Aphakia Versus Pseudophakia in Children Under 2 Years Undergoing Bilateral Congenital Cataract Surgery
|ClinicalTrials.gov Identifier: NCT01297153|
Recruitment Status : Completed
First Posted : February 16, 2011
Last Update Posted : July 1, 2011
|Condition or disease||Intervention/treatment||Phase|
|Congenital Cataract||Device: Intraocular Lens (Acrysof IOL) Device: No IOL||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Aphakia vs Pseudophakia - Randomized Clinical Trial in Children Under 2 Years Undergoing Bilateral Congenital Cataract Surgery|
|Study Start Date :||May 2003|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||May 2011|
Active Comparator: Aphakia
Prescribed within 2 weeks of surgery for both eyes.
Device: No IOL
No IOL will be implanted in these eyes
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
- 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
- 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 [ 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.
- 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..
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01297153
|Iladevi Cataract & IOL Research Centre|
|Principal Investigator:||Abhay R Vasavada, MS,FRCS||Iladevi Cataract And IOL Research Centre|