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
About this trial
This is an interventional prevention trial for Posterior Capsule Opacification
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
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
NCT ID
NCT02491918
First Posted
June 29, 2015
Last Updated
July 2, 2015
Sponsor
Iladevi Cataract and IOL Research Center
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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