Infant Aphakia Treatment Study (IATS)

NCT00212134 | Completed Results DMC

• 5 other identifiers: IRB00024837U10EY013272EY013287EY013272NEI-108
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 13

Brief Summary

The primary purpose is to determine whether infants with a unilateral congenital cataract are more likely to develop better vision following cataract extraction surgery if they undergo primary implantation of an intraocular lens or if they are treated primarily with a contact lens. In addition, the study will compare the occurrence of postoperative complications and the degree of parental stress between the two treatments.

Conditions

Congenital Cataract

Keywords

cataract surgery; intraocular lens; contact lens; infants; aphakia

Outcome Measures

Primary Outcomes (3)

• Visual Acuity

  Visual acuity was measured by standard objective testing procedures at 12 months of age. Monocular grating acuity was assessed by the traveling examiner with the Teller Acuity Cards. This test uses cards with black-on-white lines of varying widths and a set distance apart in a square with fixed dimensions, so the thinner the lines, the more there will be on any given card (cycles/cm). The ability to see thinner lines indicates better vision. The cards with lines are presented simultaneously with a gray card and the child's visual attention is noted. It is presumed that the child will preferentially look at the card with the stripes as it is more interesting. When the lines are too thin and close together so as to be indistinguishable from the gray card, no preferential looking will be noted. The card with the thinnest lines that the child will look at is recorded as the best visual acuity in logMAR units.

  Phase 1 - Age 12 months

• Visual Acuity - Subjective Assessment at Age 4.5 Years.

  Visual acuity estimates were standardized by using the Electronic Visual Acuity Tester (EVAT) at each clinical site. The IATS patients were tested at 4.5 years of age allowing the use of the HOTV recognition acuity test. The Amblyopia Treatment Study protocol for presentation and determination of best corrected visual acuity was followed. Monocular visual acuity was evaluated using single letter optotypes with surround bars presented on the EVAT. The staircase procedure of the ATS projects was followed as this has documented success and reliability with this age group. In order to familiarize the subjects with the HOTV matching test, this test was introduced at the 4.0 year visit and the 4.25 year visit by experienced site personnel.

  Phase 2 - Age 4.5 Years

• Visual Acuity - Subjective Assessment at Age 10 Years.

  Visual acuity estimates were standardized by using the Electronic Visual Acuity Tester (EVAT) at each clinical site. The IATS patients were tested at 10.5 years of age allowing the use of the electronic early treatment diabetic retinopathy study (E-ETDRS) testing protocol. LogMAR typically ranges from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision).

  Phase 3 - Age 10.5 Years

Secondary Outcomes (5)

• Percent of Patients With 1 or More Intraoperative Complications at Cataract Surgery

  Cataract surgery immediately after enrollment

• Percent of Patients With 1 or More Adverse Events

  Study enrollment to age 5 years

• Parenting Stress

  Phase 1 - 3 months post surgery

• Adherence to Occlusion Therapy

  Phase 1 - 12 months follow-up

• Parenting Stress

  Phase 1 - Age 12 Months

Study Arms (2)

aphakic contact lens

ACTIVE COMPARATOR

Contact lens correction of aphakia INTERVENTION: use of an external contact lens (CL) to correct the large hyperopic refractive error produced by surgically extracting the natural cataractous lens. As the eye grows, the refractive error changes and the power of the CL can be changed accordingly.

Device: Contact lens correction of aphakia

aphakic intraocular lens

EXPERIMENTAL

Intraocular lens implantation INTERVENTION: At the time of surgery to remove the cataractous natural lens, an intraocular lens was implanted to correct the large hyperopic refractive error induced by the cataract surgery.

Device: Intraocular lens implantation

Interventions

Contact lens correction of aphakia DEVICE

optical correction of infant surgical aphakia with Contact lens

Also known as: Silsoft aphakic contact lens, rigid gas permeable contact lens

aphakic contact lens

Intraocular lens implantation DEVICE

optical correction of surgical aphakia with intraocular lens

Also known as: Alcon SA60AT, Alcon MA60AC

aphakic intraocular lens

Eligibility Criteria

• Age: 28 Days - 210 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Visually significant unilateral congenital cataract (central opacity equal to or greater than 3 mm in size).
• Cataract surgery performed when the patient is 28 to 210 days of age and at least 41 post-conceptional weeks.

