Closed Pediatric Ophthalmology Trials

Binocular Computer Activities for Treatment of Amblyopia (ATS18)
PI: Scott Lambert, MD; Amy Hutchinson, MD
Coordinator: Judy Brower, COMT; Marla Shainberg, CO
Status: Completed.

GGeneral Summary: To determine how binocular computer games compare with patching for amblyopia in children 5 to less than 17 years old. Must be able to accept either treatment group: Play a computer game on the iPad for 1 hour each day for 16 weeks; or patch the stronger eye 2 hours each day for 16 weeks. Office visits every 4 weeks are required.

Inclusion Criteria: 
- Ages 5 < 17 years Amblyopia associated with strabismus, anisometropia, or both
- No amblyopia treatment in past 2 weeks 
- Cycloplegic refraction within past 7 months
- Wearing correct glasses 
- Ability to play computer game (Tetris)

Exclusion Criteria: 
- Prism in glasses 
- Myopia greater than -6.00 spherical equivalent 
- Previous intraocular or refractive surgery
- Treatment for amblyopia in the past 2 weeks 
- Down Syndrome or Cerebral Palsy 
- Strabismus greater than 10 diopters

Contact: Judy Brower, 404-778-4725; Marla Shainberg, 404-778-2928
Posted/Updated: 10/24/2014; 06/08/2015; 11/30/2016; 03/21/2017

A Randomized, Double-Masked, Parallel-Group, Phenylephrine-Controlled Study of the Effect of OMS302 Added to Standard Irrigation Solution on Intraoperative Pupil Diameter and Acute Postoperative Pain in Children Ages Birth through Three Years Undergoing Unilateral Cataract Extraction with or without Lens Replacement
Scott Lambert, MD; Phoebe Lenhart, MD
Judy Brower, COMT 

General Summary: The purpose of this study is to evaluate the study drug OMS302 in children under 3 years of age. OMS302 is a combination of phenylephrine (a dilating drop) and ketorolac (a non-steroidal anti-inflammatory drug (NSAID). Ketorolac is used to treat pain and swelling after eye surgery. It is also used to decrease swelling or redness caused by allergies. This study will compare OMS302 with phenylephrine (dilating drop) when mixed with an irrigating solution used in cataract surgery in children birth to 3 years of age. The things that will be looked at are: pupil size during surgery, pain immediately after surgery, and safety (measured by side effects). These children will be followed for 3 months in the study.

Inclusion Criteria:

- 0 - 3 years of age at the time of cataract surgery (with or without lens replacement)
- Having surgery on one eye only

Exclusion Criteria:

-Hypersensitivity to phenylephrine, ketorolac, other NSAIDs (including aspirin) or latex
- Presence of active or suspected bacterial, viral, or fungal disease in the study eye
- Post-traumatic cataract Uveitis Systemic corticosteroids or NSAIDs in the 7 days before cataract surgery
- Glaucoma medication in the study eye
- History of intraocular non-laser surgery in the study eye within 3 months before surgery, or laser surgery within 30 days before cataract surgery

Contact: Judy Brower 404-778-4725
Posted/Updated: 10/24/2014; 06/08/2015; 11/30/2016; 1/05/2017

Esotropia Treatment with Botulinum Toxin-A Injection Data Collection
PI: Scott Lambert, MD
Coordinator: Judy Brower, COMT; Marla Shainberg, CO
Status: Completed

General Summary: This registry is to determine how often botox is used for the treatment of esotropia and for what types of esotropia it is used, surgical and post-surgical complications and visual outcomes. This information will be used to determine recruitment potential for future clinical trials.

Inclusion Criteria:
- Less than 17 years of age
- Botox injection for esotropia within the past 90 days at time of enrollment

Exclusion Criteria:
- Incisional surgery at the same time as botox injection

Contact: Judy Brower, COMT, 404-778-4725
Posted/Updated: 03-12-2014; 10-27-2014; 11/30/2016

Intermittent Exotropia Study 2 (IXT2): A Randomized Clinical Trial of Observation Versus Occlusion Therapy for Intermittent Exotropia

PI: Scott Lambert, MD
Coordinator: Judy Brower, COMT; Marla Shainberg, CO
Status: Completed.

General Summary: This study is to determine whether patching an eye for 3 hours every day for at least 3 - 5 months is beneficial for intermittent exotropia. Half of the children enrolled will be instructed to patch, the other half will be observed. Visits are every 6 months (with a visit 3 months after enrollment also) for 3 years.

Inclusion Criteria:
- At least 12 months old and less than 11 years.
- Intermittent exotropia that has never been treated except with eyeglasses or contact lenses (if needed)
- Have no previous eye muscle surgery and no plans to have eye muscle surgery.

Exclusion Criteria:
- Previous treatment for intermittent exotropia other than glasses or contact lenses (patching, vision therapy)
- Amblyopia treatment within the past year
- Previous ocular surgery or botulinum injection
- Plans to have eye surgery

Contact: Judy Brower, COMT, 404-778-4725
Posted/Updates: 02-29-2012; 01-18-2013; 11-30-2016

Nasolacrimal Duct Study (PEDIG)
PI: Scott Lambert, MD
Co-Investigators:  Amy Hutchinson, MD and Phoebe Lenhart, MD
Coordinators: Rachel Robb, MMSc, CO, COMT; Marla Shainberg, CO
Status: Completed.

Summary: 6 mos to < 10 mos to compare immediate, in office probing and deferred to age 1 yr probing in OR, i.e., cost-effectiveness

Exclusion Criteria:
- Previous NLD probing

Contact: Marla Shainberg, 404-778-2928
Sponsor: NEI/JAEB Center
Last Updated: 02-29-2012

Infant Aphakia Treatment Study (IATS): Phases 1-2
PI: Scott Lambert, MD, National Study Chairman, Emory Site Investigator
Coordinators: Rachel Robb, MMSc, CO, COMT (Site); Marla Shainberg, CO (site); Lindy DuBois , MEd, MMSc, CO, COMT (National)
Status: Closed.

Summary: Comparison of visual acuity (at 1 year and 5 years of age) in children who have been treated at 1 to 6 months of age for unilateral congenital cataract with either a primarily implanted intraocular lens vs contact lenses.

Inclusion Criteria:
• Age 28-210 days at the time of cataract extraction surgery.
• Visually significant unilateral congenital cataract

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
Last Updated: 01-13-2018

A Randomized, Multicenter, Double Masked, Parallel-Group Study Assessing the Safety and Efficacy of Loteprednol Etabonate Ophthalmic Gel, 0.5% versus Prednisolone Acetate Ophthalmic Suspension , 1% for the Treatment of Intraocular Inflammation Following Surgery for Childhood Cataract

Short title: B&L Study #670 Loteprednol Gel
PI:  Phoebe Lenhart, MD
Coordinators:  Lindy DuBois, MEd, MMSc, CO, COMT;  Marla Shainberg, CO
Status:  Closed.

General Summary:
A total of 140 subjects aged 0-11 years were randomized in a 1:1 ratio to the study drug, LE Ophthalmic Gel, 0.5% or Prednisolone Acetate Ophthalmic Suspension, 1%, for the treatment of post-cataract surgery inflammation. The study will evaluate the efficacy of Loteprednol in a more convenient vehicle than the Pred Forte suspension.

Inclusion Criteria:

1. Subjects who are male or female, 0 to 11 years of age, on the date the Informed Consent Form (ICF) is signed.

2. Subject is a candidate for routine, uncomplicated surgery for childhood cataract (aspiration, with or without posterior capsulotomy with or without anterior vitrectomy, and with or without posterior chamber intraocular lens (IOL) implantation, not combined with any other surgery and without the planned use of iris hooks (Surgery/Randomization).

Exclusion Criteria:

1. Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator’s opinion, may preclude study treatment or follow-up, eg:

− presence of any active or suspected viral, bacterial, or fungal disease in the study eye

− subjects with post-traumatic cataract in the study eye

− active uveitis in the study eye

− ocular neoplasm in the study eye

2. Subjects with glaucoma, ocular hypertension, or those receiving intraocular pressure (IOP) lowering therapy in either eye or systemically.

3. Subjects with a history of steroid-induced IOP elevation in either eye.

4. Subjects who have suspected permanent low vision or blindness (eg, legal definition of blindness: visual acuity [VA] of ≤ 20/200 or visual field of ≤ 20 degrees) in the fellow non-study eye. (The study eye must not be the subject's only sighted eye.)

5. Subjects who have had ocular surgery (including laser therapy) in the study eye within 90 days prior to randomization on Visit 2 Surgery/Randomization).

6. Subjects who are expected to require treatment with systemic or ocular (study eye) corticosteroids other than study drug during the 90 days following cataract surgery or have used any systemic or ocular corticosteroids (study eye) within 14 days prior to cataract surgery. (Ocular therapy with corticosteroids in the fellow eye is permitted.)

7. Subjects who are expected to require concurrent systemic or ocular therapy (study eye) with nonsteroidal anti-inflammatory drugs (NSAIDs), or concurrent ocular therapy (either eye) with mast cell stabilizers, antihistamines, or decongestants during the 90 days following cataract surgery or have received any of the above medications within 2 days prior to surgery (intraoperative NSAIDs for mydriasis in the study eye are NOT permitted; ocular therapy with NSAIDs in the fellow eye is permitted).

8. Subjects who are expected to require concurrent ocular (either eye, eg, Restasis) or systemic immunosuppressant therapy during the 90 days following cataract surgery or have used ocular (either eye) immunosuppressants within 30 days prior to surgery or systemic immunosuppressants within 10 months prior to surgery.

9. Subject or subject’s breastfeeding mother or wet nurse who is expected to use corticosteroids (except corticosteroid inhalers and dermatological corticosteroids, as Study #670 - Protocol Amendment 6, 22 May 2013 Page 21 long as they are not used on the eyelids or surrounding area) or immunosuppressants during the 90 days following cataract surgery.

10. Subjects who have a history or presence of chronic generalized systemic disease that the Investigator believes may either increase the risk to the subject or confound the results of the study (eg, Diabetes mellitus, human immunodeficiency virus [HIV], acquired immunodeficiency syndrome [AIDS]).

11. Female subjects who have started menarche prior to Visit 1 (Screening).

12. Subjects who have known hypersensitivity or other contraindication to the study drug(s) or any components in the drug formulation.

13. Subjects who have participated in an investigational drug or device study within 30 days prior to Visit 1 (Screening).

14. Subjects who were previously randomized in this study.

Contact:  Marla Shainberg, CO; 404-778-2928
Last Updated: 01-23-2018

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