Current Pediatric Ophthalmology Trials

Two-Year Follow Up after Treatment of Severe Retinopathy of Prematurity with Low-Dose Bevacizumab
PI: Amy Hutchinson, MD
Coordinator: Judy Brower, COMT
Status: Enrolling

General Summary:
This study enrolls only those subjects that have participated in Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity. It consists of an eye exam and developmental testing at about 24 months of age.

Clinical Summary:
Subjects enrolled in Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity have their final study exam at about 12 months of age. The Two-Year Follow Up after Treatment of Severe Retinopathy of Prematurity with Low-Dose Bevacizumab trial seeks to enroll these subjects in order to evaluate long term outcomes by conducting an eye exam and developmental testing at age 24 months.

Inclusion Criteria:
Must have been enrolled in the Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity clinical trial.

Contact Name: Judy Brower
Contact Phone Number: (404) 778-4725; email:
Posted: 07-02-2018


Myopia Treatment Study 1 (MTS1)
Low-Dose Atropine for Treatment of Myopia

PI: Natalie Weil, MD
Coordinator: Linda Curtis
Status: Enrolling

General Summary:
The objectives for this randomized trial are:
1.To determine the efficacy of daily low-dose atropine (0.01%) for slowing myopia progression over a two-year treatment period in children aged 5 to less than 13 years with myopia -1.00 to -6.00D at the time of enrollment (Primary Outcome On-Treatment).
2.To determine the efficacy of atropine treatment on myopia progression 6 months following cessation of low-dose atropine treatment (Secondary Outcome Off-Treatment).

Clinical Summary:
The current study is designed as an efficacy study, making effort to maximize adherence to treatment group assignments. After a run-in phase during which all participants are treated with daily artificial tear eyedrops for 2-4 weeks (and glasses are updated if required) to assess their ability to adhere to daily eye drops, participants are randomly assigned to daily atropine or placebo for 24 months, followed by 6 months off treatment.

Inclusion Criteria:
To take part in this study, the child must be or have the following:
• be 5 to younger than 13 years of age
• have near-sightedness (myopia)
• never have had atropine eye drops to treat myopia
• never have worn bifocals
• never worn special types of contact lenses used to slow myopia development
• have no allergy to atropine
• refractive error meeting the following by cycloplegic autorefraction:
  ‡ Myopia -1.00D to -6.00D spherical equivalent (SE) in both eyes
  ‡ Astigmatism <=1.50D in both eyes
  ‡ Anisometropia <1.00D SE
• Gestational age ≥ 32 weeks.
• Birth weight >1500g.
• Parent understands the protocol and is willing to accept randomization to atropine or placebo.
• Is willing to participate in a 2 to 4 week run-in phase using daily artificial tear eyedrops.
• Able to return in 2 to 4 weeks for possible randomization.
• Parent has a phone (or access to phone) and is willing to be contacted by Investigator's site staff.
• Relocation outside of the area of an active PEDIG site within next 32 months is not anticipated.

Exclusion Criteria:
• Current or previous myopia treatment with atropine, pirenzepine or other anti-muscarinic agent.
• Current or previous use of bifocals, progressive-addition lenses, or multi-focal contact lenses.
• Current or previous use of orthoK, rigid gas permeable, or other contact lenses being used to reduce myopia progression.
• Known atropine allergy.
• Abnormality of the cornea, lens, central retina, iris or ciliary body.
• Current or prior history of manifest strabismus, amblyopia, or nystagmus.
• Prior eyelid, strabismus, intraocular, or refractive surgery.
• Down syndrome or cerebral palsy.
• Females who are pregnant, lactating, or intending to become pregnant within the next 30 months.
  ‡ A negative urine pregnancy test will be required for all females who have experienced menarche.