You may not qualify if:

• The cataract is known to be acquired from trauma or as a side-effect of a treatment administered postnatally such as radiation or medical therapy.
• A corneal diameter less than 9 mm measured in the horizontal meridian using calipers.
• An intraocular pressure of 25 mm Hg or greater in the affected eye measured with a Perkins tonometer, tonopen, or pneumatonometer.
• Persistent fetal vasculature (PFV) causing stretching of the ciliary processes or a tractional retinal detachment.
• Active uveitis or signs suggestive of a previous episode of uveitis such as posterior synechiae or keratic precipitates.
• The child is the product of a pre-term pregnancy (\<36 gestational weeks). Screening for prematurity will be based on the clinician's best assessment of gestational age. If a physician is uncertain regarding the gestational age, review of medical records or contact with the pediatrician and/or obstetrician should be used to confirm gestational age at delivery. Unless a clinician is uncertain as to whether a child was born at less than 36 weeks or not, confirmation of gestational age via medical record review may be delayed until after enrollment.
• Retinal disease that may limit the visual potential of the eye such as retinopathy of prematurity.
• Previous intraocular surgery.
• Optic nerve disease that may limit the visual potential of the eye such as optic nerve hypoplasia.
• The fellow eye has ocular disease that might reduce its visual potential.
• The child has a medical condition known to limit the ability to obtain visual acuity at 12 months or 4 years of age.
• Refusal by the Parent/Legal Guardian to sign an informed consent or to be randomized to one of the two treatment groups.
• Follow-up of the child is not feasible because the child would not be able to return for regular follow-up examinations and the outcome assessments (e.g. transportation difficulties, relocation, etc.).

Sponsors & Collaborators

• Stanford University: lead
• National Eye Institute (NEI): collaborator
• Alcon Research: collaborator
• Bausch & Lomb Incorporated: collaborator
• BSN-JOBST Inc.: collaborator
• Eye Care and Cure: collaborator

Study Sites (13)

Stanford University

Palo Alto, California, 94303, United States

Location

Miami Children's Hospital

Miami, Florida, 33155, United States

Location

Emory Eye Center

Atlanta, Georgia, 30322, United States

Location

Indiana University Medical Center

Indianapolis, Indiana, 46202-5175, United States

Location

Harvard University

Boston, Massachusetts, 02115, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455-0501, United States

Location

Duke University Eye Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239-4197, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425-2236, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232-8808, United States

Location

Pediatric Ophthalmology, P.A.

Dallas, Texas, 75225, United States

Location

Baylor University

Houston, Texas, 77030, United States

Location

Related Publications (72)

• Bothun ED, Lynn MJ, Lambert SR. Author reply: To PMID 23419803. Ophthalmology. 2014 Oct;121(10):e53. doi: 10.1016/j.ophtha.2014.05.011. Epub 2014 Jun 6. No abstract available.

  PMID: 24909820 RESULT

• Traboulsi EI, Vanderveen D, Morrison D, Drews-Botsch CD, Lambert SR; Infant Aphakia Treatment Study Group. Associated systemic and ocular disorders in patients with congenital unilateral cataracts: the Infant Aphakia Treatment Study experience. Eye (Lond). 2016 Sep;30(9):1170-4. doi: 10.1038/eye.2016.124. Epub 2016 Jun 17.

  PMID: 27315350 RESULT

• Drews-Botsch C, Celano M, Cotsonis G, Hartmann EE, Lambert SR; Infant Aphakia Treatment Study Group. Association Between Occlusion Therapy and Optotype Visual Acuity in Children Using Data From the Infant Aphakia Treatment Study: A Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2016 Aug 1;134(8):863-9. doi: 10.1001/jamaophthalmol.2016.1365.

  PMID: 27228110 RESULT

• Lambert SR, Plager DA, Lynn MJ, Wilson ME. Visual outcome following the reduction or cessation of patching therapy after early unilateral cataract surgery. Arch Ophthalmol. 2008 Aug;126(8):1071-4. doi: 10.1001/archopht.126.8.1071.

  PMID: 18695101 RESULT

• Infant Aphakia Treatment Study Group; Lambert SR, Buckley EG, Drews-Botsch C, DuBois L, Hartmann E, Lynn MJ, Plager DA, Wilson ME. The infant aphakia treatment study: design and clinical measures at enrollment. Arch Ophthalmol. 2010 Jan;128(1):21-7. doi: 10.1001/archophthalmol.2009.350.

