NCT01800708

Brief Summary

The aim of the present study is to investigate the outcomes of congenital cataract surgery when injecting intraoperative intracameral triamcinolone versus the postoperative use of oral prednisolone. This is a prospective, randomized clinical trial. Sixty children will be submitted to congenital cataract surgery younger than 2 years of age. They will be randomly divided in two groups. The study group will receive an intraoperative intracameral triamcinolone acetonide injection. The control group will receive prednisolone syrup postoperatively. The surgical outcomes will be assessed after one year.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

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

January 1, 2010

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2013

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Last Updated

August 14, 2013

Status Verified

August 1, 2013

Enrollment Period

3.2 years

First QC Date

February 25, 2013

Last Update Submit

August 13, 2013

Conditions

Cataract

Outcome Measures

Primary Outcomes (2)

  • Visual axis obscuration

    Visual axis obscuration will be evaluated under sedation, with a dilated pupil. All patients will be classified by the principal investigator as having or not a significant visual axis obscuration, based on the red reflex.

    1 year after surgery

  • Intraocular pressure

    1 year after surgery

Study Arms (2)

Triamcinolone acetonide

ACTIVE COMPARATOR

The study group will receive an intraoperative intracameral injection of triamcinolone acetonide

Drug: Triamcinolone acetonide

Prednisolone syrup

ACTIVE COMPARATOR

The control group will receive prednisolone syrup postoperatively

Drug: Prednisolone syrup

Interventions

Triamcinolone acetonideDRUG
Also known as: Triancinolona Ophthalmos
Triamcinolone acetonide
Prednisolone syrupDRUG
Prednisolone syrup

Eligibility Criteria

Age6 Weeks - 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients younger than 2 years of age
  • Unilateral or bilateral congenital cataracts compromising the red reflex

You may not qualify if:

  • Corneal opacity
  • Glaucoma
  • Aniridia
  • Subluxated cataract
  • Traumatic cataract
  • Complex microphthalmia
  • Persistant hyperplastic primary vitreous
  • Retinal detachment
  • Patients with intraoperative complications, such as IOL implanted in the sulcus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Altino Ventura Foundation

Recife, Pernambuco, 50070020, Brazil

Location

MeSH Terms

Conditions

Cataract

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

TriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Marcelo Ventura, MD

    Fundação Altino Ventura

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2013

First Posted

February 28, 2013

Study Start

January 1, 2010

Primary Completion

March 1, 2013

Last Updated

August 14, 2013

Record last verified: 2013-08

Locations

BR(1)