Research

Research Studies & Clinical Trials

Clinical research has been a focus of Virginia Pediatric Eye Center for over 35 years. Currently, the center is actively participating in the Pediatric Eye Disease Investigative Group through funding from the National Eye Institute (NEI) at the National Institutes of Health (NIH). The studies conducted by this group have led to new and substantial advances in pediatric ophthalmology and have resulted in better treatment options and outcomes for patients. There are several research projects that are currently investigating new methods of treating various pediatric eye diseases. Patients who meet study criteria for ongoing projects are offered the opportunity to enroll in clinical trials. For more information regarding these projects and clinical studies, please discuss with your pediatric ophthalmologist or pediatric optometrist.

Current Research Studies

IXT6 Pilot RCT of Base-in Prism Spectacles for IXT

Sponsored by: PEDIG

Description: A Pilot Randomized Clinical Trial of Base-in Prism Spectacles for Intermittent Exotropia

Patient eligibility (partial list):

  • Intermittent exotropia
  • 3-13 years old

CTX study - pediatric cataract study

Sponsored by: Retrophin, Inc.

Description: An Observational, Multicenter Study of the Prevalence of Cerebrotendinous Xanthomatosis (CTX) in Patient Populations Diagnosed with Early-Onset Idiopathic Bilateral Cataracts.  

Benefits: This study involves free CTX testing.

Patient eligibility criteria  (partial list):

  • patients with bilateral cataracts may qualify for this study

Luminopia One Vision Improvement Study C-AM-2

Sponsored by: Luminopia

Description: A single-arm, multi-center, open-label pilot study to evaluate the feasibility, safety, and efficacy of the Luminopia One digital therapeutic in improving visual acuity in a pediatric amblyopia population.

Patient eligibility criteria  (partial list):

  • Aged 4-7 years may qualify for enrollment

VERTEX studies in Cystic Fibrosis Patients

Sponsored by: Vertex Pharmaceuticals, Inc.

Description: A Phase 3, 2-Part, Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor/Ivacaftor Combination Therapy in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

These studies involve CF patients who are currently receiving treatment.  We provide eye exams to rule out any developmental cataracts while on treatment.

Patient eligibility criteria: VERTEX study patients

Protocol: https://clinicaltrials.gov/ct2/show/NCT03601637?term=vertex+cystic+fibrosis&recrs=a&draw=2&rank=2

 

Sydnexis Myopia Treatment Study

Sponsored by: Sydnexis, Inc.

Description: The Safety and Efficacy of SYD-101 in Children With Myopia (STAAR) Protocol. Myopia treatment study for near-sighted patients.  STAAR protocol is a 5-arm, multicentered, randomized, double-masked, vehicle-controlled study

Patient eligibility criteria  (partial list):

  • Aged 3 to 14 years old
  • Myopia of 0.5 D (diopters) to 6.00 D (inclusive) in both eyes
  • Astigmatism ≤1.50 D in both eyes
  • Anisometropia ≤1.00 D in both eyes
  • BCVA (best-corrected visual acuity) Snellen equivalent of 20/32 or better.

IXT5 - Overminus treatment for Intermittent Exotropia

Sponsored by: PEDIG

Description: The objective of this full-scale randomized trial comparing 2.50D overminus lens treatment vs. non-overminus (spectacles without overminus or no spectacles) is to determine the efficacy of overminus lenses after 12 months of treatment.  This study has completed recruitment and is in extension study follow up.

Patient eligibility criteria (partial list):

  • Aged 3-11 years
  • Intermittent exotropia

IXT1 ext - Intermittent Exotropia Study 1 Extension

Sponsored by: PEDIG

Description: To evaluate the effectiveness of bilateral lateral rectus muscle recession versus unilateral lateral rectus recession with medial rectus resection procedures for the treatment of basic type and pseudo- divergence excess type intermittent exotropia.  This study is currently only in long term follow up for previous IXT1 patients

Patient eligibility criteria: Enrollment is complete.

Protocol: https://public.jaeb.org/pedig/stdy/336

ROP1 - Phase 1 Bevacizumab Dosing Study for Retinopathy of Prematurity

Sponsored by: PEDIG

Description: 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.  This study is currently only in long term follow up.

Patient eligibility criteria: Enrollment is complete.

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

ROP2Y - Bayley testing for ROP patients

Sponsored by: PEDIG

Description: A subset of infants enrolled in ROP1 will have extended follow up consisting of one additional office exam with developmental testing. This testing will provide a cross-sectional evaluation of visual acuity, refractive error, and development at the adjusted age 24-month visit. 24-month corrected age calculated as the estimated date of confinement (EDC), or due date, plus 24 months.  Data on this study is currently being reviewed by the steering committee

Patient eligibility criteria: Enrollment is complete.

