Long-term Effect of Intraocular Lens vs Contact Lens Correction After Cataract Surgery During Infancy | Cataract and Other Lens Disorders | JN Learning | AMA Ed Hub [Skip to Content]
[Skip to Content Landing]

Long-term Effect of Intraocular Lens vs Contact Lens Correction on Visual Acuity After Cataract Surgery During InfancyA Randomized Clinical Trial

Educational Objective
To compare long-term visual outcomes with contact lens vs intraocular lens correction following unilateral cataract surgery during infancy.
1 Credit CME
Key Points

Question  Is primary intraocular lens implantation associated with improvements in the long-term visual outcome for infants undergoing unilateral congenital cataract surgery?

Findings  This randomized clinical trial of 114 patients who underwent treatment for unilateral congenital cataract, with or without intraocular lens implantation, between ages 1 and 6 months found that visual acuity at age 10.5 years was not significantly different between the 2 treatment groups.

Meaning  Results of this randomized clinical trial showed that implanting an intraocular lens at the time of cataract surgery extraction was neither beneficial nor detrimental to the visual outcome in children with unilateral congenital cataract.

Abstract

Importance  Although intraocular lenses (IOLs) are often implanted in children, little is known whether primary IOL implantation or aphakia and contact lens correction results in better long-term visual outcomes after unilateral cataract surgery during infancy.

Objective  To compare long-term visual outcomes with contact lens vs IOL correction following unilateral cataract surgery during infancy.

Design, Setting, and Participants  This multicenter randomized clinical trial enrolled 114 infants with a unilateral congenital cataract who underwent cataract surgery with or without primary IOL implantation between 1 and 6 months of age. Data on long-term visual outcomes were collected when the children were age 10.5 years (July 14, 2015, to July 12, 2019) and analyzed from March 30 through August 6, 2019.

Interventions  Intraocular lens implantation at the time of cataract surgery.

Main Outcomes and Measures  Best-corrected visual acuity using the electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) testing protocol. Analysis was performed on an intention-to-treat basis.

Results  Best-corrected visual acuity was measured at age 10.5 years for 110 of the 114 patients (96%) enrolled as infants. The participants included 58 girls (53%) and 52 boys (47%). Overall, 27 of the children (25%) had good (logMAR 0.30 [Snellen equivalent, 20/40] or better) visual acuity in the treated eye (12 [22%] in the IOL group and 15 [27%] in the aphakia group), but 50 children (44%) had a visual acuity of logMAR 1.00 (Snellen equivalent, 20/200) or worse (25 [44%] in the IOL group and 25 [44%] in the aphakia group). The median logMAR acuity in the treated eye was similar in children randomized to receive an IOL at the time of cataract extraction (0.89; interquartile range [IQR], 0.33-1.43 [Snellen equivalent, 20/159]) and those who remained aphakic (0.86; IQR, 0.30-1.46 [Snellen equivalent, 20/145]) (IQR, 0.30-1.46; P = .82). Although the overall difference in median visual acuity between the 2 groups was small, the estimate was imprecise (99% CI for the difference in medians was −0.54 to 0.47).

Conclusions and Relevance  As in previous phases of the study, visual acuity outcomes were highly variable with only 27 children (25%) achieving excellent visual acuity in their treated eye and 50 children (44%) having poor vision in the treated eye. Implanting an IOL at the time of cataract extraction was neither beneficial nor detrimental to the visual outcome.

Trial Registration  ClinicalTrials.gov Identifier: NCT00212134

Sign in to take quiz and track your certificates

Buy This Activity

JN Learning™ is the home for CME and MOC from the JAMA Network. Search by specialty or US state and earn AMA PRA Category 1 CME Credit™ from articles, audio, Clinical Challenges and more. Learn more about CME/MOC

CME Disclosure Statement: Unless noted, all individuals in control of content reported no relevant financial relationships. If applicable, all relevant financial relationships have been mitigated.

Article Information

Accepted for Publication: December 24, 2019.

Corresponding Author: Scott R. Lambert, MD, Department of Ophthalmology, Stanford University School of Medicine, 2452 Watson Ct, Palo Alto, CA 94303 (lambert7@stanford.edu).

Published Online: February 20, 2020. doi:10.1001/jamaophthalmol.2020.0006

Author Contributions: Drs Lambert and Drews-Botsch had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Lambert, DuBois, Hartmann, Drews-Botsch.