  PMID: 20065212 RESULT

• Infant Aphakia Treatment Study Group; Lambert SR, Buckley EG, Drews-Botsch C, DuBois L, Hartmann EE, Lynn MJ, Plager DA, Wilson ME. 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 Jul;128(7):810-8. doi: 10.1001/archophthalmol.2010.101. Epub 2010 May 10.

  PMID: 20457949 RESULT

• 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 Dec;118(12):2330-4. doi: 10.1016/j.ophtha.2011.06.017. Epub 2011 Sep 16.

  PMID: 21925737 RESULT

• Morrison DG, Wilson ME, Trivedi RH, Lambert SR, Lynn MJ; Infant Aphakia Treatment Study Group. Infant Aphakia Treatment Study: effects of persistent fetal vasculature on outcome at 1 year of age. J AAPOS. 2011 Oct;15(5):427-31. doi: 10.1016/j.jaapos.2011.06.004.

  PMID: 22108353 RESULT

• Wilson ME, Trivedi RH, Morrison DG, Lambert SR, Buckley EG, Plager DA, Lynn MJ; Infant Aphakia Treatment Study Group. The Infant Aphakia Treatment Study: evaluation of cataract morphology in eyes with monocular cataracts. J AAPOS. 2011 Oct;15(5):421-6. doi: 10.1016/j.jaapos.2011.05.016.

  PMID: 22108352 RESULT

• 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 Apr;16(2):150-5. doi: 10.1016/j.jaapos.2011.12.149.

  PMID: 22525171 RESULT

• Beck AD, Freedman SF, Lynn MJ, Bothun E, Neely DE, Lambert SR; Infant Aphakia Treatment Study Group. Glaucoma-related adverse events in the Infant Aphakia Treatment Study: 1-year results. Arch Ophthalmol. 2012 Mar;130(3):300-5. doi: 10.1001/archophthalmol.2011.347. Epub 2011 Nov 14.

  PMID: 22084157 RESULT

• VanderVeen DK, Nizam A, Lynn MJ, Bothun ED, McClatchey SK, Weakley DR, DuBois LG, Lambert SR; Infant Aphakia Treatment Study Group. Predictability of intraocular lens calculation and early refractive status: the Infant Aphakia Treatment Study. Arch Ophthalmol. 2012 Mar;130(3):293-9. doi: 10.1001/archophthalmol.2011.358.

  PMID: 22411658 RESULT

• 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 Jul;38(4):234-9. doi: 10.1097/ICL.0b013e3182562dc0.

  PMID: 22669008 RESULT

• Lambert SR, Purohit A, Superak HM, Lynn MJ, Beck AD. Long-term risk of glaucoma after congenital cataract surgery. Am J Ophthalmol. 2013 Aug;156(2):355-361.e2. doi: 10.1016/j.ajo.2013.03.013. Epub 2013 Apr 30.

  PMID: 23639132 RESULT

• Carrigan AK, DuBois LG, Becker ER, Lambert SR; Infant Aphakia Treatment Study Group. Cost of intraocular lens versus contact lens treatment after unilateral congenital cataract surgery: retrospective analysis at age 1 year. Ophthalmology. 2013 Jan;120(1):14-9. doi: 10.1016/j.ophtha.2012.07.049. Epub 2012 Oct 6.

  PMID: 23047003 RESULT

• Trivedi RH, Lambert SR, Lynn MJ, Wilson ME; Infant Aphakia Treatment Study Group. The role of preoperative biometry in selecting initial contact lens power in the Infant Aphakia Treatment Study. J AAPOS. 2014 Jun;18(3):251-4. doi: 10.1016/j.jaapos.2014.01.012.

  PMID: 24924278 RESULT

• Vanderveen DK, Trivedi RH, Nizam A, Lynn MJ, Lambert SR; Infant Aphakia Treatment Study Group. Predictability of intraocular lens power calculation formulae in infantile eyes with unilateral congenital cataract: results from the Infant Aphakia Treatment Study. Am J Ophthalmol. 2013 Dec;156(6):1252-1260.e2. doi: 10.1016/j.ajo.2013.07.014. Epub 2013 Sep 4.

