Infant Aphakia Treatment Study (IATS) (IATS)
Congenital Cataract
About this trial
This is an interventional treatment trial for Congenital Cataract focused on measuring cataract surgery, intraocular lens, contact lens, infants, aphakia
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.).
Sites / Locations
- Stanford University
- Miami Children's Hospital
- Emory Eye Center
- Indiana University Medical Center
- Harvard University
- University of Minnesota
- Duke University Eye Center
- Cleveland Clinic Foundation
- Oregon Health and Science University
- Medical University of South Carolina
- Vanderbilt University
- Pediatric Ophthalmology, P.A.
- Baylor University
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
aphakic contact lens
aphakic intraocular lens
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.
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.