Infant Aphakia Treatment Study (IATS)

Congenital Cataract Clinical Trial

— IATS  

Official title:

Infant Aphakia Treatment Study (IATS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00212134
• Other study ID #: IRB00024837
• Secondary ID: U10EY013272EY013
• Status: Completed
• Phase: N/A
• Start date: December 2004
• Est. completion date: August 31, 2020

Study information

• Verified date: June 2022
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Intraocular lenses are now a commonly accepted treatment for cataracts in older children and are used increasingly in younger children and infants. Intraocular lenses are superior to contact lenses in that they more closely replicate the optics of the crystalline lens, do not require daily ongoing care, and ensure at least a partial optical correction at all times. The simplicity and improved visual outcome of an intraocular lens correction may make caring for a child with a unilateral congenital cataract less stressful for parents. However, contact lenses remain the accepted treatment for children under 1 year of age due to concerns about the long-term safety of intraocular lenses and the potential for a large myopic shift developing in these eyes as they grow. Contact lenses provide excellent visual results in infants treated for bilateral congenital cataracts; however, two-thirds of infants treated with contact lenses for unilateral congenital cataracts remain legally blind in their aphakic eye. These poor visual outcomes are usually ascribed to competition from the sound eye and poor compliance with patching and contact lens wear regimens. Data from our pilot study and the literature suggest that superior visual results can be obtained if an intraocular lens is used to correct unilateral aphakia during infancy, but these eyes will experience more complications. Intraocular lenses will be increasingly implanted in infants regardless of whether or not we perform this trial. By performing this clinical trial, we can determine if the higher rate of complications with intraocular lenses is offset by improved visual outcome and decreased parenting stress.

The Infant Aphakia Treatment Study (IATS) is a multi-center randomized clinical trial comparing intraocular lens and contact lens correction for monocular aphakia. Infants will be enrolled over a 4 year period. Infants 28 to 210 days of age with a visually significant cataract in one eye are eligible. Cataract surgery will be performed in a standardized fashion by a surgeon who has been certified for the study. Surgery consists of a lensectomy, posterior capsulotomy, and anterior vitrectomy. Infants will be randomized at the time of surgery to one of two treatment groups. Infants randomized to the intraocular lens group will have an intraocular lens implanted into the capsular bag. Spectacles will subsequently be used to correct the residual refractive errors. Infants randomized to the contact lens group will be fitted with a contact lens immediately after surgery. Both groups will receive the same patching therapy and follow-up. All children will be examined by Investigators at fixed intervals using standard protocols with the major endpoint assessed at age 12 months by a Traveling Vision Examiner.

We are currently in a continuation of this project (beyond 5 years) in order to assess which of these patients have glaucoma or glaucoma suspect at age 10.5 years. Our goal is to understand which type of initial optical correction, an IOL or a CL, results in the best long-term visual outcome following unilateral congenital cataract surgery during infancy. Our central hypothesis is that primary IOL implantation will result in a better visual outcome. The rationale for this proposal is that final visual acuity cannot be determined by 5 years of age and the recommendation for early treatment can only be substantiated by adequate long-term assessment in this unique cohort. We chose a follow-up to age 10.5 years because it will provide a more accurate assessment of visual acuity and will allow us to diagnosis most cases of glaucoma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 210 Days

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.).

Related Conditions & MeSH terms

• Aphakia
• Cataract
• Congenital Cataract

Intervention

Device:
• Contact lens correction of aphakia
optical correction of infant surgical aphakia with Contact lens
• Intraocular lens implantation
optical correction of surgical aphakia with intraocular lens

Locations

Country	Name	City	State
United States	Emory Eye Center	Atlanta	Georgia
United States	Harvard University	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Pediatric Ophthalmology, P.A.	Dallas	Texas
United States	Duke University Eye Center	Durham	North Carolina
United States	Baylor University	Houston	Texas
United States	Indiana University Medical Center	Indianapolis	Indiana
United States	Miami Children's Hospital	Miami	Florida
United States	University of Minnesota	Minneapolis	Minnesota
United States	Vanderbilt University	Nashville	Tennessee
United States	Stanford University	Palo Alto	California
United States	Oregon Health and Science University	Portland	Oregon

Sponsors (6)

Lead Sponsor	Collaborator
Stanford University	Alcon Research, Bausch & Lomb Incorporated, BSN-JOBST Inc., Eye Care and Cure, National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (67)

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 — View Citation

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.op — View Citation

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.j — View Citation

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 — View Citation

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. — View Citation

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): — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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 Sc — View Citation

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 — View Citation

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. Epub 2016 May 30. — View Citation

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 — View Citation

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. — View Citation

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 Ophthalm — View Citation

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 Randomize — View Citation

Freedman SF, Lynn MJ, Beck AD, Bothun ED, Örge 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;13 — View Citation

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 AA — View Citation

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 — View Citation

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: — View Citation

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: gr — View Citation

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 c — View Citation

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

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 — View Citation

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 — View Citation

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. Review. — View Citation

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 — View Citation

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 Infan — View Citation

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 — View Citation

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 201 — View Citation

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.2018.12.01 — View Citation

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 No — View Citation

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. — View Citation

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: — View Citation

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 AAP — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 I — View Citation

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.00000000000004 — View Citation

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.opht — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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 — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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) — View Citation

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 — View Citation

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- — View Citation

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 Ophtha — View Citation

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. — View Citation

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 S — View Citation

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: 1 — View Citation

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. 2 — View Citation

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 — View Citation

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. — View Citation

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 Apr 8. pii: S0161-6420(22)00259-7. doi: 10.1016/j.op — View Citation

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. do — View Citation

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. — View Citation

* Note: There are 67 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Percent of Patients With 1 or More Intraoperative Complications at Cataract Surgery	Percent of Patients with 1 or More Intraoperative Complications at Cataract Surgery	Cataract surgery immediately after enrollment
Secondary	Percent of Patients With 1 or More Adverse Events		Study enrollment to age 5 years
Secondary	Parenting Stress	The PSI is a 120-item validated self-report measure of parenting stress. PSI is a continuous scale measuring stress with a range of 131 (low stress) to 320 (high stress); the average person's stress scores are between 188 and 252.	Phase 1 - 3 months post surgery
Secondary	Adherence to Occlusion Therapy	Parental report of the number of hours children wore an patch to occlude the fellow eye.	Phase 1 - 12 months follow-up
Secondary	Parenting Stress	The PSI is a 120-item validated self-report measure of parenting stress. PSI is a continuous scale measuring stress with a range of 131 (low stress) to 320 (high stress); the average person's stress scores are between 188 and 252	Phase 1 - Age 12 Months

External Links

•   NEI Clinical Studies Database--Infant Aphakia Treatment Study (IATS)