Contact: Linda Curtis; (404) 778-4261;
Posted: 01-23-2018

Infant Aphakia Treatment Study (IATS): Phase 3
PI: Scott Lambert, MD, National Study Chairman, (Former Emory Site Investigator_;  Carolyn D. Drews-Botsch, PhD, MPH:  (Current Emory Site Investigator)
Coordinators: Marla Shainberg, CO (Site); Lindy DuBois , MEd, MMSc, CO, COMT (former National Coordinator)
Status: Closed to enrollment;  patients in follow-up

General Summary:
Comparison of the cumulative incidence of glaucoma between the two treatment groups ( primarily implanted intraocular lens vs contact lens for patients treated at 1 to 6 months of age for unilateral congenital cataract in IATS Phases 1 and 2)at age 10 years to determine which initial treatment is associated with the lowest long-term risk of glaucoma or glaucoma suspect;  characterization of  myopic shift between the ages of 5 and 10 years in the IOL group;  examination of the impact of unilateral congenital cataract on reading (speed, accuracy and comprehension), self-esteem and Health Related Quality of Life.

Inclusion Criteria:
• Age 10 yo
• Enrolled in Infantile Aphakia Treatment Study: Phase 1 with visually significant unilateral cataract at age 28-210 days at the time of cataract extraction surgery and randomized to treatment group of either an intraocular lens implanted at the time of surgery or a contact lens.

Exclusion Criteria:
• Patient born at less than 36 gestational weeks.
• Cataract is acquired from trauma or as a treatment side effect.
• Patient has had intraocular surgery or has significant ocular disease that may affect vision.
• Patient has a condition that would interfere with vision testing.

Contact: Marla Shainberg, CO 404-778-2928
Sponsor: NIH/NEI
Posted: 01-23-2018

An Observational, Multicenter Study of the Prevalence of Cerebrotendinous Xanthomatosis (CTX) in Patient Populations Diagnosed with Early-Onset Idiopathic Bilateral Cataracts
PI: Scott Lambert, MD; Phoebe Lenhart, MD
Coordinator: Judy Brower
Status: Enrolling

General Summary:
This study is not a treatment study. It consists of one blood draw and urine collection, if possible. The purpose is to determine the prevalence of CTX in patients that have had cataracts in both eyes that were diagnosed between the ages of 2 and 21 years of age. Subjects must be at least 2 years of age to participate but there is no upper age limit for participation.

Blood and urine (if collected) are sent to a central lab for testing. If the blood shows high levels of plasma cholestanol or the urine is positive for urine bile alcohol, genetic testing for CTX will be done at the lab using the sample they have. Results will be reported to the investigator and the patient will be notified of the results.

Clinical Summary:
CTX is a rare disease in which a wide variety of symptoms appear any time from birth through adulthood and worsen over time. Symptoms most often include chronic diarrhea beginning as an infant, developmental delay, behavioral disorders, cataracts in both eyes of children, brittle bones that are prone to fracture, neurolological problems (such as dementia, seizures, depression, hallucinations), movement and speech problems.

Treatment does exist for the condition, but it is not part of the study.

Inclusion Criteria:
• The patient has or has had a diagnosis of idiopathic (unknown cause)cataracts in both eyes.
• The patient is/was between the ages of 2 to 21 years old at the time of cataract diagnosis.

Exclusion Criteria:
• Patient has a diagnosis of cataracts with known etiology other than CTX.
• Patient has a diagnosis of CTX.
• Patient has cataracts caused by medication or other treatment.
• Patient has taken or currently taking cholic acid or chenodeoxycholic acid.
• Patient has received an investigational product in the past 30 days.

Contact: Judy Brower, (404) 778-4725;
Posted: 01-19-2018

Binocular Dig Rush Game Treatment for Amblyopia (ATS20)
Jason Peragallo, MD
Job Title:
Principal Investigator
Judy Brower; Obinna Uzoho, CO

General Summary:
This study is to compare results of 1 hour per day binocular game play 5 days each week, wearing correct glasses if needed, with wearing correct glasses only for treatment of amblyopia in children 4 years of age to less than 13 years of age. Eligible children will be randomly assigned to one of two groups:

1. Binocular treatment group: Binocular computer game play (wearing correct glasses) for 1 hour each day, 5 days a week (may split into shorter sessions totaling 1 hour)
2. Continue wearing correct glasses, if glasses are needed

Patients in the computer game group will be given an iPad with the game on it which will be returned during the 8 week exam. If a patient is randomized to glasses only and at the end of 8 weeks still remains amblyopic, they will be offered the iPad with the game to play for 8 weeks, then must return at the 16 week visit for an eye exam and to return the iPad.

