NCT01297153

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2003

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 16, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

July 1, 2011

Status Verified

June 1, 2011

Enrollment Period

7.7 years

First QC Date

February 14, 2011

Last Update Submit

June 30, 2011

Conditions

Congenital Cataract

Keywords

Congenital CataractChildren younger than 2 yearsAphakiaPrimary IOL Implantation

Outcome Measures

Primary Outcomes (3)

  • Visual axis obscuration

    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.

    4 years

  • Glaucoma

    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

    4 years

  • Central Corneal Thickness

    Corneal thickness assessed by ultrasonic pachymetry. An average of 3 values with an error less than 0.001 would be taken into account.

    4 Years

Secondary Outcomes (1)

  • Visual Acuity

    4 years .

Study Arms (2)

Aphakia

ACTIVE COMPARATOR

* 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.

Device: No IOL

Pseudophakia

ACTIVE COMPARATOR

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)

Interventions

Intraocular Lens (Acrysof IOL)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.

Also known as: Hydrophobic Acrylic IOL
Pseudophakia
No IOLDEVICE

No IOL will be implanted in these eyes

Aphakia

Eligibility Criteria

AgeUp to 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children less than 2 years
  • Congenital cataract
  • Bilateral cataracts
  • IOL fixation - Bag/Ciliary fixated

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Iladevi Cataract & IOL Research Centre

Ahmedabad, India

Location

MeSH Terms

Conditions

Aphakia

Interventions

Lenses, Intraocular

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

LensesOptical DevicesEquipment and SuppliesProstheses and Implants

Study Officials

  • Abhay R Vasavada, MS,FRCS

    Iladevi Cataract And IOL Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 14, 2011

First Posted

February 16, 2011

Study Start

May 1, 2003

Primary Completion

January 1, 2011

Study Completion

May 1, 2011

Last Updated

July 1, 2011

Record last verified: 2011-06

Locations

IN(1)