Research

Trials currently enrolling/actively recruiting

Amblyopia Treatment Study

Recruitment underway for NIH-sponsored study

Amblyopia is the most common cause of monocular visual impairment in children. The choice of a sequential approach versus a simultaneous approach to “optical treatment (glasses) plus patching treatment” remains unresolved, with some existing data supporting one approach and some data supporting the other.  There is a reasonable rationale for either approach.  This unresolved controversy results in a dichotomy of current clinical practice, with some care providers favoring one approach and others favoring the opposite approach.  In addition, the influence of adherence to patching on treatment response is not well understood.

The Pediatric Eye Disease Investigator Group (PEDIG) is conducting a clinical trial to evaluate if treating amblyopia with glasses and patching at the same time improves vision as well as treating amblyopia first with glasses and then with patching, if needed. This study will also use occlusion dose monitors (ODMs) to record adherence with prescribed patching treatment, to study dose-response. The study is supported through funding from the National Eye Institute of the U.S. National Institutes of Health and is being coordinated by the Jaeb Center for Health Research in Tampa, Florida.                      

Study Specifics

• 544 children are expected to be enrolled
• Children must be between 3 to < 13 years old
• Visual acuity in the amblyopic eye must be between 20/40 and 20/200
• Random assignment to either:
  • Sequential treatment: full-time glasses first, with subsequent patching for 2 hours per day/7 days per week if there is no further improvement in amblyopic eye visual acuity with glasses alone and there is residual amblyopia, OR
  • Simultaneous treatment: full-time glasses and part-time patching for 2 hours per day/7 days per week
• Occlusion dose monitors (ODMs) will be used to record actual patch wear time during prescribed patching
• Follow-up visits every 8 weeks for 56 weeks
• No previous treatment for amblyopia is allowed, including glasses or contact lenses.

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Previous Industry clinical trials in which we have participated

CTX: Cerebrotendinous Xanthomatosis (CTX) Prevalence Study

https://clinicaltrials.gov/ct2/show/NCT02638220

This is an observational, multicenter study to determine the prevalence of Cerebrotendinous Xanthomatosis (CTX) in patient populations diagnosed with early-onset idiopathic bilateral cataracts. Patients who are potentially eligible for study participation will be identified through a chart review of patients who were seen at each study site prior to that site's initiation, or by entering care at the site while the site is participating in the trial.

Luminopia Study

Amblyopia is one of the most common causes of vision loss in the United States and elsewhere.  Current treatment with patching or eye drops is often poorly tolerated by children and, as a result, many patients are unable to be compliant with this treatment.  In recent years, a new type of treatment for amblyopia called dichoptic training has been tried. Dichoptic training involves giving visual information to both the lazy eye and non-lazy eye simultaneously, but in different ways to try to get the lazy eye to work better.  If effective, this may be used as an alternative to traditional therapy, such as patching. The current study is for children ages 4-7 with one lazy eye with vision between 20/40 and 20/200.  The amblyopia may be due to strabismus (eyes not staying straight) or anisometropia (eyes focusing differently), which are the 2 most common causes of amblyopia

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Previous national clinical trials in which we have participated

Infant Aphakia Treatment Study

The primary purpose was to determine whether infants with a unilateral congenital cataract are more likely to develop better vision following cataract extraction surgery if they underwent primary implantation of an intraocular lens or if they were treated primarily with a contact lens. For more information: http://web1.sph.emory.edu/IATS/

Early Treatment for Retinopathy of Prematurity Study

The goal of the Early Treatment for Retinopathy of Prematurity Study (ETROP) was to test the hypothesis that earlier treatment in carefully selected cases will result in an overall better visual outcome than treatment at the conventional CRYO-ROP threshold point in the disease.

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Trials we have participated in through PEDIG (Pediatric Eye Disease Investigator Group)

ROP1: Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity

https://public.jaeb.org/pedig/stdy/335

The primary objective of the study is to determine a dose of a single intravitreal bevacizumab injection that is effective and is lower than currently used for treatment of severe (type 1) ROP.

ROP2Y: To evaluate long-term ocular and developmental outcomes in subjects originally treated with bevacizumab for severe retinopathy of prematurity in the ROP1 study.

ATS20: ATS20 Binocular Dig Rush Game Treatment for Amblyopia

https://public.jaeb.org/pedig/stdy/506

Amblyopia is one of the most common causes of vision loss in the United States and elsewhere.  Current treatment with patching or eye drops is often poorly tolerated by children and therefore not done. The goal of this study is to compare the efficacy of 1 hour/day of binocular game play 5 days per week plus spectacle correction with spectacle correction only, for treatment of amblyopia in children 4 to <13 years of age

IXT6 – Pilot Study RCT for Base-in Prism Spectacles for IXT

The goal of this study is to compare spectacles with relieving prism versus spectacles without relieving prism to determine whether to proceed to a full-scale, long-term randomized trial based on the following to manage intermittent exotropia.

IXT1 Ext –Extended Follow-Up of Subjects in the IXT1 RCT of BLR vs RRIXT1Ext - Extended

This is a follow Up of a Randomized Trial of Bilateral Lateral Rectus Recession versus Unilateral Lateral Rectus Recession with Medial Rectus Resection for Intermittent Exotropia

IXT5 – A Randomized Trial of Overminus Spectacle Therapy for Intermittent Exotropia

This is a randomized trial to determine both 1.) the long-term on-treatment effect of overminus treatment on distance IXT control scores and 2.) the off-treatment effect of overminus treatment on distance IXT control scores (following weaning and 3 months off-treatment).

PON1: pediatric optic neuritis (PON) prospective outcomes study

https://public.jaeb.org/pedig/stdy/339

1. To determine our investigators' ability to enroll children with PON into a research protocol.
2. To develop estimates of visual acuity outcomes in children with PON 6 months following enrollment.

All of these studies can be accessed via this link:https://public.jaeb.org/pedig/stdy/?Sort=ProtocolStatus&SortDirection=Desc

CEOS	CEOS - Congenital Esotropia Observation Study
ATS1	ATS01 - Occlusion versus Pharmacologic Therapy for Moderate Amblyopia
ATS2C	ATS02C - An Observational Study on Recurrence of Amblyopia After Discontinuation of Treatment
ATS05	ATS05 - A Randomized Trial to Evaluate 2 Hours of Daily Patching for Amblyopia in Children 3 to <7 Years Old
ETS01	ETS1 - An Observational Study of Infantile, Acquired Non-accommodative, and Acquired Partially-accommodative Esotropia
NLD01	NLD1 - A Prospective Study of Primary Surgical Treatment of Nasolacrimal Duct Obstruction in Children Less Than Four Years Old
NLD02	NLD2 - A Prospective Study of Surgical Procedures for the Treatment of Persistent Nasolacrimal Duct Obstruction in Children Less Than Four Years Old
ATS09	ATS09 - A Randomized Trial Comparing Patching to Atropine for Amblyopia in Children 7 to < 13 Years Old
ATS15	ATS15 - Increasing Patching for Amblyopia Study
IXT2	IXT2 - A Randomized Clinical Trial of Observation versus Occlusion Therapy for Intermittent Exotropia
ATS17	ATS17 - A Randomized Trial of Levodopa as Treatment for Residual Amblyopia
HTS1	HTS1 - Glasses versus Observation for Moderate Hyperopia in Young Children
C02	C02 - Pediatric Cataract Surgery Outcomes Registry
ATS18	ATS18 - Study of Binocular Computer Activities for Treatment of Amblyopia
IXT3	IXT3 - A Pilot Randomized Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia