Closed Pediatric Ophthalmology Trials

 

Binocular Computer Activities for Treatment of Amblyopia (ATS18)
PI: Scott Lambert, MD
Coordinator: Judy Brower
Status: Completed.

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

 

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

General 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
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
PI:
Scott Lambert, MD
Coordinator:
Judy Brower
Status:
Completed.

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

 

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
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

 

Esotropia Treatment with Botulinum Toxin-A Injection Data Collection
PI: Scott Lambert, MD
Coordinator: Judy Brower
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

 

Infant Aphakia Treatment Study (IATS)
PI: Scott Lambert, MD, National Study Chairman, Emory Site Investigator
Coordinators: Rachel Robb, MMSc, CO, COMT (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: Rachel Robb, 404-778-5134
Sponsor: NIH/NEI

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