N/A
N=114
Infant Aphakia Treatment Study (IATS)
Congenital Cataract
Bottom Line
View on ClinicalTrials.gov: NCT00212134 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: Primary: Visual Acuity — 0.80; 0.97 logMAR units — p=0.19
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Contact lens correction of aphakia (Device); Intraocular lens implantation (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Aug 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Acuity |
0.80; 0.97 | 0.19 |
| PRIMARY Visual Acuity - Subjective Assessment at Age 4.5 Years. |
0.90; 0.90 | 0.54 |
| PRIMARY Visual Acuity - Subjective Assessment at Age 10 Years. |
0.86; 0.89 | 0.82 |
| SECONDARY Percent of Patients With 1 or More Intraoperative Complications at Cataract Surgery |
11; 28 | 0.03 sig |
| SECONDARY Percent of Patients With 1 or More Adverse Events |
56; 81 | 0.008 sig |
| SECONDARY Parenting Stress |
202.6; 208.3 | >0.05 |
| SECONDARY Adherence to Occlusion Therapy |
3.92; 3.63 | — |
| SECONDARY Parenting Stress |
202.6; 208.3 | >0.05 |
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.
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.).
Data sourced from ClinicalTrials.gov (NCT00212134). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.