Acquisition, analysis, or interpretation of data: All authors.

Drafting of the manuscript: Lambert, DuBois, Hartmann, Drews-Botsch.

Critical revision of the manuscript for important intellectual content: Lambert, Cotsonis, Nizam, Kruger, Hartmann, Weakley, Drews-Botsch.

Statistical analysis: Cotsonis, Nizam, Hartmann, Drews-Botsch.

Obtained funding: Lambert.

Administrative, technical, or material support: Lambert, DuBois, Hartmann, Weakley, Drews-Botsch.

Supervision: Lambert, DuBois.

Conflict of Interest Disclosures: Dr Cotsonis reported grants from Emory University during the conduct of the study. Dr DuBois reported grants from NIH/NEI during the conduct of the study. Dr Nizam reported grants from NIH during the conduct of the study. Dr Drews-Botsch reported grants from NIH/NEI during the conduct of the study. No other disclosures were reported.

Funding/Support: This study was supported by National Eye Institute of the National Institutes of Health, Department of Health and Human Services grants U10 EY13272, U10 EY013287, UG1 EY013272, 1UG1 EY025553; Research to Prevent Blindness, Inc; and the Norm Medow Foundation.

Role of the Funder/Sponsor: The funding organizations had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

The Infant Aphakia Treatment Study Group: Administrative Units and Participating Clinical Centers: Clinical Coordinating Center: Scott R. Lambert, MD (Study Chair); Lindreth DuBois, MEd, MMSc, CO, COMT (National Coordinator): Emory University, Atlanta, Georgia. Data Coordinating Center: Michael Lynn MS (director), Betsy Bridgman, BS; Marianne Celano, PhD; Julia Cleveland, MSPH; George Cotsonis, MS; Carey Drews-Botsch, PhD; Nana Freret, MSN; Lu Lu, MS; Seegar Swanson; Thandeka Tutu-Gxashe, MPH: Emory University, Atlanta, Georgia. Visual Acuity Testing Center: E. Eugenie Hartmann, PhD (director); Anna K Carrigan, MPH; Clara Edwards: University of Alabama, Birmingham. Eye Movement Reading Center: Claudio Busettini, PhD; Samuel Hayley; Eleanor Lewis, Alicia Kindred, Joost Felius, PhD: University of Alabama, Birmingham and Retina Foundation of the Southwest, Dallas, Texas. Steering Committee: Scott R. Lambert, MD; Edward G. Buckley, MD; David A. Plager, MD; M. Edward Wilson, MD; Michael Lynn, MS; Lindreth DuBois, MEd, MMSc; Carolyn Drews-Botsch, PhD; E. Eugenie Hartmann, PhD; Donald F. Everett, MA. Rotating: Joost Felius, PhD; Margaret Bozic, CCRC, COA; Ann Holleschau, BA. Contact Lens Committee: Buddy Russell, COMT; Michael Ward, MMSc. Participating Clinical Centers (in order by the number of patients enrolled): M. Edward Wilson, MD; Margaret Bozic, CCRC, COA; Carol Bradham, COA, CCRC: Medical University of South Carolina; Charleston, South Carolina (14); Deborah K. Vanderveen, MD; Theresa A. Mansfield, RN; Kathryn Bisceglia Miller, OD: Harvard University; Boston, Massachusetts (14); Stephen P. Christiansen, MD; Erick D. Bothun, MD; Ann Holleschau, B.A.; Jason Jedlicka, OD; Patricia Winters, OD; Jacob Lang, OD: University of Minnesota; Minneapolis, Minnesota (13); Elias I. Traboulsi, MD; Susan Crowe, BS, COT; Heather Hasley Cimino, OD: Cleveland Clinic; Cleveland, Ohio (10); Faruk Orge, MD; Megin Kwiatkowski; Beth Colon: Case Western Reserve University, Cleveland, Ohio; Kimberly G. Yen, MD; Maria Castanes, MPH; Alma Sanchez, COA; Shirley York, OD; Stacy Malone, COA; Margaret Olfson: Baylor College of Medicine; Houston, Texas (10); David T Wheeler, MD; Ann U. Stout, MD; Paula Rauch, OT, CRC; Kimberly Beaudet, CO, COMT; Pam Berg, CO, COMT: Oregon Health and Science University, Portland, Oregon (9); Scott R. Lambert, MD; Amy K. Hutchinson, MD; Lindreth Dubois, MEd, MMSc, CO, COMT; Rachel Robb, MMSc, CO, COMT; Marla J. Shainberg, CO: Emory University; Atlanta, Georgia (9); Edward G. Buckley, MD; Sharon F. Freedman, MD; Lois Duncan, BS, CO, COMT; B. W. Phillips, FCLSA; John T. Petrowski, OD: Duke University; Durham, North Carolina (8); David Morrison, MD; Sandy Owings COA, CCRP; Ron Biernacki, CO, COMT; Christine Franklin, COT: Vanderbilt University: Nashville, Tennessee (8); David A. Plager, MD; Daniel E. Neely, MD; Michele Whitaker, COT; Donna Bates, COA; Dana Donaldson, OD: Indiana University, Indianapolis, Indiana (7); Stacey Kruger, MD; Charlotte Tibi, CO; Susan Vega: Miami Children’s Hospital, Miami, Florida (6); David R. Weakley, MD; David R. Stager Jr MD; Joost Felius, PhD; Clare Dias, CO; Debra L. Sager; Todd Brantley, OD: University of Texas Southwestern; Dallas, Texas (6). Data and Safety Monitoring Committee: Robert Hardy, PhD (chair); Eileen Birch, PhD; Ken Cheng, MD; Richard Hertle, MD; Craig Kollman, PhD; Marshalyn Yeargin-Allsopp, MD (resigned); Cyd McDowell (deceased); Donald F. Everett, MA. Medical Safety Monitor: Allen Beck, MD.

Data Sharing Statement: See Supplement 2.

Additional Information: The off-label research use of the Acrysof SN60AT and MA60AC intraocular lenses (Alcon Laboratories) was covered by US Food and Drug Administration investigational device exemption G020021.

References
1.
Solebo  AL , Russell-Eggitt  I , Cumberland  PM , Rahi  JS ; British Isles Congenital Cataract Interest Group.  Risks and outcomes associated with primary intraocular lens implantation in children under 2 years of age: the IoLunder2 cohort study.   Br J Ophthalmol. 2015;99(11):1471-1476. doi:10.1136/bjophthalmol-2014-306394 PubMedGoogle ScholarCrossref
2.
Solebo  AL , Cumberland  P , Rahi  JS ; British Isles Congenital Cataract Interest Group.  5-Year outcomes after primary intraocular lens implantation in children aged 2 years or younger with congenital or infantile cataract: findings from the IoLunder2 prospective inception cohort study.   Lancet Child Adolesc Health. 2018;2(12):863-871. doi:10.1016/S2352-4642(18)30317-1 PubMedGoogle ScholarCrossref
3.
Lambert  SR , Aakalu  VK , Hutchinson  AK ,  et al.  Intraocular lens implantation during early childhood: a report by the American Academy of Ophthalmology.   Ophthalmology. 2019;126(10):1454-1461. doi:10.1016/j.ophtha.2019.05.009 PubMedGoogle ScholarCrossref
4.
Koo  EB , VanderVeen  DK , Lambert  SR .  Global practice patterns in the management of infantile cataracts.   Eye Contact Lens. 2018;44(suppl 2):S292-S296. doi:10.1097/ICL.0000000000000461 PubMedGoogle ScholarCrossref
5.
Bothun  ED , Wilson  ME , Traboulsi  EI ,  et al; Toddler Aphakia and Pseudophakia Study Group (TAPS).  Outcomes of unilateral cataracts in infants and toddlers 7 to 24 months of age: Toddler Aphakia and Pseudophakia Study (TAPS).   Ophthalmology. 2019;126(8):1189-1195. doi:10.1016/j.ophtha.2019.03.011 PubMedGoogle ScholarCrossref
6.
Lambert  SR , Buckley  EG , Drews-Botsch  C ,  et al; Infant Aphakia Treatment Study Group.  The infant aphakia treatment study: design and clinical measures at enrollment.   Arch Ophthalmol. 2010;128(1):21-27. doi:10.1001/archophthalmol.2009.350 PubMedGoogle ScholarCrossref
7.
Lambert  SR , Buckley  EG , Drews-Botsch  C ,  et al; Infant Aphakia Treatment Study Group.  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.   Arch Ophthalmol. 2010;128(7):810-818. doi:10.1001/archophthalmol.2010.101 PubMedGoogle ScholarCrossref
8.
Hartmann  EE , Lynn  MJ , Lambert  SR ; Infant Aphakia Treatment Study Group.  Baseline characteristics of the infant aphakia treatment study population: predicting recognition acuity at 4.5 years of age.   Invest Ophthalmol Vis Sci. 2014;56(1):388-395. doi:10.1167/iovs.14-15464 PubMedGoogle ScholarCrossref
9.
Holmes  JM , Melia  M , Bradfield  YS , Cruz  OA , Forbes  B ; Pediatric Eye Disease Investigator Group.  Factors associated with recurrence of amblyopia on cessation of patching.   Ophthalmology. 2007;114(8):1427-1432. doi:10.1016/j.ophtha.2006.11.023 PubMedGoogle ScholarCrossref
10.
Holmes  JM , Beck  RW , Kraker  RT ,  et al; Pediatric Eye Disease Investigator Group.  Risk of amblyopia recurrence after cessation of treatment.   J AAPOS. 2004;8(5):420-428. doi:10.1016/S1091-8531(04)00161-2 PubMedGoogle ScholarCrossref
11.