  PMID: 24011524 RESULT

• Hartmann EE, Stout AU, Lynn MJ, Yen KG, Kruger SJ, Lambert SR; Infant Aphakia Treatment Study Group; Infant Aphakia Treatment Study Group. Stereopsis results at 4.5 years of age in the infant aphakia treatment study. Am J Ophthalmol. 2015 Jan;159(1):64-70.e1-2. doi: 10.1016/j.ajo.2014.09.028. Epub 2014 Sep 28.

  PMID: 25261241 RESULT

• Infant Aphakia Treatment Study Group; Lambert SR, Lynn MJ, Hartmann EE, DuBois L, Drews-Botsch C, Freedman SF, Plager DA, Buckley EG, Wilson ME. 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 Jun;132(6):676-82. doi: 10.1001/jamaophthalmol.2014.531.

  PMID: 24604348 RESULT

• Kruger SJ, DuBois L, Becker ER, Morrison D, Wilson L, Wilson ME Jr, Lambert SR; 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 Feb;122(2):288-92. doi: 10.1016/j.ophtha.2014.08.037. Epub 2014 Oct 29.

  PMID: 25439604 RESULT

• Wall PB, Lee JA, Lynn MJ, Lambert SR, Traboulsi EI; Infant Aphakia Treatment Study Group. The effects of surgical factors on postoperative astigmatism in patients enrolled in the Infant Aphakia Treatment Study (IATS). J AAPOS. 2014 Oct;18(5):441-5. doi: 10.1016/j.jaapos.2014.06.016. Epub 2014 Sep 27.

  PMID: 25266831 RESULT

• Bothun ED, Cleveland J, Lynn MJ, Christiansen SP, Vanderveen DK, Neely DE, Kruger SJ, Lambert SR; Infant Aphakic Treatment Study. One-year strabismus outcomes in the Infant Aphakia Treatment Study. Ophthalmology. 2013 Jun;120(6):1227-31. doi: 10.1016/j.ophtha.2012.11.039. Epub 2013 Feb 16.

  PMID: 23419803 RESULT

• Freedman SF, Lynn MJ, Beck AD, Bothun ED, Orge FH, Lambert SR; Infant Aphakia Treatment Study Group. Glaucoma-Related Adverse Events in the First 5 Years After Unilateral Cataract Removal in the Infant Aphakia Treatment Study. JAMA Ophthalmol. 2015 Aug;133(8):907-14. doi: 10.1001/jamaophthalmol.2015.1329.

  PMID: 25996491 RESULT

• 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 Nov;158(5):892-8. doi: 10.1016/j.ajo.2014.07.031. Epub 2014 Jul 29.

  PMID: 25077835 RESULT

• Morrison DG, Lynn MJ, Freedman SF, Orge FH, Lambert SR; Infant Aphakia Treatment Study Group. Corneal Changes in Children after Unilateral Cataract Surgery in the Infant Aphakia Treatment Study. Ophthalmology. 2015 Nov;122(11):2186-92. doi: 10.1016/j.ophtha.2015.07.011. Epub 2015 Aug 11.

  PMID: 26271843 RESULT

• VanderVeen DK, Trivedi RH, Nizam A, Lynn MJ, Lambert SR. Reply: To PMID 24011524. Am J Ophthalmol. 2014 Jun;157(6):1332-3. doi: 10.1016/j.ajo.2014.02.053. No abstract available.

  PMID: 24881851 RESULT

• Kumar P, Lambert SR. Evaluating the evidence for and against the use of IOLs in infants and young children. Expert Rev Med Devices. 2016;13(4):381-9. doi: 10.1586/17434440.2016.1153967. Epub 2016 Feb 29.

  PMID: 26878234 RESULT

• Bothun ED, Lynn MJ, Christiansen SP, Neely DE, Vanderveen DK, Kruger SJ, Lambert SR; Infant Aphakia Treatment Study. Sensorimotor outcomes by age 5 years after monocular cataract surgery in the Infant Aphakia Treatment Study (IATS). J AAPOS. 2016 Feb;20(1):49-53. doi: 10.1016/j.jaapos.2015.11.002.

  PMID: 26917072 RESULT

• Celano M, Hartmann EE, DuBois LG, Drews-Botsch C; Infant Aphakia Treatment Study Group. Motor skills of children with unilateral visual impairment in the Infant Aphakia Treatment Study. Dev Med Child Neurol. 2016 Feb;58(2):154-9. doi: 10.1111/dmcn.12832. Epub 2015 Jun 17.

