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Clinical Trial : Complications of in the Bag IOL Versus Optic Capture of IOL in Pediatric Cataract Surgery

NCT02491918 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2015-07-08

No results posted yet for this study

Summary

This prospective, randomized, clinical trial looks to compare children undergoing congenital cataract surgery with intraocular lens (IOL) implantation in terms of visual axis obscuration as well as postoperative complications such as glaucoma, inflammation and IOL centration when IOL fixation is performed using two different techniques : 1) conventional in the bag IOL implantation with anterior vitrectomy, and, 2) posterior optic capture of the IOL through the posterior capsulorhexis without any vitrectomy. 61 eyes of 61 children randomized to receiving IOL implantation using one of the two techniques will be followed up until 12 months postoperatively.

Conditions

  • Posterior Capsule Opacification
  • Postoperative Complications

Interventions

PROCEDURE

cataract surgery

cataract surgery in children

PROCEDURE

Intraocular lens implantation

intraocular lens implantation in the capsular bag or optic capture

Sponsors & Collaborators

  • Iladevi Cataract and IOL Research Center

    lead OTHER

Principal Investigators

  • abhay vasavada, MS,FRCS · Iladevi Cataract & IOL Research Centre, Ahmedabad, India

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Days
Max Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-04-30
Completion
2015-04-30

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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 NCT02491918 on ClinicalTrials.gov