Protocol: https://clinicaltrials.gov/ct2/show/NCT02390531

CO2 - Pediatric Cataract Registry study

Sponsored by: PEDIG

Description: To enroll individuals between birth and 13 years of age who have undergone cataract surgery in at least one eye into the data repository over a 3-year period. It is anticipated that 1000 children will be enrolled. Some children with first eye cataract surgery at enrollment may have surgery for cataract in the fellow eye at a later time. Information will be collected for outcomes related to both surgeries. If recruitment exceeds these goals we will continue to register such patients without a cap during the predetermined enrollment period.  This study is currently only in  follow up.

Patient eligibility criteria: Enrollment is complete.

Protocol: https://public.jaeb.org/pedig/stdy/204

SAS1 - Study of Adult Strabismus for Divergence Insufficiency, Convergence Insufficiency, and small angle hypertropia

Sponsored by: PEDIG

Description: To describe the clinical characteristics, treatments, and one-year outcomes of adults with convergence insufficiency, divergence insufficiency, or small angle hypertropia. Treatment comparisons within the studied conditions will also be done to help develop future studies.  This study is currently only in follow up.

Patient eligibility criteria: Enrollment is complete.

Protocol: https://public.jaeb.org/pedig/stdy/337

LUXTURNA Gene Testing

Sponsored by: Spark Therapeutics, Inc

Description: Free gene testing is available for patients with Leber congenital amaurosis (LCA), Retinitis pigmentosa (RP), Severe early childhood-onset retinal dystrophy (SECORD), Early-onset severe retinal dystrophy (EOSRD), and Early childhood-onset retinitis pigmentosa (ECRP). If you have any with these conditions, please let us know.  You may call and ask to speak with our research coordinator.

Patient eligibility criteria: Diagnosis with a covered condition

Testing Information: https://luxturnahcp.com/id-appropriate-patients/genetically-test-patients/

Luminopia C-AM-1D VR Device Pilot Study 4

Sponsored by: Luminopia Description: Free gene testing is available for patients with Leber congenital amaurosis (LCA), Retinitis pigmentosa (RP), Severe early childhood-onset retinal dystrophy (SECORD), Early-onset severe retinal dystrophy (EOSRD), and Early childhood-onset retinitis pigmentosa (ECRP). If you have any with these conditions, please let us know.  You may call and ask to speak with our research coordinator. Patient eligibility criteria: Diagnosis with a covered condition Testing Information: https://luxturnahcp.com/id-appropriate-patients/genetically-test-patients/

CHAPERONE Study

Sponsored by: Eyenovia Inc.

Description: Evaluates the progression of myopia in participants using microdosed atropine 0.01%, atropine 0.1%, or placebo ophthalmic solution. Eligible subjects will administer study medication daily in each eye for 48 months. Efficacy and safety assessments will be performed at visits scheduled for 1, 6, 12, 18, 24, 30 and 36 months after initiation of medication use. Subjects will be re-randomized at the 36 month visit, then followed at 6 month intervals for an additional year.

Patient eligibility criteria:

  • 3 Years to 12 Years
  • myopia -1.00 D to -6.00 D in both eyes
  • astigmatism ≤ 1.50 D in both eyes
  • anisometropia < 1.50 D.

Testing Information: https://clinicaltrials.gov/ct2/show/NCT03942419

Previous Research Studies

 

Nasolacrimal duct obstruction treatment studies

NLD1  A Prospective Study of Primary Surgical Treatment of Nasolacrimal Duct Obstruction in Children Less Than Four Years Old  https://public.jaeb.org/pedig/stdy/7

NLD2  A Prospective Study of Surgical Procedures for the Treatment of Persistent Nasolacrimal Duct Obstruction in Children Less Than Four Years Old  https://public.jaeb.org/pedig/stdy/8

NLD3  A Randomized Trial Comparing Immediate Probing in an Office Setting with Deferred Probing in a Facility Setting for Treatment of Nasolacrimal Duct Obstruction in Children 6 to <10 Months Old  https://public.jaeb.org/pedig/stdy/13

 

Amblyopia treatment studies

ATS1  Occlusion versus Pharmacologic Therapy for Moderate Amblyopia https://public.jaeb.org/pedig/stdy/16

ATS2A  A Randomized Trial Comparing Part-time Versus Full-time Patching for Severe Amblyopia https://public.jaeb.org/pedig/stdy/20

ATS2B  A Randomized Trial Comparing Part-time Versus Minimal-time Patching for Moderate Amblyopia https://public.jaeb.org/pedig/stdy/21

