Complications in the first 5 years following cataract surgery in infants with and without intraocular lens implantation in the Infant Aphakia Treatment Study
David A Plager, Michael J Lynn, Edward G Buckley, M Edward Wilson, Scott R Lambert, Infant Aphakia Treatment Study Group, David A Plager, Michael J Lynn, Edward G Buckley, M Edward Wilson, Scott R Lambert, Scott R Lambert, Lindreth DuBois, 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, Robert Hardy, Eileen Birch, Ken Cheng, Richard Hertle, Craig Kollman, Marshalyn Yeargin-Allsopp, Cyd McDowell, Donald F Everett, Michael Lynn, Betsy Bridgman, Marianne Celano, Julia Cleveland, George Cotsonis, Carey Drews-Botsch, Nana Freret, Lu Lu, Seegar Swanson, Thandeka Tutu-Gxashe, Claudio Busettini, Samuel Hayley, Joost Felius, Allen Beck, Donald F Everett, E Eugenie Hartmann, Anna K Carrigan, Clara Edwards, 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, Jacob Lang, Elias I Traboulsi, Susan Crowe, Heather Hasley Cimino, Kimberly G Yen, Maria Castanes, Alma Sanchez, Shirley York, Scott R Lambert, Amy K Hutchinson, Lindreth Dubois, Rachel Robb, Marla J Shainberg, David T Wheeler, Ann U Stout, Paula Rauch, Kimberly Beaudet, Pam Berg, 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, Faruk Orge, David A Plager, Michael J Lynn, Edward G Buckley, M Edward Wilson, Scott R Lambert, Infant Aphakia Treatment Study Group, David A Plager, Michael J Lynn, Edward G Buckley, M Edward Wilson, Scott R Lambert, Scott R Lambert, Lindreth DuBois, 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, Robert Hardy, Eileen Birch, Ken Cheng, Richard Hertle, Craig Kollman, Marshalyn Yeargin-Allsopp, Cyd McDowell, Donald F Everett, Michael Lynn, Betsy Bridgman, Marianne Celano, Julia Cleveland, George Cotsonis, Carey Drews-Botsch, Nana Freret, Lu Lu, Seegar Swanson, Thandeka Tutu-Gxashe, Claudio Busettini, Samuel Hayley, Joost Felius, Allen Beck, Donald F Everett, E Eugenie Hartmann, Anna K Carrigan, Clara Edwards, 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, Jacob Lang, Elias I Traboulsi, Susan Crowe, Heather Hasley Cimino, Kimberly G Yen, Maria Castanes, Alma Sanchez, Shirley York, Scott R Lambert, Amy K Hutchinson, Lindreth Dubois, Rachel Robb, Marla J Shainberg, David T Wheeler, Ann U Stout, Paula Rauch, Kimberly Beaudet, Pam Berg, 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, Faruk Orge
Abstract
Purpose: To compare rates and severity of complications between infants undergoing cataract surgery with and without intraocular lens (IOL) implantation.
Design: Prospective randomized clinical trial.
Methods: A total of 114 infants were enrolled in the Infant Aphakia Treatment Study, a randomized, multi-center (12) clinical trial comparing the treatment of unilateral aphakia in patients under 7 months of age with a primary IOL implant or contact lens. The rate, character, and severity of intraoperative complications, adverse events, and additional intraocular surgeries during the first 5 postoperative years in the 2 groups were examined.
Results: There were more patients with intraoperative complications (28% vs 11%, P = .031), adverse events (81% vs 56%, P = .008), and more additional intraocular surgeries (72% vs 16%, P < .0001) in the IOL group than in the contact lens group. However, the number of patients with adverse events in the contact lens group increased (15 to 24) in postoperative years 2-5 compared to the first postoperative year, while it decreased (44 to 14) in years 2-5 compared to the first postoperative year in the IOL group. If only one half of the patients in the contact lens (aphakic) group eventually undergo secondary IOL implantation, the number of additional intraocular surgeries in the 2 groups will be approximately equal.
Conclusion: The increased rate of complications, adverse events, and additional intraocular surgeries associated with IOL implantation in infants <7 months of age militates toward leaving babies aphakic if it is considered likely that the family will be successful with contact lens correction.
Trial registration: ClinicalTrials.gov NCT00212134.
Copyright © 2014 Elsevier Inc. All rights reserved.
Source: PubMed