The Pediatric Ophthalmology division participates in many ongoing PEDIG studies as well as the Infant Aphakia Treatment Study and independent projects. Some of these studies are listed below. Additional information can be obtained by contacting our pediatric research coordinator, Lisa Fraine, C.O.
Pediatric Eye Disease Investigator Group (PEDIG) Studies
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
To determine the cost-effectiveness of treating NLDO using immediate office probing compared with deferred probing in a facility setting. The study will determine the proportion of eyes experiencing spontaneous resolution among subjects randomized to the deferred probing group.
To determine the success proportion for eyes undergoing:
Immediate office probing as an initial procedure.
Deferred facility probing as an initial procedure.
A Randomized Clinical Trial of Observation versus Occlusion Therapy for Intermittent Exotropia (IXT)
To determine the effectiveness of occlusion for the treatment of IXT among patients aged 3 to <11 years
To determine the natural history of IXT among patients aged 3 to <11 years
A Randomized Trial of Bilateral Lateral Rectus Recession versus Unilateral Lateral Rectus Recession with Medial Rectus Resection for Intermittent Exotropia
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 in children 3 to <11.
Increasing Patching for Amblyopia Study
To determine if increasing patching dosage will improve visual acuity in patients with amblyopia still present after visual acuity has stabilized with initial treatment.
The study aims to evaluate the effectiveness of increasing prescribed patching treatment from 2 to 6 daily hours after visual acuity has stabilized with initial treatment and amblyopia is still present. Children ages 3 to <8 years with visual acuity of 20/50 to 20/400 in the amblyopic eye will be enrolled in a run-in phase with 2 hours daily patching until no improvement, followed by randomization of eligible patients to patching 2 hours daily versus an average of 6 hours daily (42 hours per week).
Augmenting Atropine Treatment for Amblyopia Study
To determine if adding a plano lens to weekend atropine will improve visual acuity in patients with amblyopia still present after visual acuity has stabilized with initial treatment.
This study is designed to evaluate the effectiveness of adding a plano lens to weekend atropine after visual acuity has stabilized with weekend atropine but amblyopia is still present. Children ages 3 to <8 years with visual acuity of 20/50 to 20/400 in the amblyopic eye will be enrolled in a run-in phase with weekend atropine until no improvement, followed by randomization of eligible patients to weekend atropine treatment with a plano lens over the sound eye versus without a plano lens over the sound eye.
Long Term Follow Up of Amblyopia Treatment (IN FOLLOW UP ONLY)
Extended follow up of study patients is ongoing with visits at age 15 years.
Objective of Extended Follow up of Study Patients:
Primary: To determine the long-term visual acuity outcome at age 10 years and at age 15 years in patients diagnosed with amblyopia before age 7 years.
Secondary: To determine whether the long-term visual acuity outcome at age 10 years and at age 15 years differs between patients who received patching followed by best clinical care and patients who received atropine followed by best clinical care.
Correction of Refractive Error for Amblyopia Protocol
The Pediatric Eye Disease Investigator Group (PEDIG) is conducting a series of clinical trials of children with amblyopia. Prior to enrollment into one of the trials, it is necessary for the child’s refractive error to be corrected with spectacles. The purpose of this protocol is to provide the requisite spectacles when refractive error has not already been appropriately corrected and then to follow the child according to the investigator’s usual routine until visual acuity is stable. At that time, if amblyopia is still present, the child’s eligibility for an amblyopia treatment protocol will be assessed.
Other Pediatric Eye Studies
Reliability of the Aniseikonia Inspector (Version 3) in School-Aged Children
This study is designed to test the Aniseikonia Inspector (Version 3), a commercially-available, computer-based, non-invasive test. The goal is to determine if children in the 5 – 13 age range are able to take the test reliably. Future work will focus on using this instrument in children with anisometropia with the intent to shed more light on the treatment and pathogenesis of anisometropic amblyopia.
A Prospective Evaluation of VEP Testing For Children
This study is designed to find a better way to detect amblyopia in children. Amblyopia can be caused by strabismus (misalignment of the eyes), media opacity (cataract), or the need for glasses prescription (high bilateral refractive error or anisometropia.) While strabismus and media opacity are often noticeable to parents and pediatricians, the need for glasses is often silent and asymptomatic. Currently pediatricians, ophthalmologists, and optometrists attempt to detect amblyopia by having a child read an eye chart. This is problematic for many children, especially for pre-verbal children and non-verbal children. The study uses a commercially-available device that measures visual-evoked potential to screen for amblyopia. Children with normal vision and children with amblyopia (or risk factors for amblyopia) will undergo testing. Their results will be compared, in an attempt to help improve the diagnostic efficiency of the instrument.
Ongoing Vision Screening Studies
Review of Results of Preschool Vision Screening, Parts 1 and 2
This study evaluates the exam results from children whose vision is screened using various commercially available vision screening instruments. Children who fail the eye screening criteria will be referred to and examined by physicians in the Vanderbilt Ophthalmology practice, and by local Optometrists and Ophthalmologists. The study aims to determine the reliability of vision screening instruments.
Long-term Follow-up of Patients with Amblyopia Initially Identified by Photoscreening
This study presents long term follow-up data on pre-school patients identified with amblyogenic risk factors by positive photoscreening.