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Aphakia Versus Pseudophakia in Children Under 2 Years Undergoing Bilateral Congenital Cataract Surgery

NCT01297153 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2011-07-01

No results posted yet for this study

Summary

The purpose of this study is to document the safety and efficacy of primary IOL implantation in children below 2 years of age undergoing congenital cataract surgery.

Conditions

  • Congenital Cataract

Interventions

DEVICE

Intraocular Lens (Acrysof IOL)

IOL fixation, material and size are important determinants of immediate and long-term outcome. In-the-bag fixation is the most preferred site of IOL implantation.

DEVICE

No IOL

No IOL will be implanted in these eyes

Sponsors & Collaborators

  • Iladevi Cataract and IOL Research Center

    lead OTHER

Principal Investigators

  • Abhay R Vasavada, MS,FRCS · Iladevi Cataract And IOL Research Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-05-31
Primary Completion
2011-01-31
Completion
2011-05-31

Countries

  • India

Study Locations

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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 NCT01297153 on ClinicalTrials.gov