Infant Aphakia Treatment Study (IATS) (NCT00212134) | Clinical Trial Compass
CompletedNot Applicable
Infant Aphakia Treatment Study (IATS)
United States114 participantsStarted 2004-12
Plain-language 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.
Who can participate
Age range28 Days – 210 Days
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Visual Acuity
Timeframe: Phase 1 - Age 12 months
2
Visual Acuity - Subjective Assessment at Age 4.5 Years.
Timeframe: Phase 2 - Age 4.5 Years
3
Visual Acuity - Subjective Assessment at Age 10 Years.