The computer game is played with a special glasses (over glasses, if glasses have been prescribed).

Clinical Summary:
Study patients will be examined at enrollment, week 4, and week 8. Those initially assigned to glasses only who choose to play the game at the 8 week visit will return at 16 weeks to have their visual acuity checked and to return the iPad.

Red/Green glasses are worn during game play. The contrast of images seen by the amblyopic eye (through the green filter) will be at 100%. The contrast of images seen by the fellow eye (through the red filter) will begin at 20% and will increase or decrease automatically based on game performance and duration of game play.

Some images are seen only through the red lens while others are seen only through the green lens. The contrast (brightness) of the images in the game will vary depending on the severity of the amblyopia.

Inclusion Criteria:
• Age 4 to less than 13 years
• No amblyopia treatment other than optical correction in the past 2 weeks
• Current glasses based on cycloplegic refraction within last 7 months
• Correct glasses must have been worn for at least 16 weeks OR vision stable on 2 consecutive exams at least 8 weeks apart
• Visual acuity on research machine must be within a certain range
• If heterotropia exists, near deviation must be less than or equal to 5 prism diopters
• Must be able to play the Dig Rush game while wearing the special glasses (over current glasses, if applicable)

Exclusion Criteria:
• Patient has telephone and is willing to be contacted by the study staff
• Prism in glasses (may participate if prism discontinued at least 2 weeks before enrollment
• Myopia greater than -6.00 spherical equivalent in either eye
• Previous intraocular or refractive surgery
• Any treatment for amblyopia (including patching, atropine, Bangerter filter, vision therapy or previous binocular treatment) during past 2 weeks before enrollment
• No Down Syndrome or cerebral palsy
• No severe development delay that would interfere with treatment or evaluation (in opinion of investigator). Mild speech delay or reading and/or learning disabilities are not excluded.

Contact Name: Judy Brower, (404) 778-4725,
Posted/Updated: 03/21/2017; 01/19/2018

A Randomized Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia (IXT5)
PI: Jason Peragallo, MD
Coordinator: Judy Brower; Obinna Uzoho, CO
Status: Enrolling

General Summary: A previous short term overminus study demonstrated that overminus glasses helped children control their exotropia compared with children who were not overminused in their glasses. This current study will study the long-term effect of overminus glasses as well as the effect after weaning off of this treatment.

Inclusion Criteria:
• 3 years to less than 11 years of age
• Intermittent exotropia
• Refractive error between -6.00 spherical equivalent and +1.00 spherical equivalent
• Cycloplegic refraction performed within the past 2 months
• If glasses needed, then the current prescription must have been worn for at least 1 week before enrollment
• Gestational age greater than or equal to 32 weeks
• Birthweight greater than 1500 grams
• Parent willing to accept treatment assignment of overminus glasses or non-overminus glasses
• Parent has access to phone and willing to be contacted by Jaeb Center

Exclusion Criteria:
• No treatment for exotropia other than glasses within 4 weeks from enrollment (includes vision therapy, patching, atropine)
• Current contact lens wear
• Substantial overminus treatment within the past 6 months
• Past eye surgery (including BOTOX injection)
• Severe developmental delay
• Multiple Sclerosis, Graves orbitopathy, or any disease known to affect ocular motility or accommodation
• Anti-seizure medications

Contact Name: Judy Brower, (404) 778-4725,
Posted/Updated: 1/05/2017; 01/19/2018

Pediatric Optic Neuritis Prospective Outcomes Study
Jason Peragallo, MD
Coordinator: Judy Brower
Status: Enrolling

General Summary: This is not a treatment study. This is to determine whether enough subjects in this age group with optic neuritis can be enrolled into a clinical trial. The study will look at visual acuity at certain time points after the diagnosis of pediatric optic neuritis is confirmed. It will help to estimate the risk of developing optic neuritis in the fellow eye within 2 years after enrollment (if initially present in one eye). It will also help to estimate the risk of developing multiple sclerosis 2 years after enrollment.

