Ophthalmology

Trials currently enrolling/actively recruiting

ROP2Y: Enrolling by Invitation

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

CTX: Cerebrotendinous Xanthomatosis (CTX) Prevalence Study

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.

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.

Studies in follow up

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.

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.

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).

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

Upcoming studies

ATS19: Amblyopia Treatment Study 19 - Excimer Laser Surgery for Anisometropic Amblyopia

https://public.jaeb.org/pedig/stdy/507

The goal of this study is to compare the efficacy and safety of laser surgical treatment (PRK) versus non-surgical treatment of anisometropic amblyopia in children who have failed conventional treatment due to non-compliance or non-response.

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.

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.

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

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