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

Primary Purpose

Posterior Capsule Opacification, Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
cataract surgery
Intraocular lens implantation
Sponsored by
Iladevi Cataract and IOL Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Posterior Capsule Opacification

Eligibility Criteria

15 Days - 4 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • uncomplicated cataract,
  • unilateral or bilateral cataract,
  • corneal diameter >9.0mmHg

Exclusion Criteria:

  • pre-existing glaucoma,
  • uveitis,
  • ocular comorbidity,
  • microphthalmos,
  • microcornea,
  • parents not consenting to participate in study,
  • traumatic cataract

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    In the bag IOL

    Optic Capture of IOL

    Arm Description

    Cataract surgery with IOL implantation in the capsular bag

    intraocular lens implantation in the capsular bag with posterior optic capture

    Outcomes

    Primary Outcome Measures

    Posterior capsule opacification requiring surgery
    opacification of visual axis

    Secondary Outcome Measures

    inflammation on slitlamp examination
    cell depostis
    inflammation on slitlamp examination
    posterior synechiae
    intraocular pressure in mmHg
    glaucoma

    Full Information

    First Posted
    June 29, 2015
    Last Updated
    July 2, 2015
    Sponsor
    Iladevi Cataract and IOL Research Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02491918
    Brief Title
    Clinical Trial : Complications of in the Bag IOL Versus Optic Capture of IOL in Pediatric Cataract Surgery
    Official Title
    Visual Axis Obscuration and Postoperative Complications Following Pediatric Cataract Surgery With Introacular Lens Implantation In-the-bag Versus Posterior Optic Capture : A Randomized, Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2013 (undefined)
    Primary Completion Date
    April 2015 (Actual)
    Study Completion Date
    April 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Iladevi Cataract and IOL Research Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    Detailed Description
    This prospective, randomized, controlled, clinical trial compares visual axis obscuration as well as intra and postoperative complications in children undergoing cataract surgery with IOL implantation using one of two techniques : in the bag IOL with limbal anterior vitrectomy posterior optic capture of IOL optic through the posterior capsulorhexis without any vitrectomy. The aim is to evaluate whether avoiding anterior vitrectomy is a feasible option, particularly younger children, where anterior vitrectomy has become an integral part of the routine surgical strategy. All children will be evaluated at 1 month, 3 months, 6 months and 12 months postoperatively.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Posterior Capsule Opacification, Postoperative Complications

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    61 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    In the bag IOL
    Arm Type
    Active Comparator
    Arm Description
    Cataract surgery with IOL implantation in the capsular bag
    Arm Title
    Optic Capture of IOL
    Arm Type
    Active Comparator
    Arm Description
    intraocular lens implantation in the capsular bag with posterior optic capture
    Intervention Type
    Procedure
    Intervention Name(s)
    cataract surgery
    Intervention Description
    cataract surgery in children
    Intervention Type
    Procedure
    Intervention Name(s)
    Intraocular lens implantation
    Intervention Description
    intraocular lens implantation in the capsular bag or optic capture
    Primary Outcome Measure Information:
    Title
    Posterior capsule opacification requiring surgery
    Description
    opacification of visual axis
    Time Frame
    12 months postoperatively
    Secondary Outcome Measure Information:
    Title
    inflammation on slitlamp examination
    Description
    cell depostis
    Time Frame
    12 months postoperatively
    Title
    inflammation on slitlamp examination
    Description
    posterior synechiae
    Time Frame
    12 months postoperatively
    Title
    intraocular pressure in mmHg
    Description
    glaucoma
    Time Frame
    12 months postoperatively

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Days
    Maximum Age & Unit of Time
    4 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: uncomplicated cataract, unilateral or bilateral cataract, corneal diameter >9.0mmHg Exclusion Criteria: pre-existing glaucoma, uveitis, ocular comorbidity, microphthalmos, microcornea, parents not consenting to participate in study, traumatic cataract
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    abhay vasavada, MS,FRCS
    Organizational Affiliation
    Iladevi Cataract & IOL Research Centre, Ahmedabad, India
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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