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

This study has been completed.
Sponsor:
Information provided by:
Iladevi Cataract and IOL Research Center
ClinicalTrials.gov Identifier:
NCT01297153
First received: February 14, 2011
Last updated: June 30, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Congenital Cataract
 Device: Intraocular Lens (Acrysof IOL)
Device: No IOL
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Aphakia vs Pseudophakia - Randomized Clinical Trial in Children Under 2 Years Undergoing Bilateral Congenital Cataract Surgery

Resource links provided by NLM:

MedlinePlus related topics: Cataract Eye Wear
U.S. FDA Resources

Further study details as provided by Iladevi Cataract and IOL Research Center:

Primary Outcome Measures:
  • Visual axis obscuration [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    Corneal thickness assessed by ultrasonic pachymetry. An average of 3 values with an error less than 0.001 would be taken into account.


Secondary Outcome Measures:
  • Visual Acuity [ Time Frame: 4 years . ] [ Designated as safety issue: Yes ]
    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..


Estimated Enrollment: 100
Study Start Date: May 2003
Study Completion Date: May 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aphakia
  • The patient is randomly assigned for aphakia / pseudophakia. This is done only after vitrectomy. If it is aphakia,IOL will not be implanted.Aphakia will be corrected with aphakic glasses / contact lenses. Bilateral aphakes are given both contact lenses and glasses. So when they do not wear contact lenses they can put on aphakic glasses. Unilateral aphakes are given only contact lenses. Contact lenses should be fitted in the eye in OT immediately after the operation.
  • Aphakic glasses :

Prescribed within 2 weeks of surgery for both eyes.

 Device: No IOL
No IOL will be implanted in these eyes
Other Name: No iol
Active Comparator: Pseudophakia
The patient is randomly assigned for aphakia / pseudophakia. This is done only after vitrectomy. Hydrophobic Acrysof IOL is implanted.All pseudophakic children will be refracted and given the residual correction within a month of surgery.
 Device: Intraocular Lens (Acrysof IOL)
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 Name: Hydrophobic Acrylic IOL

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297153

Locations
India
Iladevi Cataract & IOL Research Centre
Ahmedabad, India
Sponsors and Collaborators
Iladevi Cataract and IOL Research Center
Investigators
Principal Investigator: Abhay R Vasavada, MS,FRCS Iladevi Cataract And IOL Research Centre
  More Information

No publications provided

Responsible Party: Dr. Abhay R. Vasavada, Iladevi Cataract & IOL Research Centre
ClinicalTrials.gov Identifier: NCT01297153     History of Changes
Other Study ID Numbers: icircAP
Study First Received: February 14, 2011
Last Updated: June 30, 2011
Health Authority: India: Indian Council of Medical Research

Keywords provided by Iladevi Cataract and IOL Research Center:
Congenital Cataract
Children younger than 2 years
Aphakia
Primary IOL Implantation

Additional relevant MeSH terms:
Aphakia
Cataract
Pseudophakia
 Lens Diseases
Eye Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013