Clinical Summary:
Treatment is standard of care for this condition. Visits will be Enrollment, 1 month, 6 months, 1 year, and 2 years. More visits may be required if needed for standard of care. Visual acuity will be checked by a different method that is typically used here. There are some questionnaires that will be administered as part of the study.

Inclusion Criteria:

• 3 to less than 16 years of age.
• Optic neuritis in at least one eye.
• Visual loss and/or pain with eye movements for 2 weeks or less.
• There are certain eye exam findings that must be met.
• MRI of the orbits must have been done with certain findings OR will be done in the next 2 weeks as standard of care (not part of the study).

Exclusion Criteria:
• Planning to move out of the area within the next 2 years and follow up at another study center is not possible.
• Previous episode of optic neuritis in the same eye.
• Lab findings that suggest a condition other then optic neuritis.
• A condition in the affected eye(s) that might affect visual acuity.

Contact Name: Judy Brower, (404) 778-4725,
Posted/Updated: 12/01/2016; 03/21/2017

A Prospective Observational Study of Adult Strabismus
PI: Jason Peragallo, MD
Coordinator: Judy Brower
Status: Enrollment closed

General Summary:
This study is looking at 3 common causes and treatments of new onset adult strabismus (Misalignment of the eyes). This observational study will help to describe clinical characteristics, treatments, and one year outcomes of the following conditions: Convergence Insufficiency, Divergence Insufficiency, and Small Angle Hypertropia. Testing at study visits will include visual acuity, ocular alignment (measuring how much an eye turns in, out, or up), how well the eyes can work together, and questionnaires. The protocol does not dictate the treatment, the physician will treat as standard of care.

Inclusion Criteria:
• All patients must be 18 years or older.
• Visual acuity 20/50 or better in each eye.
• Physician feels that condition is ready to treat.
• Recommended treatment has not been used within the past year.
• Physician ready to treat with prisms, orthoptic exercises, botulinum, or surgery.

In addition to the criteria above, each condition has additional criteria:

If condition is Convergence Insufficiency:
• No eye muscle surgery in past 10 years.
• No constant exotropia at distance or near.

If condition is Divergence Insufficiency:
• No eye muscle surgery in the past.
• Double vision in the distance.

If condition is Hypertropia:
• No eye muscle surgery in the past.
• Double vision at distance or near.

Exclusion Criteria:
• Paralytic, paretic, or restrictive eye muscle problems.
• Double vision in one eye only.
• Thyroid Eye Disease, Myasthenia Gravis, chronic progressive external ophthalmoplegia, or eye movement problems caused by neurological disease (Parkinson’s may be ok).

Contact: Judy Brower, COMT, 404-778-4725
Posted/Updated: 08/24/2015; 11/30/2016; 01/19/2018

Pediatric Ophthalmology: Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity
Amy Hutchinson, MD
Judy Brower, COMT, 404-778-4725

General Summary:
The purpose of this study is to determine a lower dose of Bevacizumab currently used for severe Retinopathy of Prematurity that is effective and can be tested in larger studies in the future.

Clinical Summary:
In-patient premature infants will be enrolled and will receive a single intraocular injection of Bevacizumab at a dose lower than usually given determined by the protocol. If the eye does not show improvement additional standard of care treatment may be given. Exams will be performed the day after treatment, weekly for 4 weeks, and more often if needed.

There will be one follow up visit in the clinic at one year (gestational age). There is an optional blood draw before treatment, 2 and 4 weeks after treatment to help determine amounts of VEGF and Avastin.

Inclusion Criteria:
• Type 1 Retinopathy of Prematurity
• No previous treatment for Retinopathy of Prematurity in the study eye and no previous Bevacizumab in the non-study eye.