  PMID: 26084944 RESULT

• Lambert SR, Plager DA, Buckley EG, Wilson ME, DuBois L, Drews-Botsch CD, Hartmann EE, Lynn MJ; Infant Aphakia Treatment Study Group. The Infant Aphakia Treatment Study: further on intra- and postoperative complications in the intraocular lens group. J AAPOS. 2015 Apr;19(2):101-3. doi: 10.1016/j.jaapos.2015.01.012. No abstract available.

  PMID: 25892038 RESULT

• Lambert SR, Lynn MJ, Hartmann EE; Infant Aphakia Treatment Study Group. In reply. JAMA Ophthalmol. 2014 Dec;132(12):1492-3. doi: 10.1001/jamaophthalmol.2014.3542. No abstract available.

  PMID: 25256439 RESULT

• Celano M, Hartmann EE, Drews-Botsch CD; Infant Aphakia Treatment Study Group. Parenting stress in the infant aphakia treatment study. J Pediatr Psychol. 2013 Jun;38(5):484-93. doi: 10.1093/jpepsy/jst009. Epub 2013 Mar 9.

  PMID: 23475835 RESULT

• Lenhart PD, Courtright P, Wilson ME, Lewallen S, Taylor DS, Ventura MC, Bowman R, Woodward L, Ditta LC, Kruger S, Haddad D, El Shakankiri N, Rai SK, Bailey T, Lambert SR. Global challenges in the management of congenital cataract: proceedings of the 4th International Congenital Cataract Symposium held on March 7, 2014, New York, New York. J AAPOS. 2015 Apr;19(2):e1-8. doi: 10.1016/j.jaapos.2015.01.013.

  PMID: 25892047 RESULT

• Nguyen M, Shainberg M, Beck AD, Lambert SR. Structural changes of the anterior chamber following cataract surgery during infancy. J Cataract Refract Surg. 2015 Aug;41(8):1784-6. doi: 10.1016/j.jcrs.2015.07.001. No abstract available.

  PMID: 26432141 RESULT

• 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 Nov;43(6):352-357. doi: 10.1097/ICL.0000000000000291.

  PMID: 27466719 RESULT

• Lambert SR. The timing of surgery for congenital cataracts: Minimizing the risk of glaucoma following cataract surgery while optimizing the visual outcome. J AAPOS. 2016 Jun;20(3):191-2. doi: 10.1016/j.jaapos.2016.04.003. Epub 2016 May 11. No abstract available.

  PMID: 27180288 RESULT

• Celano M, Cotsonis GA, Hartmann EE, Drews-Botsch C; Infant Aphakia Treatment Study Group. Behaviors of children with unilateral vision impairment in the Infant Aphakia Treatment Study. J AAPOS. 2016 Aug;20(4):320-5. doi: 10.1016/j.jaapos.2016.04.008. Epub 2016 Jul 14.

  PMID: 27424046 RESULT

• Drews-Botsch C, Cotsonis G, Celano M, Lambert SR. Assessment of Adherence to Visual Correction and Occlusion Therapy in the Infant Aphakia Treatment Study. Contemp Clin Trials Commun. 2016 Aug 15;3:158-166. doi: 10.1016/j.conctc.2016.05.009. Epub 2016 May 30.

  PMID: 27981259 RESULT

• 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 Sep;30(9):1221-8. doi: 10.1038/eye.2016.164. Epub 2016 Jul 29.

  PMID: 27472216 RESULT

• Bothun ED, Lynn MJ, Christiansen SP, Kruger SJ, Vanderveen DK, Neely DE, Lambert SR; Infant Aphakic Treatment Study. Strabismus surgery outcomes in the Infant Aphakia Treatment Study (IATS) at age 5 years. J AAPOS. 2016 Dec;20(6):501-505. doi: 10.1016/j.jaapos.2016.09.014. Epub 2016 Nov 2.

  PMID: 27815186 RESULT

• Lambert SR, Cotsonis G, DuBois L, Wilson ME, Plager DA, Buckley EG, McClatchey SK; Infant Aphakia Treatment Study Group. Comparison of the rate of refractive growth in aphakic eyes versus pseudophakic eyes in the Infant Aphakia Treatment Study. J Cataract Refract Surg. 2016 Dec;42(12):1768-1773. doi: 10.1016/j.jcrs.2016.09.021.

