The infant aphakia treatment study: design and clinical measures at enrollment
Infant Aphakia Treatment Study Group, Scott R Lambert, Edward G Buckley, Carolyn Drews-Botsch, Lindreth DuBois, Eugenie Hartmann, Michael J Lynn, David A Plager, M Edward Wilson, Scott R Lambert, Lindreth DuBois, Michael Lynn, Betsy Bridgman, Marianne Celano, Julia Cleveland, George Cotsonis, Carolyn Drews-Botsch, Nana Freret, Lu Lu, Seegar Swanson, Thandeka Tutu-Gxashe, E Eugenie Hartmann, Clara Edwards, Claudio Busettini, Samuel Hayley, Scott R Lambert, Edward G Buckley, David A Plager, M Edward Wilson, Michael Lynn, Lindreth DuBois, Carolyn Drews-Botsch, E Eugenie Hartmann, Donald F Everett, Buddy Russell, Michael Ward, M Edward Wilson, Margaret Bozic, Deborah K VanderVeen, Theresa A Mansfield, Kathryn Bisceglia Miller, Stephen P Christiansen, Erick D Bothun, Ann M Holleschau, Jason Jedlicka, Patricia M Winters, Elias I Traboulsi, Susan S Crowe, Heather Hasley Cimino, Kimberly G Yen, Maria Castanes, Alma Sanchez, Shirley York, David T Wheeler, Ann U Stout, Paula Rauch, Kimberly Beaudet, Pam Berg, Scott R Lambert, Amy K Hutchinson, Lindreth DuBois, Rachel Reeves, Marla J Shainberg, Edward G Buckley, Sharon F Freedman, Lois Duncan, B W Phillips, John T Petrowski, David G Morrison, Sandy Owings, Ron Biernacki, Christine Franklin, David A Plager, Daniel E Neely, Michele Whitaker, Donna Bates, Dana Donaldson, Stacey J Kruger, Charlotte Tibi, Susan Vega, David R Weakley Jr, David R Stager Jr, Joost Felius, Clare Dias, Debra L Sager, Todd Brantley, Robert Hardy, Eileen Birch, Ken Cheng, Richard Hertle, Craig Kollman, Marshalyn Yeargin-Allsopp, Cindy Bachman, Donald F Everett, Allen Beck, Infant Aphakia Treatment Study Group, Scott R Lambert, Edward G Buckley, Carolyn Drews-Botsch, Lindreth DuBois, Eugenie Hartmann, Michael J Lynn, David A Plager, M Edward Wilson, Scott R Lambert, Lindreth DuBois, Michael Lynn, Betsy Bridgman, Marianne Celano, Julia Cleveland, George Cotsonis, Carolyn Drews-Botsch, Nana Freret, Lu Lu, Seegar Swanson, Thandeka Tutu-Gxashe, E Eugenie Hartmann, Clara Edwards, Claudio Busettini, Samuel Hayley, Scott R Lambert, Edward G Buckley, David A Plager, M Edward Wilson, Michael Lynn, Lindreth DuBois, Carolyn Drews-Botsch, E Eugenie Hartmann, Donald F Everett, Buddy Russell, Michael Ward, M Edward Wilson, Margaret Bozic, Deborah K VanderVeen, Theresa A Mansfield, Kathryn Bisceglia Miller, Stephen P Christiansen, Erick D Bothun, Ann M Holleschau, Jason Jedlicka, Patricia M Winters, Elias I Traboulsi, Susan S Crowe, Heather Hasley Cimino, Kimberly G Yen, Maria Castanes, Alma Sanchez, Shirley York, David T Wheeler, Ann U Stout, Paula Rauch, Kimberly Beaudet, Pam Berg, Scott R Lambert, Amy K Hutchinson, Lindreth DuBois, Rachel Reeves, Marla J Shainberg, Edward G Buckley, Sharon F Freedman, Lois Duncan, B W Phillips, John T Petrowski, David G Morrison, Sandy Owings, Ron Biernacki, Christine Franklin, David A Plager, Daniel E Neely, Michele Whitaker, Donna Bates, Dana Donaldson, Stacey J Kruger, Charlotte Tibi, Susan Vega, David R Weakley Jr, David R Stager Jr, Joost Felius, Clare Dias, Debra L Sager, Todd Brantley, Robert Hardy, Eileen Birch, Ken Cheng, Richard Hertle, Craig Kollman, Marshalyn Yeargin-Allsopp, Cindy Bachman, Donald F Everett, Allen Beck
Abstract
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.
Main outcome measures: Grating acuity at 12 months of age and HOTV visual acuity at 4 1/2 years of age.
Application to clinical practice: 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.
Trial registration: ClinicalTrials.gov NCT00212134.
Source: PubMed