The infant aphakia treatment study: design and clinical measures at enrollment.
OBJECTIVE
To compare the use of contact lenses and intraocular lenses (IOLs) for the optical correction of unilateral aphakia during infancy.


METHODS
In a randomized, multicenter (12 sites) clinical trial, 114 infants with unilateral congenital cataracts were assigned to undergo cataract surgery with or without IOL implantation. Children randomized to IOL treatment had their residual refractive error corrected with spectacles. Children randomized to no IOL treatment had their aphakia treated with a contact lens.


METHODS
Grating acuity at 12 months of age and HOTV visual acuity at 4 1/2 years of age.


CONCLUSIONS
This study should determine whether either treatment for an infant with a visually significant unilateral congenital cataract results in a better visual outcome.


RESULTS
Enrollment began December 23, 2004, and was completed January 16, 2009. The median age at the time of cataract surgery was 1.8 months. Fifty patients were 4 to 6 weeks of age at the time of enrollment; 32, 7 weeks to 3 months of age; and the remaining 32, more than 3 to less than 7 months of age. Fifty-seven children were randomized to each treatment group. Eyes with cataracts had shorter axial lengths and steeper corneas on average than the fellow eyes.


CONCLUSIONS
The optimal optical treatment of aphakia in infants is unknown. However, the Infant Aphakia Treatment Study was designed to provide empirical evidence of whether optical treatment with an IOL or a contact lens after unilateral cataract surgery during infancy is associated with a better visual outcome.
Lambert
Scott R
SR
Buckley
Edward G
EG
Drews-Botsch
Carolyn
C
DuBois
Lindreth
L
Hartmann
Eugenie
E
Lynn
Michael J
MJ
Plager
David A
DA
Wilson
M Edward
ME
D001036:Aphakia, Postcataract / Q000503:physiopathology* / Q000628:therapy; D002386:Cataract / Q000151:congenital*; D002387:Cataract Extraction; D003261:Contact Lenses; D005133:Eye Movements / Q000502:physiology; D005139:Eyeglasses; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007223:Infant; D019654:Lens Implantation, Intraocular; D008297:Male; D019591:Pseudophakia / Q000503:physiopathology* / Q000628:therapy; D012030:Refractive Errors / Q000503:physiopathology* / Q000628:therapy; D012107:Research Design; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology*