM, Leske DA, Hercinovic A, Hatt SR, Chandler DL, Li Z, Melia BM, Chen AM, Erzurum SA, Crouch ER, Jenewein EC, Kraker RT, Cotter SA; Pediatric Eye Disease Investigator Group. Rasch-calibrated Intermittent Exotropia Symptom Questionnaire for Children. Optom Vis Sci. 2022 Jun 1;99(6):513-520. doi: 10.1097/OPX.0000000000001901. Epub 2022 Apr 12.
- 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.
Angela M Chen, OD, MS study chair
Marshall B. Ketchum University
S. Ayse Erzurum, MD study chair
Eye Care Associates, Inc.
61 sites in 2 countries: 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 61 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 9 exclusion criteria. 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 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 61 sites in United States, Canada. 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 3 Jun 2022). 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 Control at 12-Months (On-Treatment Visit) (time frame: 12 months). The study lists 5 primary outcomes in all. 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 NCT02807350, which also lists 3 linked publications.
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 9 Jul 2026.