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

Scott R. Lambert, Edward G. Buckley, Carolyn Drews-Botsch, Lindreth DuBois, E. Eugenie Hartmann, Michael J. Lynn, David Plager, M. Edward Wilson

Research output: Contribution to journalArticle

112 Citations (Scopus)

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 Identifier: NCT00212134.

Original languageEnglish
Pages (from-to)810-818
Number of pages9
JournalArchives of Ophthalmology
Volume128
Issue number7
DOIs
StatePublished - Jul 2010
Externally publishedYes

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Aphakia
Intraocular Lenses
Contact Lenses
Randomized Controlled Trials
Visual Acuity
Intraocular Lens Implantation
Cataract
Lenses
Outcome Assessment (Health Care)
Clinical Trials
Membranes
Incidence

ASJC Scopus subject areas

  • Ophthalmology

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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. / Lambert, Scott R.; Buckley, Edward G.; Drews-Botsch, Carolyn; DuBois, Lindreth; Hartmann, E. Eugenie; Lynn, Michael J.; Plager, David; Wilson, M. Edward.

In: Archives of Ophthalmology, Vol. 128, No. 7, 07.2010, p. 810-818.

Research output: Contribution to journalArticle

Lambert, Scott R. ; Buckley, Edward G. ; Drews-Botsch, Carolyn ; DuBois, Lindreth ; Hartmann, E. Eugenie ; Lynn, Michael J. ; Plager, David ; Wilson, M. Edward. / 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. In: Archives of Ophthalmology. 2010 ; Vol. 128, No. 7. pp. 810-818.
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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 Identifier: NCT00212134.",
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