Exclusion Criteria:
• Nasal lacrimal duct obstruction
• Major ocular anomalies
• Any opacity that prevents an adequate view of the retina
• Purulent ocular discharge in either eye

Contact: Judy Brower, COMT, 404-778-4725
Posted/Updated: 06/08/2015, 08/24/2015; 11/30/2016; 03/21/2017

Pediatric Cataract Surgery Outcomes Registry
PI: Scott Lambert, MD; Phoebe Lenhart, MD
Coordinator: Judy Brower, COMT; Marla Shainberg, CO
Status: Closed to Enrollment

GeneralSummary: A national registry is being formed to collect information about cataract surgery performed on children less than 13 years of age. Within 45 days after surgery, parent will be asked if they would like to enroll their child. This registry is for data collection only, there are no study visits or study procedures. The only study test performed is the visual acuity at 5 years. Each year for 5 years the patient record will be reviewed and information collected. Some common complications for cataract surgery in children include clouding of the capsule requiring laser treatment, retinal detachment, amblyopia (decreased vision in that eye), glaucoma, unequal vision in the two eyes.

The incidence, risk factors, and natural history of these events that affect vision have not been studied in a large group.

Inclusion Criteria:
– Less than 13 at time of surgery

Exclusion Criteria:
– Follow-up at the study center not possible

Contact: Judy Brower, COMT, 404-778-4725
Posted/Updated: 07-31-2012; 01-18-2013; 07-03-2013; 06/08/2015; 03/21/2017

Intermittent Exotropia Study 1 (IXT1): A Randomized Trial of Bilateral Lateral Rectus Recession versus Unilateral Lateral Rectus Recession with Medial Rectus Resection of Intermittent Exotropia (PEDIG)

PI: Scott Lambert, MD; Amy Hutchinson, MD
Coordinator: Judy Brower, COMT; Marla Shainberg, CO
Status: Enrollment closed.

General Summary: To determine whether one of two commonly used surgical procedures is better than the other for intermittent exotropia. Both procedures require two eye muscles to be operated on - one procedure is to operate on two muscles in one eye; the other is to operate on one muscle in each eye.

Clinical Summary: To compare bilateral lateral rectus recession to unilateral lateral rectus recession with medial rectus resection for intermittent exotropia.

Inclusion Criteria:
- Age 3 < 11 years
- Intermittent exotropia at distance OR constant exotropia at distance and intermittent exotropia or exophoria at near
- Birth weight at least 3 pounds, 5 ounces (1500 gm)
- Parents must be willing to accept either surgical procedure

Exclusion Criteria:
- Vertical deviation requiring surgery
- Previous eye muscle surgery
- Significant neurological impairment such as cerebral palsy
- Visual acuity difference of more than 2 lines and/or amblyopia treatment needed at this time.

Contact: Judy Brower, COMT, 404-778-4725
Date Posted: 02-29-2012; 03-12-2014; 03/21/2017

Glasses Versus Observation For Moderate Hyperopia in Young Children; HTS1 (PEDIG)

PI: Scott Lambert, MD; Amy Hutchinson, MD
Coordinator: Judy Brower, COMT
Status: Enrollment closed.

General Summary: This study is to determine whether moderately farsighted children benefit from glasses being prescribed at a young age.

Clinical Summary: Half of the children in this study will be prescribed glasses at the enrollment visit, the other half will be prescribed glasses only if it appears their vision, eye muscle alignment, or depth perception begins to deteriorate. Study visits are every 6 months for 3 years.

Inclusion Criteria:
- Age 1 yr to less than 5 years
- Moderately farsighted
- Parents willing to accept either group assignment

Exclusion Criteria:
- Any eye muscle imbalance
- Previously documented eye muscle imbalance
- Previous glasses or contact lenses
- Previous eye surgery
- Amblyopia treatment
- Previous eye muscle exercises
- Inability to test visual acuity if 3 yrs old or older

Contact: Judy Brower, COMT, 404-778-4725
Posted/Updates:: 02-29-2012; 01-18-2013; 10-24-2014



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