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
Infant Aphakia Treatment Study Group, Scott R Lambert, Edward G Buckley, Carolyn Drews-Botsch, Lindreth DuBois, E 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, Carey Drews-Botsch, Nana Freret, Lu Lu, Azhar Nizam, 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 Holleschau, Jason Jedlicka, Patricia Winters, Elias I Traboulsi, Susan 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 Robb, Marla J Shainberg, Edward G Buckley, Sharon F Freedman, Lois Duncan, B W Phillips, John T Petrowski, David Morrison, Sandy Owings, Ron Biernacki, Christine Franklin, David A Plager, Daniel E Neely, Michele Whitaker, Donna Bates, Dana Donaldson, Stacey Kruger, Charlotte Tibi, Susan Vega, David R Weakley, 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, Cyd Dowell, Donald F Everett, Allen Beck, Infant Aphakia Treatment Study Group, Scott R Lambert, Edward G Buckley, Carolyn Drews-Botsch, Lindreth DuBois, E 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, Carey Drews-Botsch, Nana Freret, Lu Lu, Azhar Nizam, 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 Holleschau, Jason Jedlicka, Patricia Winters, Elias I Traboulsi, Susan 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 Robb, Marla J Shainberg, Edward G Buckley, Sharon F Freedman, Lois Duncan, B W Phillips, John T Petrowski, David Morrison, Sandy Owings, Ron Biernacki, Christine Franklin, David A Plager, Daniel E Neely, Michele Whitaker, Donna Bates, Dana Donaldson, Stacey Kruger, Charlotte Tibi, Susan Vega, David R Weakley, 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, Cyd Dowell, Donald F Everett, Allen Beck
Abstract
Objective: To compare the visual outcomes and adverse events of contact lens with primary intraocular lens (IOL) correction of monocular aphakia during infancy.
Methods: In a randomized, multicenter (12 sites) clinical trial, 114 infants with a unilateral congenital cataract were assigned to undergo cataract surgery between 1 to 6 months of age either with or without primary IOL implantation. Contact lenses were used to correct aphakia in patients who did not receive IOLs. Grating visual acuity was tested at 1 year of age by a masked traveling examiner.
Main outcome measure: Grating visual acuity at 1 year of age.
Results: The median logMAR visual acuity was not significantly different between the treated eyes in the 2 groups (contact lens group, 0.80; IOL group, 0.97; P = .19). More patients in the IOL group underwent 1 or more additional intraocular operations than patients in the contact lens group (63% vs 12%; P < .001). Most of these additional operations were performed to clear lens reproliferation and pupillary membranes from the visual axis.
Conclusions: There was no statistically significant difference in grating visual acuity at age 1 year between the IOL and contact lens groups; however, additional intraocular operations were performed more frequently in the IOL group.
Application to clinical practice: Until longer-term follow-up data are available, caution should be exercised when performing IOL implantation in children aged 6 months or younger given the higher incidence of adverse events and the absence of an improved short-term visual outcome compared with contact lens use.
Trial registration: ClinicalTrials.gov NCT00212134.
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Source: PubMed