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

Iladevi Cataract and IOL Research Center

Status and phase: Completed; Phase 4

Conditions: Congenital Cataract

Treatments: Device: No IOL; Device: Intraocular Lens (Acrysof IOL)

Study type: Interventional

Funder types: Other

Identifiers

NCT01297153

icircAP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: Under 24 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Aphakia

Active Comparator group

Description:

* 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.

Treatment:

Device: No IOL

Pseudophakia

Active Comparator group

Description:

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.

Treatment:

Device: Intraocular Lens (Acrysof IOL)