The infant aphakia treatment study: Design and clinical measures at enrollment

Scott R. Lambert; Edward G. Buckley; Carolyn Drews-Botsch; Lindreth DuBois; Eugenie Hartmann; Michael J. Lynn; David A. Plager; M. Edward Wilson; Betsy Bridgman; Marianne Celano; Julia Cleveland; George Cotsonis; Nana Freret; Lu Lu; Seegar Swanson; Thandeka Tutu-Gxashe; Clara Edwards; Claudio Busettini; Samuel Hayley; Donald F. Everett; Buddy Russell; Michael Ward; 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; Amy K. Hutchinson; Rachel Reeves; Marla J. Shainberg; Sharon F. Freedman; Lois Duncan; B. W. Phillips; John T. Petrowski; David G. Morrison; Sandy Owings; Ron Biernacki; Christine Franklin; Daniel E. Neely; Michele Whitaker; Donna Bates; Dana Donaldson; Stacey J. Kruger; Charlotte Tibi; Susan Vega; David R. Weakley; David R. Stager; Joost Felius; Clare Dias; Debra L. Sager; Todd Brantley; Robert Hardy; Eileen Birch; Ken Cheng; Richard Hertle; Craig Kollman; Marshalyn Yeargin-Allsopp; Cindy Bachman; Allen Beck

doi:10.1001/archophthalmol.2009.350

The infant aphakia treatment study: Design and clinical measures at enrollment

Scott R. Lambert, Edward G. Buckley, Carolyn Drews-Botsch, Lindreth DuBois, Eugenie Hartmann, Michael J. Lynn, David A. Plager, M. Edward Wilson, Betsy Bridgman, Marianne Celano, Julia Cleveland, George Cotsonis, Nana Freret, Lu Lu, Seegar Swanson, Thandeka Tutu-Gxashe, Clara Edwards, Claudio Busettini, Samuel Hayley, Donald F. EverettBuddy Russell, Michael Ward, 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, Amy K. Hutchinson, Rachel Reeves, Marla J. Shainberg, Sharon F. Freedman, Lois Duncan, B. W. Phillips, John T. Petrowski, David G. Morrison, Sandy Owings, Ron Biernacki, Christine Franklin, Daniel E. Neely, Michele Whitaker, Donna Bates, Dana Donaldson, Stacey J. Kruger, Charlotte Tibi, Susan Vega, David R. Weakley, David R. Stager, Joost Felius, Clare Dias, Debra L. Sager, Todd Brantley, Robert Hardy, Eileen Birch, Ken Cheng, Richard Hertle, Craig Kollman, Marshalyn Yeargin-Allsopp, Cindy Bachman, Allen Beck

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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 41/2 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 weeksofageatthetimeofenrollment;32,7weeksto3months ofage;andtheremaining32, morethan3tolessthan7months 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 Identifier: NCT00212134.

Original language	English (US)
Pages (from-to)	21-27
Number of pages	7
Journal	Archives of Ophthalmology
Volume	128
Issue number	1
DOIs	https://doi.org/10.1001/archophthalmol.2009.350
State	Published - Jan 2010

ASJC Scopus subject areas

Ophthalmology

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10.1001/archophthalmol.2009.350

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Lambert, S. R., Buckley, E. G., Drews-Botsch, C., DuBois, L., Hartmann, E., Lynn, M. J., Plager, D. A., Wilson, M. E., Bridgman, B., Celano, M., Cleveland, J., Cotsonis, G., Freret, N., Lu, L., Swanson, S., Tutu-Gxashe, T., Edwards, C., Busettini, C., Hayley, S., ... Beck, A. (2010). The infant aphakia treatment study: Design and clinical measures at enrollment. Archives of Ophthalmology, 128(1), 21-27. https://doi.org/10.1001/archophthalmol.2009.350

Lambert, SR, Buckley, EG, Drews-Botsch, C, DuBois, L, Hartmann, E, Lynn, MJ, Plager, DA, Wilson, ME, Bridgman, B, Celano, M, Cleveland, J, Cotsonis, G, Freret, N, Lu, L, Swanson, S, Tutu-Gxashe, T, Edwards, C, Busettini, C, Hayley, S, Everett, DF, Russell, B, Ward, M, Bozic, M, VanderVeen, DK, Mansfield, TA, Miller, KB, Christiansen, SP, Bothun, ED, Holleschau, AM, Jedlicka, J, Winters, PM, Traboulsi, EI, Crowe, SS, Cimino, HH, Yen, KG, Castanes, M, Sanchez, A, York, S, Wheeler, DT, Stout, AU, Rauch, P, Beaudet, K, Berg, P, Hutchinson, AK, Reeves, R, Shainberg, MJ, Freedman, SF, Duncan, L, Phillips, BW, Petrowski, JT, Morrison, DG, Owings, S, Biernacki, R, Franklin, C, Neely, DE, Whitaker, M, Bates, D, Donaldson, D, Kruger, SJ, Tibi, C, Vega, S, Weakley, DR, Stager, DR, Felius, J, Dias, C, Sager, DL, Brantley, T, Hardy, R, Birch, E, Cheng, K, Hertle, R, Kollman, C, Yeargin-Allsopp, M, Bachman, C & Beck, A 2010, 'The infant aphakia treatment study: Design and clinical measures at enrollment', Archives of Ophthalmology, vol. 128, no. 1, pp. 21-27. https://doi.org/10.1001/archophthalmol.2009.350

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title = "The infant aphakia treatment study: Design and clinical measures at enrollment",

