Status:
COMPLETED
Infant Aphakia Treatment Study (IATS)
Lead Sponsor:
Stanford University
Collaborating Sponsors:
National Eye Institute (NEI)
Alcon Research
Conditions:
Congenital Cataract
Eligibility:
All Genders
28-210 years
Phase:
NA
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 implant...
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...
Eligibility Criteria
Inclusion
- 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
- 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.).
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00212134
Start Date
December 1 2004
End Date
August 31 2020
Last Update
July 24 2024
Active Locations (13)
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1
Stanford University
Palo Alto, California, United States, 94303
2
Miami Children's Hospital
Miami, Florida, United States, 33155
3
Emory Eye Center
Atlanta, Georgia, United States, 30322
4
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202-5175