Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2026-03-08 @ 11:44 PM
Study NCT ID:
NCT02491918
Status:
COMPLETED
Last Update Posted:
2015-07-08
First Post:
2015-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial : Complications of in the Bag IOL Versus Optic Capture of IOL in Pediatric Cataract Surgery
Sponsor:
Iladevi Cataract and IOL Research Center
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 :
1. in the bag IOL with limbal anterior vitrectomy
2. 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.
1. in the bag IOL with limbal anterior vitrectomy
2. 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2013 Research Foundation Grant | OTHER_GRANT | ASCRS Foundation Research Grant | View |