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

Postoperative Complications Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02491918
• Other study ID #: 13-009
• Secondary ID: 2013 Research Fo
• Status: Completed
• Phase: N/A
• First received: June 29, 2015
• Last updated: July 2, 2015
• Start date: April 2013
• Est. completion date: April 2015

Study information

• Verified date: July 2015
• Source: Iladevi Cataract and IOL Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Data Monitoring Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 4 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Capsule Opacification
• Posterior Capsule Opacification
• Postoperative Complications

Intervention

Procedure:
• cataract surgery
cataract surgery in children
• Intraocular lens implantation
intraocular lens implantation in the capsular bag or optic capture

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Iladevi Cataract and IOL Research Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Posterior capsule opacification requiring surgery	opacification of visual axis	12 months postoperatively	No
Secondary	inflammation on slitlamp examination	cell depostis	12 months postoperatively	Yes
Secondary	inflammation on slitlamp examination	posterior synechiae	12 months postoperatively	Yes
Secondary	intraocular pressure in mmHg	glaucoma	12 months postoperatively	Yes