Congenital Cataract
Conditions
Keywords
Congenital Cataract, Children younger than 2 years, Aphakia, Primary IOL Implantation
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 : 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.
Interventions
DEVICEIntraocular 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.
DEVICENo IOL
No IOL will be implanted in these eyes
Sponsors
Iladevi Cataract and IOL Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual axis obscuration | 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 | 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 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity | 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.. |
Countries
India
Outcome results
None listed