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Infant Aphakia Treatment Study (IATS)

NCT00212134 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2024-07-24

Study results available
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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.

Conditions

  • Congenital Cataract

Interventions

DEVICE

Contact lens correction of aphakia

optical correction of infant surgical aphakia with Contact lens

DEVICE

Intraocular lens implantation

optical correction of surgical aphakia with intraocular lens

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • Alcon Research

    collaborator INDUSTRY

  • Bausch & Lomb Incorporated

    collaborator INDUSTRY

  • BSN-JOBST Inc.

    collaborator INDUSTRY

  • Eye Care and Cure

    collaborator INDUSTRY

  • Stanford University

    lead OTHER

Principal Investigators

  • Scott Lambert, MD · Stanford University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
28 Days
Max Age
210 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00212134 on ClinicalTrials.gov