Intraocular lenses (IOLs) are now accepted treatment for cataracts in older children and are being used increasingly in younger children and even infants, but little is known about the safety or the appropriate power to implant in a rapidly growing eye. Available data suggest that a fair-to-good visual acuity outcome can be more consistently obtained in infants with a unilateral congenital cataract who undergo IOL implantation at the time of cataract surgery, but the methods used to assess the visual outcome in these series have been nonstandardized and may have overestimated the visual acuity of the pseudophakic eyes. Moreover, these series have generally reported more complications in pseudophakic than aphakic eyes. Therefore, the question - What is the best way to treat infants with unilateral aphakia? - remains unanswered. The objective of this randomized multicenter clinical trial is to compare two treatments for infants with a unilateral congenital cataract. The control group will receive the conventional treatment that involves cataract surgery followed by optical treatment with a contact lens and later coupled with spectacle treatment. The experimental group will also undergo cataract surgery but in addition will have an IOL implanted during the same surgery. The IOL will serve as the primary optical treatment any residual refractive error will be corrected with spectacles. This randomized, multi-center clinical trial will: 1) determine whether infants with a unilateral congenital cataract are more likely to have an interocular acuity difference of less than 0.2 LogMAR when 12 months of age if they undergo primary implantation of an IOL or if they are corrected primarily with a contact lens;2) determine whether more complications develop and reoperations are necessary in eyes undergoing the primary implantation of an IOL;and 3) determine whether parents of infants with a unilateral congenital cataract experience less parenting stress if their child is primarily treated with an IOL. The public health importance of this trial not only involves the approximately 300 children born each year in the United States with a unilateral congenital cataract, but also the many more children born each year with bilateral cataracts or who acquire a cataract during early childhood.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10EY013272-09
Application #
8293270
Study Section
Special Emphasis Panel (ZEY1-VSN (08))
Program Officer
Everett, Donald F
Project Start
2004-07-01
Project End
2013-09-29
Budget Start
2012-06-01
Budget End
2013-09-29
Support Year
9
Fiscal Year
2012
Total Cost
$846,267
Indirect Cost
$117,064
Name
Emory University
Department
Ophthalmology
Type
Schools of Medicine
DUNS #
066469933
City
Atlanta
State
GA
Country
United States
Zip Code
30322
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Kumar, Priyanka; Lambert, Scott R (2016) Evaluating the evidence for and against the use of IOLs in infants and young children. Expert Rev Med Devices 13:381-9
Drews-Botsch, Carolyn; Cotsonis, George; Celano, Marianne et al. (2016) Assessment of Adherence to Visual Correction and Occlusion Therapy in the Infant Aphakia Treatment Study. Contemp Clin Trials Commun 3:158-166
Bothun, Erick D; Lynn, Michael J; Christiansen, Stephen P et al. (2016) Sensorimotor outcomes by age 5 years after monocular cataract surgery in the Infant Aphakia Treatment Study (IATS). J AAPOS 20:49-53
Lee, Yeon-Hee; Lenhart, Phoebe D; Lambert, Scott R (2016) Cataract secondary to self-inflicted blunt trauma in children with autism spectrum disorder. J AAPOS 20:361-2
Lambert, Scott R; Cotsonis, George; DuBois, Lindreth et al. (2016) Comparison of the rate of refractive growth in aphakic eyes versus pseudophakic eyes in the Infant Aphakia Treatment Study. J Cataract Refract Surg 42:1768-1773
Russell, Buddy; DuBois, Lindreth; Lynn, Michael et al. (2016) The Infant Aphakia Treatment Study Contact Lens Experience to Age of 5 Years. Eye Contact Lens :
Celano, Marianne; Hartmann, E Eugenie; DuBois, Lindreth G et al. (2016) Motor skills of children with unilateral visual impairment in the Infant Aphakia Treatment Study. Dev Med Child Neurol 58:154-9
Traboulsi, E I; Vanderveen, D; Morrison, D et al. (2016) Associated systemic and ocular disorders in patients with congenital unilateral cataracts: the Infant Aphakia Treatment Study experience. Eye (Lond) 30:1170-4
Lambert, S R; DuBois, L; Cotsonis, G et al. (2016) Factors associated with stereopsis and a good visual acuity outcome among children in the Infant Aphakia Treatment Study. Eye (Lond) 30:1221-8

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