Trial of Overminus Spectacle Therapy for Intermittent Exotropia



Status:Active, not recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:3 - 10
Updated:4/5/2019
Start Date:January 16, 2017
End Date:July 1, 2020

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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).

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?

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)]
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Mission Viejo, California 92691
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1 Perkins Square
Akron, Ohio 44308
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Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
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1720 2nd Ave S
Birmingham, Alabama 35233
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800 Washington St
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Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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4901 Calhoun Road
Houston, Texas 77204
Phone: 713-743-1944
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807 Childrens Way
Jacksonville, Florida 32207
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Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
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Minneapolis, Minnesota 55455
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5460 La Palma Avenue
Anaheim, California 92807
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Atlanta, Georgia 30322
Phone: 404-778-4725
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Baltimore, Maryland
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6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
Phone: 443-849-8082
Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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Bloomington, Indiana 47405
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190 East Bannock Street
Boise, Idaho 83712
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Boston, Massachusetts 02118
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Calgary, Alberta
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Charleston, South Carolina 29425
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1949 Gunbarrel Road
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225 E Chicago Ave
Chicago, Illinois 60611
(312) 227-4000
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Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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Chicago, Illinois 60616
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10436 Southwest Highway
Chicago Ridge, Illinois 60415
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Cincinnati, Ohio 45229
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Columbus, Ohio 43210
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248 Pleasant Street
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Downers Grove, Illinois 60515
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Fort Lauderdale, Florida 33382
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Fullerton, California 92831
Principal Investigator: Angela Chen, O.D., M.S.
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Gainesville, Florida 32608
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705 Riley Hospital Dr
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Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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Kansas City, Missouri 64108
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Lancaster, Pennsylvania 17601
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Memphis, Tennessee 38104
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
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Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Palo Alto, California 94304
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1200 West Godfrey Avenue
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Poland, Ohio 44514
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309 East 2nd Street
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Portland, Oregon 97205
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Rochester, Minnesota 55905
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Saint Louis, Missouri 63121
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