  PMID: 28007108 RESULT

• Cooke DL. Predictability of intraocular lens power calculation formulae in infantile eyes with unilateral congenital cataract: results from the infant aphakia treatment study. Am J Ophthalmol. 2014 Jun;157(6):1332. doi: 10.1016/j.ajo.2014.02.051. No abstract available.

  PMID: 24881852 RESULT

• Drews-Botsch CD, Celano M, Kruger S, Hartmann EE; Infant Aphakia Treatment Study. Adherence to occlusion therapy in the first six months of follow-up and visual acuity among participants in the Infant Aphakia Treatment Study (IATS). Invest Ophthalmol Vis Sci. 2012 Jun 5;53(7):3368-75. doi: 10.1167/iovs.11-8457.

  PMID: 22491410 RESULT

• Felius J, Busettini C, Lynn MJ, Hartmann EE, Lambert SR; Infant Aphakia Treatment Study Group. Nystagmus and related fixation instabilities following extraction of unilateral infantile cataract in the Infant Aphakia Treatment Study (IATS). Invest Ophthalmol Vis Sci. 2014 Aug 5;55(8):5332-7. doi: 10.1167/iovs.14-14710.

  PMID: 25097243 RESULT

• Lambert SR, Lynn MJ, DuBois LG, Cotsonis GA, Hartmann EE, Wilson ME; Infant Aphakia Treatment Study Groups. Axial elongation following cataract surgery during the first year of life in the infant Aphakia Treatment Study. Invest Ophthalmol Vis Sci. 2012 Nov 7;53(12):7539-45. doi: 10.1167/iovs.12-10285.

  PMID: 23074203 RESULT

• Wilson ME, Trivedi RH, Weakley DR Jr, Cotsonis GA, Lambert SR; Infant Aphakia Treatment Study Group. Globe Axial Length Growth at Age 5 Years in the Infant Aphakia Treatment Study. Ophthalmology. 2017 May;124(5):730-733. doi: 10.1016/j.ophtha.2017.01.010. Epub 2017 Feb 10.

  PMID: 28196730 RESULT

• Weakley DR Jr, Lynn MJ, Dubois L, Cotsonis G, Wilson ME, Buckley EG, Plager DA, Lambert SR; Infant Aphakia Treatment Study Group. Myopic Shift 5 Years after Intraocular Lens Implantation in the Infant Aphakia Treatment Study. Ophthalmology. 2017 Jun;124(6):822-827. doi: 10.1016/j.ophtha.2016.12.040. Epub 2017 Feb 16.

  PMID: 28215452 RESULT

• Plager DA, Lynn MJ, Lambert SR, Buckley EG, Wilson ME; Infant Aphakia Treatment Study Group. Reply: To PMID 25077835. Am J Ophthalmol. 2014 Dec;158(6):1361-2. doi: 10.1016/j.ajo.2014.09.019. Epub 2014 Nov 18. No abstract available.

  PMID: 25457713 RESULT

• Weakley D, Cotsonis G, Wilson ME, Plager DA, Buckley EG, Lambert SR; Infant Aphakia Treatment Study Group. Anisometropia at Age 5 Years After Unilateral Intraocular Lens Implantation During Infancy in the Infant Aphakia Treatment Study. Am J Ophthalmol. 2017 Aug;180:1-7. doi: 10.1016/j.ajo.2017.05.008. Epub 2017 May 17.

  PMID: 28526552 RESULT

• Traboulsi EI, Freedman SF, Wilson ME Jr, Lambert SR; Infant Aphakia Treatment Study Group. Cataract morphology and risk for glaucoma after cataract surgery in infants with unilateral congenital cataract. J Cataract Refract Surg. 2017 Dec;43(12):1611-1612. doi: 10.1016/j.jcrs.2017.10.032. No abstract available.

  PMID: 29335108 RESULT

• Koo EB, VanderVeen DK, Lambert SR. Global Practice Patterns in the Management of Infantile Cataracts. Eye Contact Lens. 2018 Nov;44 Suppl 2(Suppl 2):S292-S296. doi: 10.1097/ICL.0000000000000461.

  PMID: 29369235 RESULT

• 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 Mar 1;136(3):279-285. doi: 10.1001/jamaophthalmol.2017.6691.

