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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2011-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Congenital Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aphakia

* 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.

Group Type ACTIVE_COMPARATOR

No IOL

Intervention Type DEVICE

No IOL will be implanted in these eyes

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.

Group Type ACTIVE_COMPARATOR

Intraocular Lens (Acrysof IOL)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

No IOL

No IOL will be implanted in these eyes

Intervention Type DEVICE

Other Intervention Names

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Hydrophobic Acrylic IOL

Eligibility Criteria

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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

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No