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Trial record 4 of 12 for:    "Pediatric Eye Disease Investigator Group" [Exact]

Trial of Overminus Spectacle Therapy for Intermittent Exotropia (IXT5)

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ClinicalTrials.gov Identifier: NCT02807350
Recruitment Status : Active, not recruiting
First Posted : June 21, 2016
Last Update Posted : March 1, 2019
Sponsor:
Collaborators:
Pediatric Eye Disease Investigator Group
National Eye Institute (NEI)
Information provided by (Responsible Party):
Jaeb Center for Health Research

Brief 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.
  • The off-treatment effect of overminus treatment on distance IXT control score (following weaning and 3 months off treatment).

Condition or disease Intervention/treatment Phase
Intermittent Exotropia Device: Overminus treatment Device: Non-overminus treatment Not Applicable

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?

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 386 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia
Actual Study Start Date : January 16, 2017
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : July 1, 2020


Arm Intervention/treatment
Experimental: Overminus Treatment
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Device: Overminus treatment
spectacles with full cycloplegic refraction plus 2.50 D overminus added to the sphere
Other Names:
  • Overminus spectacles
  • Overminus glasses
  • Overminus therapy

Active Comparator: Non-overminus Treatment
spectacles with full cycloplegic refraction without overminus
Device: Non-overminus treatment
spectacles with full cycloplegic refraction without overminus




Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. No Spontaneous Tropia [ Time Frame: At 12 months and 18 months ]
    The proportion of subjects with no spontaneous tropia at 12 months and at 18 months will be compared between treatment groups.

  2. Change in Distance Control [ Time Frame: At 12 months and 18 months ]
    The proportion of subjects with ≥1 point improvement in distance control between baseline and 12 months and 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.

  3. Deterioration as assessed by motor alignment and stereoacuity at near [ Time Frame: At 12 months and 18 months ]
    The cumulative proportion of subjects who meet deterioration criteria by the time point will be estimated for each treatment group.

  4. Near Control [ Time Frame: At 12 months and 18 months ]
    A comparison of mean control of the near 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 each timepoint.

  5. Change in Near Control [ Time Frame: At 12 months and 18 months ]
    For each timepoint, the proportion of subjects with ≥1 point improvement in near control since baseline will be compared between treatment groups. The proportion of subjects with ≥2 points improvement in near control will be similarly compared.

  6. Angle magnitude [ Time Frame: At 12 months and 18 months ]
    The magnitude of the deviation by Prism Alternate Cover Test (PACT) will be compared between treatment groups.

  7. Stereoacuity [ Time Frame: At 12 months and 18 months ]
    A comparison of near stereoacuity will be assessed using the Randot Preschool stereotest at near (performed at 40 cm) between treatment groups.

  8. Compliance with Spectacle Wear [ Time Frame: At 6 months and 12 months ]
    Compliance with spectacle wear will be assessed at the 6-month and 12-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.

  9. Symptom survey [ Time Frame: At 12 months and 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.



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Ages Eligible for Study:   3 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

  • 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

Exclusion Criteria:

  • 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
  • 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)]

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02807350


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Sponsors and Collaborators
Jaeb Center for Health Research
Pediatric Eye Disease Investigator Group
National Eye Institute (NEI)
Investigators
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Study Chair: Angela M Chen, OD, MS Marshall B. Ketchum University
Study Chair: S. Ayse Erzurum, MD Eye Care Associates, Inc.

Additional Information:
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Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT02807350     History of Changes
Other Study ID Numbers: IXT5
2U10EY011751 ( U.S. NIH Grant/Contract )
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Time Frame: Data will be made available after publication of each primary manuscript.
Access Criteria: Users accessing the data must enter an email address.

Keywords provided by Jaeb Center for Health Research:
Intermittent Exotropia
IXT
overminus

Additional relevant MeSH terms:
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Exotropia
Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs