CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 114 enrolled
Drug / intervention
Contact lens correction of aphakia +1 moredevice
Likely dose
Not stated in record
Key inclusion· 2
  • Visually significant unilateral congenital cataract with central opacity ≥3 mm
  • Cataract surgery performed between 28–210 postnatal days at ≥41 post-conceptional weeks
Key exclusion· 12
  • Cataract known to be acquired from trauma or postnatal treatment (radiation, medical therapy)
  • Corneal diameter <9 mm in horizontal meridian
  • Intraocular pressure ≥25 mmHg in affected eye
  • Persistent fetal vasculature causing ciliary stretching or tractional retinal detachment

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00212134
NCT00212134N/ACompleted

Infant Aphakia Treatment Study (IATS)

Stanford University·interventional·Posted Sep 21, 2005·Updated Jul 24, 2024

In Brief

A clinical study evaluating Contact lens correction of aphakia and Intraocular lens implantation for Congenital Cataract. Completed, enrolled 114 participants across 13 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 21, 2005
Enrollment StartDec 1, 2004
Primary CompletionAug 31, 2020
TodayJul 2, 2026
Enrollment to primary: 15.8 yearsPosted 20.8 years ago

Interventions

Contact lens correction of aphakiadevice

optical correction of infant surgical aphakia with Contact lens

Intraocular lens implantationdevice

optical correction of surgical aphakia with intraocular lens