Tailor  V , Bossi  M , Greenwood  JA , Dahlmann-Noor  A .  Childhood amblyopia: current management and new trends.   Br Med Bull. 2016;119(1):75-86. doi:10.1093/bmb/ldw030 PubMedGoogle ScholarCrossref
12.
Lambert  SR , Lynn  MJ , Hartmann  EE ,  et al; Infant Aphakia Treatment Study Group.  Comparison of contact lens and intraocular lens correction of monocular aphakia during infancy: a randomized clinical trial of HOTV optotype acuity at age 4.5 years and clinical findings at age 5 years.   JAMA Ophthalmol. 2014;132(6):676-682. doi:10.1001/jamaophthalmol.2014.531 PubMedGoogle ScholarCrossref
13.
World Medical Association.  World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects.   JAMA. 2013;310(20):2191-2194. doi:10.1001/jama.2013.281053PubMedGoogle ScholarCrossref
14.
Beck  RW , Moke  PS , Turpin  AH ,  et al.  A computerized method of visual acuity testing: adaptation of the early treatment of diabetic retinopathy study testing protocol.   Am J Ophthalmol. 2003;135(2):194-205. doi:10.1016/S0002-9394(02)01825-1 PubMedGoogle ScholarCrossref
15.
Roberts  MF , Fishman  GA , Roberts  DK ,  et al.  Retrospective, longitudinal, and cross sectional study of visual acuity impairment in choroideraemia.   Br J Ophthalmol. 2002;86(6):658-662. doi:10.1136/bjo.86.6.658 PubMedGoogle ScholarCrossref
16.
Drews-Botsch  CD , Hartmann  EE , Celano  M ; Infant Aphakia Treatment Study Group.  Predictors of adherence to occlusion therapy 3 months after cataract extraction in the Infant Aphakia Treatment Study.   J AAPOS. 2012;16(2):150-155. doi:10.1016/j.jaapos.2011.12.149 PubMedGoogle ScholarCrossref
17.
Cromelin  CH , Drews-Botsch  C , Russell  B , Lambert  SR ; Infant Aphakia Treatment Study Group.  Association of contact lens adherence with visual outcome in the infant aphakia treatment study: a secondary analysis of a randomized clinical trial.   JAMA Ophthalmol. 2018;136(3):279-285. doi:10.1001/jamaophthalmol.2017.6691 PubMedGoogle ScholarCrossref
18.
Lambert  SR , DuBois  L , Cotsonis  G , Hartmann  EE , Drews-Botsch  C .  Factors associated with stereopsis and a good visual acuity outcome among children in the Infant Aphakia Treatment Study.   Eye (Lond). 2016;30(9):1221-1228. doi:10.1038/eye.2016.164 PubMedGoogle ScholarCrossref
19.
Plager  DA , Lynn  MJ , Buckley  EG , Wilson  ME , Lambert  SR ; Infant Aphakia Treatment Study Group.  Complications in the first 5 years following cataract surgery in infants with and without intraocular lens implantation in the Infant Aphakia Treatment Study.   Am J Ophthalmol. 2014;158(5):892-898. doi:10.1016/j.ajo.2014.07.031 PubMedGoogle ScholarCrossref
20.
Hensch  TK , Quinlan  EM .  Critical periods in amblyopia.   Vis Neurosci. 2018;35:E014. doi:10.1017/S0952523817000219 PubMedGoogle Scholar
21.
Plager  DA , Lynn  MJ , Buckley  EG , Wilson  ME , Lambert  SR ; Infant Aphakia Treatment Study Group.  Complications, adverse events, and additional intraocular surgery 1 year after cataract surgery in the infant Aphakia Treatment Study.   Ophthalmology. 2011;118(12):2330-2334. doi:10.1016/j.ophtha.2011.06.017 PubMedGoogle ScholarCrossref
22.
Kruger  SJ , DuBois  L , Becker  ER ,  et al; Infant Aphakia Treatment Study Group.  Cost of intraocular lens versus contact lens treatment after unilateral congenital cataract surgery in the infant aphakia treatment study at age 5 years.   Ophthalmology. 2015;122(2):288-292. doi:10.1016/j.ophtha.2014.08.037 PubMedGoogle ScholarCrossref
