Infant Aphakia Treatment Study (IATS)

Completed · Not applicable

Conditions studied: Congenital Cataract

In brief

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.

Key facts

Study ID

NCT00212134

Run by

Stanford University

People needed

114

Starts

2004-12-01

Expected to finish

2020-08-31

Last updated by the study team

2024-07-24

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

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.).

Where it is running

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

Full record on ClinicalTrials.gov

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