ATS2C   An Observational Study on Recurrence of Amblyopia After Discontinuation of Treatment https://public.jaeb.org/pedig/stdy/17

ATS3  An Evaluation of Treatment of Amblyopia in 7 to <18 Year Olds  https://public.jaeb.org/pedig/stdy/1

ATS4   A Randomized Trial Comparing Daily Atropine Versus Weekend Atropine for Moderate Amblyopia https://public.jaeb.org/pedig/stdy/18

ATS5  A Randomized Trial to Evaluate 2 Hours of Daily Patching for Amblyopia in Children 3 to <7 Years Old   https://public.jaeb.org/pedig/stdy/2

ATS6  A Randomized Trial of Near versus Distance Activities while Patching for Amblyopia in Children 3 to < 7 years old  https://public.jaeb.org/pedig/stdy/3

ATS7  Bilateral Refractive Amblyopia Treatment Study: Response to Treatment of Previously Untreated Presumed Bilateral Refractive Amblyopia    https://public.jaeb.org/pedig/stdy/4

ATS8  A Randomized Trial Comparing Atropine to Atropine plus a Plano Lens for the Sound Eye as Prescribed Treatments for Amblyopia in Children 3 to < 7 Years Old  https://public.jaeb.org/pedig/stdy/5

ATS9  A Randomized Trial Comparing Patching to Atropine for Amblyopia in Children 7 to < 13 Years Old   https://public.jaeb.org/pedig/stdy/6

ATS10 A Randomized Trial of Full-time Bangerter Filters versus Part-time Daily Patching for the Treatment of Moderate Amblyopia in Children   https://public.jaeb.org/pedig/stdy/31

ATS11   A Randomized Trial to Evaluate Combined Patching-Atropine Treatment for Residual Amblyopia   https://public.jaeb.org/pedig/stdy/24

ATS12  A Randomized Trial Comparing Patching with Active Vision Therapy to Patching with Control Vision Therapy as Treatment for Amblyopia in Children 7 to <13 Years Old   https://public.jaeb.org/pedig/stdy/35

ATS13  An Observational Study of Optical Correction for Strabismic Amblyopia in Children 3 to <7 Years Old  https://public.jaeb.org/pedig/stdy/10

ATS15 Increasing Patching for Amblyopia Study  https://public.jaeb.org/pedig/stdy/29

ATS16 Augmenting Atropine Treatment for Amblyopia Study  https://public.jaeb.org/pedig/stdy/30

ATS17  A Randomized Trial of Levodopa as Treatment for Residual Amblyopia  https://public.jaeb.org/pedig/stdy/196

ATS18   Study of Binocular Computer Activities for Treatment of Amblyopia  https://public.jaeb.org/pedig/stdy/235

ATS20   Binocular Dig Rush Game Treatment for Amblyopia  https://public.jaeb.org/pedig/stdy/506

X01   Correction of Refractive Error for Amblyopia Protocol  https://public.jaeb.org/pedig/stdy/9

HTS1  Glasses versus Observation for Moderate Hyperopia in Young Children  https://public.jaeb.org/pedig/stdy/200

 

Strabismus studies  (Esotropia, Exotropia, Hypertropia)

CEOS –  Congenital Esotropia Observation Study  https://public.jaeb.org/pedig/stdy/19

IXT1 – A Randomized Trial of Bilateral Lateral Rectus Recession versus Unilateral Lateral Rectus Recession with Medial Rectus Resection for Intermittent Exotropia  https://public.jaeb.org/pedig/stdy/153

IXT1Ext – Extended Follow Up of a Randomized Trial of Bilateral Lateral Rectus Recession versus Unilateral Lateral Rectus Recession with Medial Rectus Resection for Intermittent Exotropia  https://public.jaeb.org/pedig/stdy/336

IXT2 – A Randomized Clinical Trial of Observation versus Occlusion Therapy for Intermittent Exotropia   https://public.jaeb.org/pedig/stdy/154

IXT3 – A Pilot Randomized Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia  https://public.jaeb.org/pedig/stdy/236

IXT5 – A Randomized Clinical Trial of Overminus Spectacle Therapy for Intermittent Exotropia   https://public.jaeb.org/pedig/stdy/341

SAS1 – A Prospective Observational Study of Adult Convergence Insufficiency, Divergence insufficiency, and Small-angle Hypertropia  https://public.jaeb.org/pedig/stdy/337

 

Retinopathy of Prematurity Studies

ROP1 – Phase 1 Trial of Bevacizumab Treatment for Severe Retinopathy of Prematurity  https://public.jaeb.org/pedig/stdy/335

ROP2A – Extension of ROP1 with 2 year outcomes https://public.jaeb.org/pedig/stdy/335