Monocular congenital cataracts continue to be a blinding disease in most affected eyes with the currently used surgical techniques techniques and contact lens correction. Monkey studies and pilot studies in human infants suggest an improved visual outcome can be achieved with intraocular lenses (IOLs) compared to contact lenses and pediatric ophthalmologists have begun to experiment with IOL implantation in children and even infants. However, there may be greater complications with IOLs in younger children. Therefore, this NEI Clinical Trial Planning Project proposes to develop a randomized clinical trial that will compare the relative efficacy, safety, and benefits of IOL and contact lens correction of infants with monocular aphakia to determine if and how IOL implantation might be implemented in young infants. The major endpoint of the study will be the visual outcome of these eyes. We will also compare the incidence of ocular complications, axial growth, strabismus, and the myopic shift. The proposed pilot studies during the planning project will determine surgical protocols, testing procedures, and sample sizes. In addition, pilot studies will determine the feasibility of evaluating additional parameters such as the parental stress associated with these two treatments. The pilot studies will be performed at 8 clinical center by pediatric ophthalmologists who have extensive experience implanting IOLs in children.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Exploratory/Developmental Grants (R21)
Project #
1R21EY011987-01A1
Application #
2689307
Study Section
Special Emphasis Panel (ZEY1-VSN (06))
Project Start
1998-09-01
Project End
2000-08-31
Budget Start
1998-09-01
Budget End
2000-08-31
Support Year
1
Fiscal Year
1998
Total Cost
Indirect Cost
Name
Emory University
Department
Ophthalmology
Type
Schools of Medicine
DUNS #
042250712
City
Atlanta
State
GA
Country
United States
Zip Code
30322
VanderVeen, Deborah K; Nizam, Azhar; Lynn, Michael J et al. (2012) Predictability of intraocular lens calculation and early refractive status: the Infant Aphakia Treatment Study. Arch Ophthalmol 130:293-9
Plager, David A; Lynn, Michael J; Buckley, Edward G et al. (2011) Complications, adverse events, and additional intraocular surgery 1 year after cataract surgery in the infant Aphakia Treatment Study. Ophthalmology 118:2330-4
Infant Aphakia Treatment Study Group; Lambert, Scott R; Buckley, Edward G et al. (2010) A randomized clinical trial comparing contact lens with intraocular lens correction of monocular aphakia during infancy: grating acuity and adverse events at age 1 year. Arch Ophthalmol 128:810-8
Infant Aphakia Treatment Study Group; Lambert, Scott R; Buckley, Edward G et al. (2010) The infant aphakia treatment study: design and clinical measures at enrollment. Arch Ophthalmol 128:21-7
Lambert, Scott R; Plager, David A; Lynn, Michael J et al. (2008) Visual outcome following the reduction or cessation of patching therapy after early unilateral cataract surgery. Arch Ophthalmol 126:1071-4
Lambert, S R; Lynn, M; Drews-Botsch, C et al. (2001) A comparison of grating visual acuity, strabismus, and reoperation outcomes among children with aphakia and pseudophakia after unilateral cataract surgery during the first six months of life. J AAPOS 5:70-5
Lambert, S R; Buckley, E G; Plager, D A et al. (1999) Unilateral intraocular lens implantation during the first six months of life. J AAPOS 3:344-9