23.
Kruger  SJ , Vanderveen  DK , Freedman  SF , Bothun  E , Drews-Botsch  CD , Lambert  SR ; Infant Aphakia Study Group.  Third-party coverage for aphakic contact lenses for children.   Transl Vis Sci Technol. 2019;8(3):41. doi:10.1167/tvst.8.3.41 PubMedGoogle ScholarCrossref
24.
Russell  B , Ward  MA , Lynn  M , Dubois  L , Lambert  SR ; Infant Aphakia Treatment Study Group.  The infant aphakia treatment study contact lens experience: one-year outcomes.   Eye Contact Lens. 2012;38(4):234-239. doi:10.1097/ICL.0b013e3182562dc0 PubMedGoogle ScholarCrossref
25.
Russell  B , DuBois  L , Lynn  M , Ward  MA , Lambert  SR ; Infant Aphakia Treatment Study Group.  The Infant Aphakia Treatment Study Contact Lens Experience to Age 5 Years.   Eye Contact Lens. 2017;43(6):352-357. doi:10.1097/ICL.0000000000000291 PubMedGoogle ScholarCrossref
26.
Gurland  JE .  Use of silicone lenses in infants and children.   Ophthalmology. 1979;86(9):1599-1604. doi:10.1016/S0161-6420(79)35359-3 PubMedGoogle ScholarCrossref
27.
Nelson  LB , Cutler  SI , Calhoun  JH , Wilson  TW , Harley  RD .  Silsoft extended wear contact lenses in pediatric aphakia.   Ophthalmology. 1985;92(11):1529-1531. doi:10.1016/S0161-6420(85)33825-3 PubMedGoogle ScholarCrossref
28.
Lambert  SR , Kraker  RT , Pineles  SL ,  et al.  Contact Lens Correction of Aphakia in Children: A Report by the American Academy of Ophthalmology.   Ophthalmology. 2018;125(9):1452-1458. doi:10.1016/j.ophtha.2018.03.014 PubMedGoogle ScholarCrossref
29.
Amos  CF , Lambert  SR , Ward  MA .  Rigid gas permeable contact lens correction of aphakia following congenital cataract removal during infancy.   J Pediatr Ophthalmol Strabismus. 1992;29(4):243-245.PubMedGoogle Scholar
30.
Ruth  AL , Lambert  SR .  Amblyopia in the phakic eye after unilateral congenital cataract extraction.   J AAPOS. 2006;10(6):587-588. doi:10.1016/j.jaapos.2006.08.003 PubMedGoogle ScholarCrossref
If you are not a JN Learning subscriber, you can either:
Subscribe to JN Learning for one year
Buy this activity
jn-learning_Modal_Multimedia_LoginSubscribe_Purchase
Close
If you are not a JN Learning subscriber, you can either:
Subscribe to JN Learning for one year
Buy this activity
jn-learning_Modal_Multimedia_LoginSubscribe_Purchase
Close
With a personal account, you can:
  • Access free activities and track your credits
  • Personalize content alerts
  • Customize your interests
  • Fully personalize your learning experience
Education Center Collection Sign In Modal Right
Close

Name Your Search

Save Search
Close
With a personal account, you can:
  • Track your credits
  • Personalize content alerts
  • Customize your interests
  • Fully personalize your learning experience
jn-learning_Modal_SaveSearch_NoAccess_Purchase
Close

Lookup An Activity

or

Close

My Saved Searches

You currently have no searches saved.

Close
With a personal account, you can:
  • Access free activities and track your credits
  • Personalize content alerts
  • Customize your interests
  • Fully personalize your learning experience
Education Center Collection Sign In Modal Right
Close