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

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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02491918
Enrollment
61
Registered
2015-07-08
Start date
2013-04-30
Completion date
2015-04-30
Last updated
2015-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posterior Capsule Opacification, Postoperative Complications

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.

Interventions

PROCEDUREcataract surgery

cataract surgery in children

intraocular lens implantation in the capsular bag or optic capture

Sponsors

Iladevi Cataract and IOL Research Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
15 Days to 4 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Posterior capsule opacification requiring surgery12 months postoperativelyopacification of visual axis

Secondary

MeasureTime frameDescription
inflammation on slitlamp examination12 months postoperativelycell depostis
intraocular pressure in mmHg12 months postoperativelyglaucoma

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026