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

Congenital Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01297153
• Other study ID #: icircAP
• Status: Completed
• Phase: Phase 4
• First received: February 14, 2011
• Last updated: June 30, 2011
• Start date: May 2003
• Est. completion date: May 2011

Study information

• Verified date: June 2011
• Source: Iladevi Cataract and IOL Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Congenital Cataract
• Pseudophakia

Intervention

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.
• No IOL
No IOL will be implanted in these eyes

Locations

Country	Name	City	State
India	Iladevi Cataract & IOL Research Centre	Ahmedabad

Sponsors (1)

Lead Sponsor	Collaborator
Iladevi Cataract and IOL Research Center

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 years	Yes
Primary	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	4 years	Yes
Primary	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.	4 Years	Yes
Secondary	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..	4 years .	Yes