  PMID: 29423513 RESULT

• Weakley DR Jr, Lynn MJ, Dubois L, Cotsonis G, Wilson ME, Buckley EG, Plager DA, Lambert SR; Infant Aphakia Treatment Study Group. Reply. Ophthalmology. 2018 Oct;125(10):e69-e70. doi: 10.1016/j.ophtha.2018.03.058. No abstract available.

  PMID: 30243340 RESULT

• Hartmann EE, Drews-Botsch C, DuBois LG, Cotsonis G, Lambert SR; Infant Aphakia Treatment Study Group. Correlation of monocular grating acuity at age 12 months with recognition acuity at age 4.5 years: findings from the Infant Aphakia Treatment Study. J AAPOS. 2018 Aug;22(4):299-303.e2. doi: 10.1016/j.jaapos.2018.03.011. Epub 2018 Jul 20.

  PMID: 30031874 RESULT

• Lambert SR, DuBois L, Cotsonis G, Hartmann EE, Drews-Botsch C; Infant Aphakia Treatment Study Group. Spectacle Adherence Among Four-Year-Old Children in the Infant Aphakia Treatment Study. Am J Ophthalmol. 2019 Apr;200:26-33. doi: 10.1016/j.ajo.2018.12.017. Epub 2019 Jan 8.

  PMID: 30633891 RESULT

• Drews-Botsch C, Celano M, Cotsonis G, DuBois L, Lambert SR; Infant Aphakia Treatment Study Group. Parenting Stress and Adherence to Occlusion Therapy in the Infant Aphakia Treatment Study: A Secondary Analysis of a Randomized Clinical Trial. Transl Vis Sci Technol. 2019 Jan 2;8(1):3. doi: 10.1167/tvst.8.1.3. eCollection 2019 Jan.

  PMID: 30627478 RESULT

• Lambert SR, Bothun ED, Plager DA. Five-Year Postoperative Outcomes of Bilateral Aphakia and Pseudophakia in Children up to 2 Years of Age: A Randomized Clinical Trial. Am J Ophthalmol. 2019 Mar;199:263-264. doi: 10.1016/j.ajo.2018.09.042. Epub 2018 Dec 19. No abstract available.

  PMID: 30579617 RESULT

• 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 Jun 14;8(3):41. doi: 10.1167/tvst.8.3.41. eCollection 2019 May. No abstract available.

  PMID: 31231593 RESULT

• Lambert SR, Cotsonis G, DuBois L, Nizam Ms A, Kruger SJ, Hartmann EE, Weakley DR Jr, Drews-Botsch C; Infant Aphakia Treatment Study Group. Long-term Effect of Intraocular Lens vs Contact Lens Correction on Visual Acuity After Cataract Surgery During Infancy: A Randomized Clinical Trial. JAMA Ophthalmol. 2020 Apr 1;138(4):365-372. doi: 10.1001/jamaophthalmol.2020.0006.

  PMID: 32077909 RESULT

• Lambert SR, Nizam A, DuBois L, Cotsonis G, Weakley DR Jr, Wilson ME; Infant Aphakia Treatment Study Group. The Myopic Shift in Aphakic Eyes in the Infant Aphakia Treatment Study After 10 Years of Follow-up. Eye Contact Lens. 2021 Feb 1;47(2):108-112. doi: 10.1097/ICL.0000000000000718.

  PMID: 32568929 RESULT

• Plager DA, Bothun ED, Freedman SF, Wilson ME, Lambert SR. Complications at 10 Years of Follow-up in the Infant Aphakia Treatment Study. Ophthalmology. 2020 Nov;127(11):1581-1583. doi: 10.1016/j.ophtha.2020.04.046. Epub 2020 May 11. No abstract available.

  PMID: 32437863 RESULT

• Traboulsi EI, Drews-Botsch CD, Christiansen SP, Stout AU, Hartmann EE, Lambert SR; IATS Investigator Group. Rate of ocular trauma in children operated on for unilateral cataract in infancy-data from the Infant Aphakia Treatment Study. J AAPOS. 2020 Oct;24(5):301-303. doi: 10.1016/j.jaapos.2020.06.005. Epub 2020 Aug 31.

  PMID: 32882364 RESULT

• VanderVeen DK, Drews-Botsch CD, Nizam A, Bothun ED, Wilson LB, Wilson ME, Lambert SR; Infant Aphakia Treatment Study. Outcomes of secondary intraocular lens implantation in the Infant Aphakia Treatment Study. J Cataract Refract Surg. 2021 Feb 1;47(2):172-177. doi: 10.1097/j.jcrs.0000000000000412.

  PMID: 32925650 RESULT

• McClatchey SK, McClatchey TS, Cotsonis G, Nizam A, Lambert SR; Infant Aphakia Treatment Study Group. Refractive growth variability in the Infant Aphakia Treatment Study. J Cataract Refract Surg. 2021 Apr 1;47(4):512-515. doi: 10.1097/j.jcrs.0000000000000482.

  PMID: 33181631 RESULT

• Freedman SF, Beck AD, Nizam A, Vanderveen DK, Plager DA, Morrison DG, Drews-Botsch CD, Lambert SR; Infant Aphakia Treatment Study Group. Glaucoma-Related Adverse Events at 10 Years in the Infant Aphakia Treatment Study: A Secondary Analysis of a Randomized Clinical Trial. JAMA Ophthalmol. 2021 Feb 1;139(2):165-173. doi: 10.1001/jamaophthalmol.2020.5664.

  PMID: 33331850 RESULT

• Weakley DR Jr, Nizam A, VanderVeen DK, Wilson ME, Kruger S, Lambert SR; Infant Aphakia Treatment Study Group. Myopic Shift at 10-Year Follow-up in the Infant Aphakia Treatment Study. Ophthalmology. 2022 Sep;129(9):1064-1065. doi: 10.1016/j.ophtha.2022.04.004. Epub 2022 Apr 8.

  PMID: 35398306 RESULT

• Oke I, VanderVeen DK, McClatchey TS, Lambert SR, McClatchey SK; Infant Aphakia Treatment Study Group. The accuracy of intraocular lens calculation varies by age in the Infant Aphakia Treatment Study. J AAPOS. 2022 Jun;26(3):143-145. doi: 10.1016/j.jaapos.2022.02.004. Epub 2022 May 6.

  PMID: 35534321 RESULT

• Drews-Botsch C, Cotsonis G, Celano M, Hartmann EE, Zaidi J, Lambert SR. Patching in Children With Unilateral Congenital Cataract and Child Functioning and Parenting Stress. JAMA Ophthalmol. 2024 Jun 1;142(6):503-510. doi: 10.1001/jamaophthalmol.2024.0800.

  PMID: 38635258 RESULT

• Wong C, Das U, Forbes H, Kolosky T, Cho E, Mansoor S, Chase S, Kore M, Menon R, Levin MR, Magder L, Drews-Botsch C, Lambert SR, Alexander JL. Predicting 10 Year Glaucoma Using Anterior Segment Biometry for Infants with Unilateral Congenital Cataract. Am J Ophthalmol. 2025 Dec 17;283:207-213. doi: 10.1016/j.ajo.2025.12.010. Online ahead of print.

  PMID: 41419074 DERIVED

• Hartmann EE, Drews-Botsch C, DuBois L, Lambert SR; Infant Aphakia Treatment Study Group. Stereopsis in the Infant Aphakia Treatment Study: outcome at 10(1/2) years. Eye (Lond). 2025 May;39(7):1426-1427. doi: 10.1038/s41433-025-03731-3. Epub 2025 Mar 8.

  PMID: 40057655 DERIVED

• Bothun ED, Shainberg MJ, Christiansen SP, Vanderveen DK, Neely DE, Kruger SJ, Cotsonis G, Lambert SR; Infant Aphakic Treatment Study. Long-term strabismus outcomes after unilateral infantile cataract surgery in the Infant Aphakia Treatment Study. J AAPOS. 2022 Aug;26(4):174.e1-174.e4. doi: 10.1016/j.jaapos.2022.05.003. Epub 2022 Jul 14.

  PMID: 35843488 DERIVED

• 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 Dec 11;56(1):388-95. doi: 10.1167/iovs.14-15464.

  PMID: 25503455 DERIVED

MeSH Terms

Conditions

Aphakia

Interventions

Lens Implantation, Intraocular

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Scott R Lambert, MD, Study Chairman
• Organization: Stanford University School of Medicine

lambert7@stanford.edu

650-498-4242

Study Officials

• Scott Lambert, MD

  Stanford University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Phase 3 is 10.5-year follow-up study since Phase 1. There is no intervention.

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: December 1, 2004
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: July 24, 2024
• Results First Posted: January 5, 2015

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)