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Completed

NCT Number: NCT01297153

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

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.

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Key information

Conditions

Congenital Cataract Aphakia Eye Diseases Lens Diseases

Age range

Up to 24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Iladevi Cataract & IOL Research Centre

Ahmedabad, India

About this study

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 :

  • Primary IOL implantation.
  • Aphakic glasses.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children less than 2 years
  • Congenital cataract
  • Bilateral cataracts
  • IOL fixation - Bag/Ciliary fixated

Exclusion criteria

  • Microphthalmos (Mean axial length 2 SDs less than normal for age)
  • Microcornea (Horizontal corneal diameter <9.5 mm-asper that particular age)
  • Iris coloboma
  • PHPV
  • Aniridia
  • *Glaucoma - IOP more than or equal to 25 mmHg
  • One eyed
  • Cataract surgery already performed in fellow eye

Treatment and study plan

Intraocular Lens (Acrysof IOL)

Device

IOL fixation, material and size are important determinants of immediate and long-term outcome. In-the-bag fixation is the most preferred site of IOL implantation.

Other names: Hydrophobic Acrylic IOL

No IOL

Device

No IOL will be implanted in these eyes

Primary outcomes

  1. 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.

  2. 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

    • Optic nerve cupping asymmetry >0.2 cd ratio asymmetry , CD ratio >0.4
    • Abnormal asymmetrical axial length elongation
    • Corneal oedema or enlargement

  3. 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.

Secondary outcomes

  1. 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..

Sponsors and collaborators

Lead sponsor

Iladevi Cataract and IOL Research Center

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2011
Study completion
2011
First posted
Feb 16, 2011
Registry last updated
Jul 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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