Clinical Trial: Aphakia Versus Pseudophakia in Children Under 2 Years Undergoing Bilateral Congenital Cataract Surgery

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Aphakia vs Pseudophakia - Randomized Clinical Trial in Children Under 2 Years Undergoing Bilateral Congenital Cataract Surgery

Brief Summary: The purpose of this study is to document the safety and efficacy of primary IOL implantation in children below 2 years of age undergoing congenital cataract surgery.

Detailed Summary:

The use of IOLs in pediatric patients has become increasingly popular in recent years and may represent a standard of care for older children. The refinements in surgical techniques attained in adult cataract surgery have been translated to pediatric cataract surgery to produce a technically safe eye. Nevertheless, the use of IOLs in children younger than 2 years remains controversial. Exaggerated inflammation, capsular opacification and changing refractive status of the developing eye should be considered before the use of IOLs in the first two years of life. Further more, there is concern about the unknown risks of an IOL over the long life span.

Currently, there are 3 methods of optical rehabilitation following congenital cataract surgery :

  1. Primary IOL implantation.
  2. Aphakic glasses.
  3. Contact lenses.

At present, there is no randomized clinical trial reported to document the safety and efficacy of IOL implantation in children less than 2 years.

Aim : To compare the technical outcome (safety) and functional outcome (benefits) following primary IOL implantation and aphakia in children less than 2 years.


Sponsor: Iladevi Cataract and IOL Research Center

Current Primary Outcome:

  • Visual axis obscuration [ Time Frame: 4 years ]
    Visual axis obscuration(VAO) assesed on slitlamp or under operating microscope in dilated pupil.VAO is defined as fibrous or proliferative cell growth leadind to a dull retinoscopic reflex.
  • Glaucoma [ Time Frame: 4 years ]

    Intraocular pressure (IOP) measured with Perkins handheld applanation tonometer.

    Glaucoma defined as :

    IOP>21 mmHg >1 occasion with any of these 3 criteria

    1. Optic nerve cupping asymmetry >0.2 cd ratio asymmetry , CD ratio >0.4
    2. Abnormal asymmetrical axial length elongation
    3. Corneal oedema or enlargement
  • Central Corneal Thickness [ Time Frame: 4 Years ]
    Corneal thickness assessed by ultrasonic pachymetry. An average of 3 values with an error less than 0.001 would be taken into account.


Original Primary Outcome: Same as current

Current Secondary Outcome: Visual Acuity [ Time Frame: 4 years . ]

An Objective visual assessment to be performed using Lea Grating Paddles(Grating Acuity Test developed by Lea Hyvarinen16), Cardiff Acuity Cards(Preferential Looking Test17), or ETDRS (Early Treatment of Diabetic Retinopathy Study) chart. Vision is subjectively assessed as the ability to follow or to fixate on a point source of light or on an object shown to the child.. Ocular alignment was measured using alternative cover testing. If this kind of testing was not feasible, Hirschberg testing was performed..


Original Secondary Outcome: Same as current

Information By: Iladevi Cataract and IOL Research Center

Dates:
Date Received: February 14, 2011
Date Started: May 2003
Date Completion:
Last Updated: June 30, 2011
Last Verified: June 2011