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 41/2 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 weeksofageatthetimeofenrollment;32,7weeksto3months ofage;andtheremaining32, morethan3tolessthan7months 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 Identifier: NCT00212134.",

author = "Lambert, {Scott R.} and Buckley, {Edward G.} and Carolyn Drews-Botsch and Lindreth DuBois and Eugenie Hartmann and Lynn, {Michael J.} and Plager, {David A.} and Wilson, {M. Edward} and Betsy Bridgman and Marianne Celano and Julia Cleveland and George Cotsonis and Nana Freret and Lu Lu and Seegar Swanson and Thandeka Tutu-Gxashe and Clara Edwards and Claudio Busettini and Samuel Hayley and Everett, {Donald F.} and Buddy Russell and Michael Ward and Margaret Bozic and VanderVeen, {Deborah K.} and Mansfield, {Theresa A.} and Miller, {Kathryn Bisceglia} and Christiansen, {Stephen P.} and Bothun, {Erick D.} and Holleschau, {Ann M.} and Jason Jedlicka and Winters, {Patricia M.} and Traboulsi, {Elias I.} and Crowe, {Susan S.} and Cimino, {Heather Hasley} and Yen, {Kimberly G.} and Maria Castanes and Alma Sanchez and Shirley York and Wheeler, {David T.} and Stout, {Ann U.} and Paula Rauch and Kimberly Beaudet and Pam Berg and Hutchinson, {Amy K.} and Rachel Reeves and Shainberg, {Marla J.} and Freedman, {Sharon F.} and Lois Duncan and Phillips, {B. W.} and Petrowski, {John T.} and Morrison, {David G.} and Sandy Owings and Ron Biernacki and Christine Franklin and Neely, {Daniel E.} and Michele Whitaker and Donna Bates and Dana Donaldson and Kruger, {Stacey J.} and Charlotte Tibi and Susan Vega and Weakley, {David R.} and Stager, {David R.} and Joost Felius and Clare Dias and Sager, {Debra L.} and Todd Brantley and Robert Hardy and Eileen Birch and Ken Cheng and Richard Hertle and Craig Kollman and Marshalyn Yeargin-Allsopp and Cindy Bachman and Allen Beck",

year = "2010",

month = jan,

doi = "10.1001/archophthalmol.2009.350",

language = "English (US)",

volume = "128",

pages = "21--27",

journal = "Archives of Ophthalmology",

issn = "0003-9950",

publisher = "American Medical Association",

number = "1",

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TY - JOUR

T1 - The infant aphakia treatment study

T2 - Design and clinical measures at enrollment

AU - Lambert, Scott R.

AU - Buckley, Edward G.

AU - Drews-Botsch, Carolyn

AU - DuBois, Lindreth

AU - Hartmann, Eugenie

AU - Lynn, Michael J.

AU - Plager, David A.

AU - Wilson, M. Edward

AU - Bridgman, Betsy

AU - Celano, Marianne

AU - Cleveland, Julia

AU - Cotsonis, George

AU - Freret, Nana

AU - Lu, Lu

AU - Swanson, Seegar

AU - Tutu-Gxashe, Thandeka

AU - Edwards, Clara

AU - Busettini, Claudio

AU - Hayley, Samuel

AU - Everett, Donald F.

AU - Russell, Buddy

AU - Ward, Michael

AU - Bozic, Margaret

AU - VanderVeen, Deborah K.

AU - Mansfield, Theresa A.

AU - Miller, Kathryn Bisceglia

AU - Christiansen, Stephen P.

AU - Bothun, Erick D.

AU - Holleschau, Ann M.

AU - Jedlicka, Jason

AU - Winters, Patricia M.

AU - Traboulsi, Elias I.

AU - Crowe, Susan S.

AU - Cimino, Heather Hasley

AU - Yen, Kimberly G.

AU - Castanes, Maria

AU - Sanchez, Alma

AU - York, Shirley

AU - Wheeler, David T.

AU - Stout, Ann U.

AU - Rauch, Paula

AU - Beaudet, Kimberly

AU - Berg, Pam

AU - Hutchinson, Amy K.

AU - Reeves, Rachel

AU - Shainberg, Marla J.

AU - Freedman, Sharon F.

AU - Duncan, Lois

AU - Phillips, B. W.

AU - Petrowski, John T.

AU - Morrison, David G.

AU - Owings, Sandy

AU - Biernacki, Ron

AU - Franklin, Christine

AU - Neely, Daniel E.

AU - Whitaker, Michele

AU - Bates, Donna

AU - Donaldson, Dana

AU - Kruger, Stacey J.

AU - Tibi, Charlotte

AU - Vega, Susan

AU - Weakley, David R.

AU - Stager, David R.

AU - Felius, Joost

AU - Dias, Clare

AU - Sager, Debra L.

AU - Brantley, Todd

AU - Hardy, Robert

AU - Birch, Eileen

AU - Cheng, Ken

AU - Hertle, Richard

AU - Kollman, Craig

AU - Yeargin-Allsopp, Marshalyn

AU - Bachman, Cindy

AU - Beck, Allen

PY - 2010/1

Y1 - 2010/1

N2 - 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 41/2 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 weeksofageatthetimeofenrollment;32,7weeksto3months ofage;andtheremaining32, morethan3tolessthan7months 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 Identifier: NCT00212134.

AB - 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 41/2 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 weeksofageatthetimeofenrollment;32,7weeksto3months ofage;andtheremaining32, morethan3tolessthan7months 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 Identifier: NCT00212134.

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The infant aphakia treatment study: Design and clinical measures at enrollment

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