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

Primary Purpose

Congenital Cataract

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Intraocular Lens (Acrysof IOL)
No IOL
Sponsored by
Iladevi Cataract and IOL Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Cataract focused on measuring Congenital Cataract, Children younger than 2 years, Aphakia, Primary IOL Implantation

Eligibility Criteria

undefined - 24 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Iladevi Cataract & IOL Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Aphakia

Pseudophakia

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Visual axis obscuration
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
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
Central Corneal Thickness
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
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..

Full Information

First Posted
February 14, 2011
Last Updated
June 30, 2011
Sponsor
Iladevi Cataract and IOL Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01297153
Brief Title
Aphakia Versus Pseudophakia in Children Under 2 Years Undergoing Bilateral Congenital Cataract Surgery
Official Title
Aphakia vs Pseudophakia - Randomized Clinical Trial in Children Under 2 Years Undergoing Bilateral Congenital Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Iladevi Cataract and IOL Research Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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 : 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Cataract
Keywords
Congenital Cataract, Children younger than 2 years, Aphakia, Primary IOL Implantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aphakia
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Pseudophakia
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Intraocular Lens (Acrysof IOL)
Other Intervention Name(s)
Hydrophobic Acrylic IOL
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
No IOL
Intervention Description
No IOL will be implanted in these eyes
Primary Outcome Measure Information:
Title
Visual axis obscuration
Description
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.
Time Frame
4 years
Title
Glaucoma
Description
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
Time Frame
4 years
Title
Central Corneal Thickness
Description
Corneal thickness assessed by ultrasonic pachymetry. An average of 3 values with an error less than 0.001 would be taken into account.
Time Frame
4 Years
Secondary Outcome Measure Information:
Title
Visual Acuity
Description
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..
Time Frame
4 years .

10. Eligibility

Sex
All
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abhay R Vasavada, MS,FRCS
Organizational Affiliation
Iladevi Cataract And IOL Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iladevi Cataract & IOL Research Centre
City
Ahmedabad
Country
India

12. IPD Sharing Statement

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

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