CClinicalTrials.gg
CompletedNCT02491918Updated Jul 8, 2015

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

An interventional study of cataract surgery and Intraocular lens implantation in Posterior Capsule Opacification and Postoperative Complications, sponsored by Iladevi Cataract and IOL Research Center. Completed. Open to participants aged 15 Days to 4 Years. Per ClinicalTrials.gov, last updated 2015-07-08.

Sponsored by Iladevi Cataract and IOL Research Center · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
15 Days to 4 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Posterior Capsule Opacification
  • Postoperative Complications
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 61 is below the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Iladevi Cataract and IOL Research Center is the lead sponsor of 20 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Days to 4 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • pre-existing glaucoma,
  • uveitis,
  • ocular comorbidity,
  • microphthalmos,
  • microcornea,
  • parents not consenting to participate in study,
  • traumatic cataract
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
61 participants (actual)

Study arms

  • Active comparator
    In the bag IOL

    Cataract surgery with IOL implantation in the capsular bag

    Procedure: cataract surgery · Procedure: Intraocular lens implantation

  • Active comparator
    Optic Capture of IOL

    intraocular lens implantation in the capsular bag with posterior optic capture

    Procedure: cataract surgery · Procedure: Intraocular lens implantation

Interventions

  • Procedurecataract surgery

    cataract surgery in children

  • ProcedureIntraocular lens implantation

    intraocular lens implantation in the capsular bag or optic capture

06

What researchers measure

Primary outcomes

  1. Posterior capsule opacification requiring surgery

    opacification of visual axis

    Time frame: 12 months postoperatively

Secondary outcomes

  1. inflammation on slitlamp examination

    cell depostis

    Time frame: 12 months postoperatively

  2. inflammation on slitlamp examination

    posterior synechiae

    Time frame: 12 months postoperatively

  3. intraocular pressure in mmHg

    glaucoma

    Time frame: 12 months postoperatively

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 8, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02491918
Lead sponsor
Iladevi Cataract and IOL Research Center
Responsible party
Abhay R. Vasavada (Director, Iladevi Cataract and IOL Research Center) — Principal investigator
First posted
Jul 8, 2015
Start date
Apr 2013
Primary completion
Apr 2015
Completion
Apr 2015
Last update
Jul 8, 2015

Study contacts

abhay vasavada, MS,FRCS
study director · Iladevi Cataract & IOL Research Centre, Ahmedabad, India

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion