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Cataract Surgery With Intracameral Triamcinolone in Infants

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ClinicalTrials.gov Identifier: NCT01800708
Recruitment Status : Completed
First Posted : February 28, 2013
Last Update Posted : August 14, 2013
Sponsor:
Information provided by (Responsible Party):
Fundação Altino Ventura

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.


Condition or disease Intervention/treatment Phase
Cataract Drug: Triamcinolone acetonide Drug: Prednisolone syrup Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Intraocular Triamcinolone in the Perioperative Period of Congenital Cataract Surgery
Study Start Date : January 2010
Actual Primary Completion Date : March 2013


Arm Intervention/treatment
Active Comparator: Triamcinolone acetonide
The study group will receive an intraoperative intracameral injection of triamcinolone acetonide
Drug: Triamcinolone acetonide
Other Name: Triancinolona Ophthalmos

Active Comparator: Prednisolone syrup
The control group will receive prednisolone syrup postoperatively
Drug: Prednisolone syrup



Primary Outcome Measures :
  1. Visual axis obscuration [ Time Frame: 1 year after surgery ]
    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.

  2. Intraocular pressure [ Time Frame: 1 year after surgery ]


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Ages Eligible for Study:   6 Weeks to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01800708


Locations
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Brazil
Altino Ventura Foundation
Recife, Pernambuco, Brazil, 50070020
Sponsors and Collaborators
Fundação Altino Ventura
Investigators
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Principal Investigator: Marcelo Ventura, MD Fundação Altino Ventura

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Responsible Party: Fundação Altino Ventura
ClinicalTrials.gov Identifier: NCT01800708     History of Changes
Other Study ID Numbers: 1
First Posted: February 28, 2013    Key Record Dates
Last Update Posted: August 14, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Triamcinolone diacetate
Cataract
Lens Diseases
Eye Diseases
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors