Aphakia vs Pseudophakia - Randomized Clinical Trial in Children Under 2 Years Undergoing Bilateral Congenital Cataract Surgery
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Visual axis obscuration
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 24 Months (Child)
- Sex
- All
- Accepts 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
- •*Glaucoma - IOP more than or equal to 25 mmHg
- •Cataract surgery already performed in fellow eye
Outcomes
Primary Outcomes
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 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
Corneal thickness assessed by ultrasonic pachymetry. An average of 3 values with an error less than 0.001 would be taken into account.
Secondary Outcomes
- Visual Acuity(4 years .)