Clinical trial NCT00212134: Infant Aphakia Treatment Study (IATS)
Official title: Infant Aphakia Treatment Study (IATS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Cataract
Keywords: cataract surgery
intraocular lens
contact lens
infants
aphakia
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
name: Alcon Research
name: Bausch & Lomb Incorporated
name: BSN-JOBST Inc.
name: Eye Care and Cure
First posted: 2005-09-21
Enrollment: 114
Sex: ALL
Minimum age (years): 28
Maximum age (years): 210
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 3 is 10.5-year follow-up study since Phase 1. There is no intervention.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.).

Primary outcomes:
measure: Visual Acuity
timeFrame: Phase 1 - Age 12 months
measure: Visual Acuity - Subjective Assessment at Age 4.5 Years.
timeFrame: Phase 2 - Age 4.5 Years
measure: Visual Acuity - Subjective Assessment at Age 10 Years.
timeFrame: Phase 3 - Age 10.5 Years
Secondary outcomes:
measure: Percent of Patients With 1 or More Intraoperative Complications at Cataract Surgery
timeFrame: Cataract surgery immediately after enrollment
measure: Percent of Patients With 1 or More Adverse Events
timeFrame: Study enrollment to age 5 years
measure: Parenting Stress
timeFrame: Phase 1 - 3 months post surgery
measure: Adherence to Occlusion Therapy
timeFrame: Phase 1 - 12 months follow-up
measure: Parenting Stress
timeFrame: Phase 1 - Age 12 Months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Miami
country: United States
facility: Miami Children's Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory Eye Center
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University Medical Center
state: Indiana
city: Boston
country: United States
facility: Harvard University
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Durham
country: United States
facility: Duke University Eye Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Dallas
country: United States
facility: Pediatric Ophthalmology, P.A.
state: Texas
city: Houston
country: United States
facility: Baylor University
state: Texas
Study officials:
affiliation: Stanford University
name: Scott Lambert, MD
role: STUDY_CHAIR
References:
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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: 10.1097/ICL.0000000000000718.
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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(5):301-303. doi: 10.1016/j.jaapos.2020.06.005. Epub 2020 Aug 31.
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):172-177. doi: 10.1097/j.jcrs.0000000000000412.
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.0000000000000482.
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 Randomized Clinical Trial. JAMA Ophthalmol. 2021 Feb 1;139(2):165-173. doi: 10.1001/jamaophthalmol.2020.5664.
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 Sep;129(9):1064-1065. doi: 10.1016/j.ophtha.2022.04.004. Epub 2022 Apr 8.
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.2022.02.004. Epub 2022 May 6.
citation: 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.
citation: 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.
citation: 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.