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Cataract Surgery With Intracameral Triamcinolone in Infants

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Triamcinolone acetonide
Prednisolone syrup
Sponsored by
Fundação Altino Ventura
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

6 Weeks - 2 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Altino Ventura Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Triamcinolone acetonide

Prednisolone syrup

Arm Description

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

The control group will receive prednisolone syrup postoperatively

Outcomes

Primary Outcome Measures

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.
Intraocular pressure

Secondary Outcome Measures

Full Information

First Posted
February 25, 2013
Last Updated
August 13, 2013
Sponsor
Fundação Altino Ventura
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1. Study Identification

Unique Protocol Identification Number
NCT01800708
Brief Title
Cataract Surgery With Intracameral Triamcinolone in Infants
Official Title
The Use of Intraocular Triamcinolone in the Perioperative Period of Congenital Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundação Altino Ventura

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Triamcinolone acetonide
Arm Type
Active Comparator
Arm Description
The study group will receive an intraoperative intracameral injection of triamcinolone acetonide
Arm Title
Prednisolone syrup
Arm Type
Active Comparator
Arm Description
The control group will receive prednisolone syrup postoperatively
Intervention Type
Drug
Intervention Name(s)
Triamcinolone acetonide
Other Intervention Name(s)
Triancinolona Ophthalmos
Intervention Type
Drug
Intervention Name(s)
Prednisolone syrup
Primary Outcome Measure Information:
Title
Visual axis obscuration
Description
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.
Time Frame
1 year after surgery
Title
Intraocular pressure
Time Frame
1 year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients younger than 2 years of age Unilateral or bilateral congenital cataracts compromising the red reflex Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo Ventura, MD
Organizational Affiliation
Fundação Altino Ventura
Official's Role
Principal Investigator
Facility Information:
Facility Name
Altino Ventura Foundation
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50070020
Country
Brazil

12. IPD Sharing Statement

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Cataract Surgery With Intracameral Triamcinolone in Infants

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